YEAR-END REPORT - 2020 Published 21-Dec-2020 HPTS Issue Brief 12-21-20.36 Health Policy Tracking Service - Issue Briefs Pharmaceuticals and Medical Devices Business Practices This Issue Brief was written by David J. Steiner, J.D., a contributing writer and member of the Ohio bar. 12/21/2020 I. Introduction The Department of Justice recently announced that Massachusetts-based DUSA Pharmaceuticals, Inc. (DUSA), a subsidiary of Sun Pharmaceutical Industries, Inc. (Sun Pharma), has agreed to pay the United States $20.75 million to resolve allegations that DUSA caused physicians to submit false claims to Medicare and the Federal Employee Health Benefit Program by knowingly promoting an administration process for the drug Levulan Kerastick that contradicted the product instructions approved by the U.S. Food and Drug Administration (FDA) and was unsupported by sufficient clinical evidence. The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline plc, Johnson & Johnson, Merck, Moderna, Inc., Novavax, Inc., Pfizer Inc., and Sanofi recently announced a pledge outlining a “united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.” U.S. Senator Tammy Baldwin (D-WI), a member of the Senate Committee on Health, Education, Labor and Pensions (HELP), is leading a bipartisan group of lawmakers in calling for enforcement action to address practices of pharmaceutical companies that, according to Senator Baldwin, threaten to undermine the 340B Drug Pricing Program during the COVID-19 public health emergency. The U.S. Department of Justice recently announced a global resolution of its criminal and civil investigations into the opioid manufacturer Purdue Pharma LP (Purdue), and a civil resolution of its civil investigation into individual shareholders from the Sackler family. The criminal resolution includes the largest penalties ever levied against a pharmaceutical manufacturer, including a criminal fine of $3.544 billion and an additional $2 billion in criminal forfeiture. For the $2 billion forfeiture, the company will pay $225 million on the effective date of the bankruptcy. Pfizer Inc. and BioNTech SE recently announced that their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection. This conclusion was based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study. II. Legal Actions and settlements Oklahoma announces $8.75 million settlement with Endo over alleged role in opioid crisis Oklahoma Attorney General Mike Hunter recently announced that the state has reached an out-of-court settlement with Endo Pharmaceuticals totaling $8.75 million for the company's alleged role in the state's opioid crisis. The majority of the settlement money will go into the Opioid Lawsuit Settlement Fund, along with a settlement with Teva that was reached last June. The money will remain in the account until legislation is passed to utilize the funds. According to Attorney General Hunter, “The money from this settlement as well as the money from other settlements will allow us to begin abating Oklahoma's problem. Communities in our state continue to struggle with addiction and the fallout from the ongoing opioid crisis. It's estimated as many as 100,000 Oklahomans continue struggling with addiction and every 25 minutes a baby is born suffering from opioid withdrawal. We look forward to working with members of the legislature and executive branch to ensure this money goes toward helping those who have been affected by or those who continue to struggle with opioid addiction.” © 2021 Thomson Reuters. No claim to original U.S. Government Works. -1- In addition to the settlement funds, Endo agrees that it will not employ or contract with sales representatives to promote opioids in the state of Oklahoma. The company will also not use speakers, key opinion leaders, or speaking events to promote opioids in the state. Endo also agreed to refrain from providing direct or indirect financial support for branded or unbranded information promoting opioids, such as brochures, newsletters, books and guides in Oklahoma In 2016, Endo changed its executive leadership team and stopped promoting opioid products to healthcare professionals. It also eliminated its entire pain product salesforce. Endo withdrew Opana ER from the market, discontinued the research and development of new opioid products, and implemented additional anti-diversion measures, including product serialization aimed at stopping counterfeiting and theft to protect patient safety. Attorney General Hunter further noted that, “The measures taken by Endo to alleviate the opioid epidemic are commendable. When they saw a problem, corporate executives proactively worked, internally and with stakeholders, to find a solution, not a cover-up, as we [FN2] have discovered with numerous other companies during our years-long investigation.” Teva settles False Claims Act and Anti-Kickback lawsuit for $54 million; government chose not to intervene Attorney Eric. L. Young of law firm McEldrew Young recently announced that Teva Pharmaceuticals USA, Inc., Teva Neuroscience, Inc., and Teva Sales and Marketing, Inc. ('Teva') have settled allegations in a qui tam complaint for $54 million. The lawsuit was filed by McEldrew Young, Attorneys-at-Law, and co-counsel, Shepherd, Finkelman, Miller & Shah, LLP ('SFMS'). The lawsuit was filed on behalf of two relators who previously worked as sales representatives for the company. The allegations in the qui tam complaint set forth a scheme by the company to induce physicians to write prescriptions for the drugs Copaxone and Azilect by paying them as ‘speakers' or ‘consultants,’ when many of the programs at issue were sham events. As a result of TEVA's allegedly illegal payments, the physicians prescribed Copaxone, which treats relapsing-remitting multiple sclerosis, and Azilect, which treats symptoms of Parkinson's disease. These doctors also allegedly influenced other prescribers to do the same. According to the complaint, physicians who participated in the alleged sham speaker programs wrote prescriptions for the two drugs that were filled at pharmacies across the country. After filling and dispensing the prescriptions, the pharmacies then submitted claims for reimbursement to various government-funded health care programs. The pharmacies' claims resulted in payments by the government for prescriptions that were allegedly induced through fraud. Since Teva's actions allegedly caused the submission of false claims to the government via the dispensing pharmacies, it was claimed that those actions constituted violations of the False Claims Act ('FCA'), 31 U.S.C. ?? 3729-3733. The complaint also alleged violations of the Anti-Kickback Statute ('AKS'), 42 U.S.C. ? 1320a -7b, which criminalizes ‘knowingly or willingly’ offering or paying a person ‘remuneration,’ in the form of kickbacks, bribes, or rebates, to ‘induce’ that person to ‘recommend’ the purchase of a drug covered by a ‘Federal health care program.’ 42 U.S.C. ? 1320a-7b(b)(2). The AKS generally prohibits a pharmaceutical manufacturer from offering, directly or indirectly, any remuneration to induce a physician to prescribe, or a Medicare patient to purchase, that manufacturer's drugs. McEldrew Young and SFMS filed the original qui tam complaint on behalf of the relators in May 2013. The complaint alleged that, beginning in 2003, TEVA provided bogus honoraria or speaking fees to physicians for participation in numerous sham speaker programs in connection with the drugs Azilect and Copaxone. On November 18, 2014, the United States, along with the various state and municipal governments that were also named as plaintiffs in the complaint, notified the Court of their decision to decline intervention in the case. On March 12, 2015, the Court issued an Order unsealing the complaint while confirming that the various governments had declined to intervene in the action. According to Attorney Eric Young, ‘This settlement helps ensure that when a physician chooses a prescription drug for his or her patient, that choice will be motivated solely by the best interests of the patient and not tainted by any improper financial considerations.” Mr. Young also stated that, ‘We were inspired by the level of our clients' commitment to hold TEVA accountable for its alleged misconduct. Today's result is also a victory for American taxpayers who are the ultimate victims when unscrupulous individuals and [FN3] companies defraud the government, oftentimes with impunity.’ Medical device maker Resmed Corp. to pay $37.5 million for alleged violations of False Claims Act; also enters into corporate integrity agreement with HHS Inspector General The U.S. Department of Justice recently announced that San Diego-based ResMed Corp., a manufacturer of durable medical equipment (DME), has agreed to pay more than $37.5 million to resolve alleged False Claims Act violations for paying kickbacks to DME suppliers, sleep labs, and other health care providers. The Anti-Kickback Statute prohibits the knowing and willful payment of any remuneration to induce the referral of services or items that are paid for by a federal healthcare program, such as Medicare, Medicaid, or TRICARE. Claims submitted to these programs in violation of the Anti-Kickback Statute give rise to liability under the False Claims Act. The settlement resolves allegations that ResMed: © 2021 Thomson Reuters. No claim to original U.S. Government Works. -2- • provided DME companies with free telephone call center services and other free patient outreach services that enabled these companies to order resupplies for their patients with sleep apnea; • provided sleep labs with free and below-cost positive airway pressure masks and diagnostic machines, as well as free installation of these machines; • arranged for, and fully guaranteed the payments due on, interest-free loans that DME supplies acquired from third-party financial institutions for the purchase of ResMed equipment; and • provided non-sleep specialist physicians free home sleep testing devices referred to as “ApneaLink.” According to Assistant Attorney General Jody Hunt of the Department of Justice's Civil Division, “Paying any type of illegal remuneration to induce patient referrals undermines the integrity of our nation's health care system. When a patient receives a prescription for a device to treat a health care condition, the patient deserves to know that the device was selected based on quality of care considerations and not on unlawful payments from equipment manufacturers.” Lance Crick, Acting U. S. Attorney for the District of South Carolina, also commented on the settlement, stating that, “This settlement represents another example of our district's commitment to prosecuting violations of the False Claims Act and the Anti-Kickback Statute. Medical decisions should be based on what is in the best interest of the patient and not based on financial incentives and related schemes.” ResMed also entered into a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General. The CIA requires, among other things, that ResMed implement additional controls around its product pricing and sales and that ResMed conduct internal and external monitoring of its arrangements with referral sources. Katherine L. Parker, Civil Chief, U.S. Attorney's Office for the Southern District of California, stated that, “Medical decisions should always be made without outside influence caused by cash payments, free goods, or other types of illegal remuneration, and we will continue to take action to prevent attempts to induce medical decisions through illegal kickbacks. We applaud the whistleblower for coming forward and notifying the United States.” The agreement resolves five lawsuits originally brought by whistleblowers under the qui tam, or whistleblower, provisions of the False Claims. The False Claims Act permits private citizens with knowledge of fraud against the government to bring a lawsuit on behalf of the United States and to share in the recovery. The whistleblowers will collectively receive approximately $6.2 million of the settlement. The settlement was the result of a coordinated effort by the Civil Division of the United States Department of Justice; the U.S. Attorney's Offices for the District of South Carolina, the Southern District of California, the Northern District of Iowa, and the Eastern District of New York; the Department of Health and Human Services, Office of Counsel to the Inspector General and Office of Investigations; the Defense Criminal Investigative Service; the Defense Health Agency Office of General Counsel; the Federal Bureau of Investigation; and the National Association of Medicaid Fraud Control Units. The claims resolved by the settlement are allegations only, and there has been no determination of liability. The lawsuits resolved by this settlement are captioned United States, et al., ex rel. Ameer v. ResMed, Inc., et al., Case No. 2:15-CV-04842-MBS (D.S.C.); United States, et al., ex rel. Baker v. ResMed, Inc., et al., Case No. 3:16-CV-00987-MBS (D.S.C.); United States, et al., ex rel. Ross v. ResMed, Inc., Case No. 16-CV-1988-W (JLB) (S.D. Cal.); United States ex rel. Meyer v. ResMed, Inc., et al., Case No. 17-CV-12-MWB (N.D. Iowa); and United States, et al., ex rel. Ottavio, et al. v. ResMed, Inc., Case No. CV 17-5734 (E.D.N.Y.). U.S. Attorney Peter E. Deegan Jr. for the Northern District of Iowa also commented on the settlement, noting that, “Illegal kickbacks in the federal healthcare system create an unfair marketplace and the potential that medical decisions are not based on what is best for patients. This settlement is another sign of our office's dedication to fair and full enforcement of the False Claims Act.” “When companies give free equipment to doctors for the sole purpose of generating business and increasing their bottom lines, federal health insurance programs should not foot the bills. This case rights that alleged wrong by ResMed,” said U.S. Attorney Richard P. Donoghue for the Eastern District of New York. “We will continue to work with our law enforcement partners to hold accountable companies that put profits before patients.” Army Lt. Gen. Ron Place, Director of the Defense Health Agency also weighed in on the case, stating that, “I applaud the Department of Justice and the U.S. Attorneys' for their continued efforts to hold health care providers accountable to the American taxpayer. The efforts of the Department of Justice safeguard the health care benefit for our service members, veterans and their families. The Defense Health Agency continues to work closely with the Justice Department, and other state and federal agencies to investigate all those who participated in fraudulent practices.” Derrick L. Jackson, Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services, addressed both the settlement and the corporate integrity agreement. Mr. Jackson stated that, “The government contended ResMed provided free goods and services to companies in order to sell more medical equipment bought by taxpayers. The OIG's integrity [FN4] agreement with ResMed is designed to ensure such alleged behavior will not be repeated.” Founder of Insys receives 66-month prison sentence for alleged part in scheme to bribe doctors to prescribe fentanyl-based Subsys © 2021 Thomson Reuters. No claim to original U.S. Government Works. -3- The U.S. Justice Department recently announced that the founder of Insys Therapeutics, John Kapoor, was sentenced to 66 months in prison for allegedly orchestrating a scheme to bribe practitioners to prescribe Subsys, a fentanyl-based pain medication, often when medically unnecessary. John Kapoor, 76, of Phoenix, Ariz., was sentenced by U.S. District Court Judge Allison D. Burroughs to 66 months in prison, three years of supervised release, and ordered to pay forfeiture and restitution to be determined at a later date. The government recommended a sentence of 15 years in prison. Mr. Kapoor was convicted by a federal jury in May 2019 of racketeering conspiracy along with four other Insys executives. Kapoor, a veteran of the pharmaceutical industry, learned that he could profit from developing a spray delivery system for a generic drug, then marketing it as a premium product. Kapoor privately funded Insys as it developed Subsys, which was eventually approved to treat cancer patients suffering intense breakthrough pain. Because of significant personal financial investment, Kapoor was allegedly committed to ensuring that Insys was successful. He hired, or authorized the hiring of, several top executives who became co- conspirators in the criminal scheme to bribe practitioners. Many of these co-conspirators operated pain clinics to prescribe Subsys to patients, often when medically unnecessary. In 2012, Kapoor authorized the use of “speaker programs” purportedly intended to increase brand awareness of Subsys through peer- to-peer educational lunches and dinners. The programs, however, were allegedly used as a vehicle to pay bribes and kickbacks to targeted practitioners in exchange for increased Subsys prescriptions and increased dosage. Kapoor insisted that profits generated should double the amount of money spent paying doctors. In October 2012, Kapoor instructed the Vice President of Marketing to calculate the return on investment (ROI) for each speaker to determine if the speaker had a “positive ROI.” Practitioners who failed to meet satisfactory prescribing requirements were removed from the speaker program. Kapoor approved bribing doctors that he knew abusively prescribed opioids. Kapoor controlled the allegedly criminal scheme on a daily basis by conducting morning meetings, referred to as the “8:30 call,” which also involved many of his co-defendants. One of the topics discussed was the scheme to bribe doctors. Kapoor routinely discussed the suitability of additional funds, and which doctors were writing prescriptions for Subsys or a competitive drug. Kapoor was aware that the success of Insys depended on insurers approving payment for Subsys. In October 2012, Kapoor approved the creation of a pilot program, the “Insys Reimbursement Center” (IRC), which was dedicated to obtaining prior authorization for payment directly from insurers and pharmacy benefit managers. To do so, employees of the IRC posed as employees of the practitioner and used a script of false and misleading representations about patient diagnoses in order to secure approval for the drug by the insurance provider. For example, since insurers were more likely to authorize payment for Subsys if a patient was being treated for cancer-related pain, IRC employees were instructed to mislead insurers regarding the true diagnosis of the patient. Kapoor approved these tactics, and demanded a 100% success rate. United States Attorney Andrew E. Lelling commented on the sentence, noting that, “Out of pure greed, Insys executives, from John Kapoor on down, bribed doctors to prescribe this powerful and highly addictive narcotic to people who did not need it. Despite increasing public fears of a drug epidemic fueled by pain pill prescriptions, these defendants, led by Kapoor, ploughed ahead, setting weekly quotas for doctors on their payroll, urging them to prescribe Subsys in higher and higher doses, all so they could make millions of dollars at patients' expense.” Mr. Lelling further stated that, “Their disregard for the public's health and safety is nothing short of appalling. This case is not only about punishing these defendants. It is also about making the next pharmaceutical company think twice about its sales tactics and the basic corporate responsibility to not victimize the public. This was a landmark prosecution that successfully held accountable a pharmaceutical company's top executives for their roles in the illicit marketing and prescribing of opioids.” Joseph R. Bonavolonta, Special Agent in Charge of the FBI Boston Division, also commented on the case, stating that, “John Kapoor and his loyal lieutenants minimized their actions and distanced themselves from the harm they were committing on patients whose lives they ultimately ruined, and now all of them are finally being held accountable for their criminal conduct. Their downfall illustrates the FBI's commitment to attacking the ongoing opioid crisis from every angle, and we will continue to identify and dismantle criminal enterprises like this one to ensure those who are responsible for patient care are taking care of patients, and not themselves.” Phillip Coyne, Special Agent in Charge of the U.S Department of Health and Human Services, Office of the Inspector General, weighed in on the case as well, stating that, “These sentences undoubtedly send a clear message to health care executives relying on illegal schemes to increase profits: they will be held accountable for corporate crimes. The reckless and dangerous violation of law by these pharmaceutical executives is extremely serious, and we will not tolerate those who put profits above the well-being of patients. We will continue to attack the opioid crisis from all angles, including holding the pharmaceutical industry and its leadership accountable.” Judith McMeekin, Acting Associate Commissioner for Regulatory Affairs at the U.S. Food and Drug Administration, also commented that, “The FDA continues to respond forcefully to the ongoing opioid epidemic ? one of the largest public health tragedies our country has faced ? by ensuring the safe and appropriate use of these powerful medications. But bribing healthcare providers to prescribe this most powerful type of opioid ? an immediate release form of fentanyl ? is not only unacceptable, it puts patients at serious risk of overdose and potentially death. This conduct cannot be tolerated, and the FDA remains fully committed to working with our law [FN5] enforcement partners to bring to justice those who place profits before the public's health.” © 2021 Thomson Reuters. No claim to original U.S. Government Works. -4- Electronic health records vendor to pay $145 million to settle criminal and civil investigations; company admits to kickback scheme involving major opioid company The U.S. Department of Justice recently announced that Practice Fusion, Inc. (Practice Fusion), a San Francisco-based health information technology developer, will pay $145 million to resolve criminal and civil investigations relating to its electronic health records (EHR) software. As part of the criminal resolution, Practice Fusion admits that it solicited and received kickbacks from a major opioid company in exchange for utilizing its EHR software to influence physician prescribing of opioid pain medications. Practice Fusion has executed a deferred prosecution agreement and agreed to pay over $26 million in criminal fines and forfeiture. In separate civil settlements, Practice Fusion has also agreed to pay a total of approximately $118.6 million to the federal government and to states to resolve allegations that it accepted kickbacks from the opioid company and other pharmaceutical companies. The company was also accused of causing its users to submit false claims for federal incentive payments by misrepresenting the capabilities of its EHR software. Christina E. Nolan, United States Attorney for the District of Vermont, commented on the settlement, stating that, “Practice Fusion's conduct is abhorrent. During the height of the opioid crisis, the company took a million-dollar kickback to allow an opioid company to inject itself in the sacred doctor-patient relationship so that it could peddle even more of its highly addictive and dangerous opioids.” Ms. Nolan further noted that, “The companies illegally conspired to allow the drug company to have its thumb on the scale at precisely the moment a doctor was making incredibly intimate, personal, and important decisions about a patient's medical care, including the need for pain medication and prescription amounts. This recovery is commensurate to the nature of Practice Fusion's misconduct, represents the largest criminal fine in the history of this District, and requires Practice Fusion to admit to its wrongs. It is another example of pioneering healthcare fraud enforcement by the talented Assistant U.S. Attorneys and staff of this U.S. Attorney's Office, working with their partners in law enforcement. We cannot?and will not?tolerate technology companies influencing patient treatment merely because a pharmaceutical company provided a kickback.” The recently announced resolution addresses allegations that Practice Fusion extracted unlawful kickbacks from pharmaceutical companies in exchange for implementing clinical decision support (CDS) alerts in its EHR software, which were designed to increase prescriptions for their drug products. Specifically, in exchange for “sponsorship” payments from pharmaceutical companies, Practice Fusion allowed the companies to influence the development and implementation of the CDS alerts in ways aimed at increasing sales of the companies' products. Practice Fusion allegedly permitted pharmaceutical companies to participate in designing the CDS alert, including selecting the guidelines used to develop the alerts, setting the criteria that would determine when a healthcare provider received an alert, and in some cases, even drafting the language used in the alert itself. The CDS alerts that Practice Fusion agreed to implement did not always reflect accepted medical standards. In marketing this product to pharmaceutical companies, Practice Fusion emphasized the anticipated financial benefit to the pharmaceutical companies from increased sales of pharmaceutical products that would result from the CDS alerts. Between 2014 and 2019, health care providers using Practice Fusion's EHR software wrote several prescriptions after receiving CDS alerts that pharmaceutical companies participated in designing. Practice Fusion executed a deferred prosecution agreement with the U.S. Attorney's Office for the District of Vermont based on its solicitation and receipt of kickbacks from a major opioid company to arrange for an increase in prescriptions of extended release opioids by healthcare providers who used Practice Fusion's EHR software. Practice Fusion solicited a payment of nearly $1 million from the opioid company to create a CDS alert that would cause doctors to prescribe more extended release opioids. That payment was financed by the opioid company's marketing department, and the CDS was designed with input from the marketing department. Practice Fusion and the opioid company entered the CDS sponsorship because they believed that the CDS would influence doctors' prescriptions of extended release opioids. In marketing the “pain” CDS alert, Practice Fusion claimed that it would result in a favorable return on investment for the opioid company based on doctors prescribing more opioids. The criminal Information charges Practice Fusion with two felony counts for violating the Anti-Kickback Statute (AKS), 42 U.S.C. ? 1320a-7b(b)(1), and for conspiring with its opioid company client to violate the AKS, 18 U.S.C. ? 371. This case is the first ever criminal action against an EHR vendor. The Deferred Prosecution Agreement requires Practice Fusion to pay a criminal fine of $25,398,300 and forfeit criminal proceeds of nearly $1 million. Furthermore, the company agreed to cooperate in any ongoing investigations of the kickback arrangement and report any evidence of kickback violations by any other EHR vendors. The Deferred Prosecution Agreement also requires Practice Fusion to make documents relating to its unlawful conduct available to the public through a web site. The Deferred Prosecution Agreement also requires that Practice Fusion retain an independent oversight organization that is required to review and approve any sponsored CDS before Practice Fusion may implement the CDS, as well as create a comprehensive compliance program designed to ensure such abuses are not repeated. Principal Deputy Assistant Attorney General Ethan Davis of the Department of Justice's Civil Division noted that, “Across the country, physicians rely on electronic health records software to provide vital patient data and unbiased medical information during critical encounters with patients. Kickbacks from drug companies to software vendors that are designed to improperly influence the physician- © 2021 Thomson Reuters. No claim to original U.S. Government Works. -5- patient relationship are unacceptable. When a software vendor claims to be providing unbiased medical information ? especially information relating to the prescription of opioids ? we expect honesty and candor to the physicians making treatment decisions based on that information.” The civil settlement with the United States resolves Practice Fusion's potential civil liability arising from the submission of false claims to federal healthcare programs tainted by the kickback arrangement between Practice Fusion and the opioid company. It also resolves allegations of kickbacks relating to thirteen other CDS arrangements where Practice Fusion agreed with pharmaceutical companies to implement CDS alerts intended to increase sales of their products. The $118.6 million settlement amount includes approximately [FN6] $113.4 million to the federal government and up to $5.2 million to states that opt to participate in separate state agreements. Justice Department announces deferred criminal prosecution agreement with Sandoz over antitrust claims Sandoz Inc. (“Sandoz”), a generic pharmaceutical company headquartered in New Jersey, recently entered into a deferred prosecution agreement with the Department of Justice over antitrust allegations against the company. Sandoz was charged with conspiring to allocate customers, rig bids, and fix prices for generic drugs. A four-count felony charge was filed in the United States District Court for the Eastern District of Pennsylvania in Philadelphia, charging Sandoz with participating in four criminal antitrust conspiracies, each with a competing manufacturer of generic drugs and various individuals. The Antitrust Division also announced a deferred prosecution agreement (“DPA”) resolving the charges against Sandoz, under which the company agreed to pay a $195 million criminal penalty and admitted that its sales affected by the charged conspiracies exceeded $500 million. Under the deferred prosecution agreement, Sandoz has agreed to cooperate fully with the Antitrust Division's ongoing criminal investigation. As part of the agreement, the parties will file a joint motion, which is subject to approval by the Court, to defer for the term of the DPA any prosecution and trial of the charges filed against the defendant. This agreement represents the third pharmaceutical company to admit to criminal antitrust charges in the Antitrust Division's current ongoing investigation. The charged conspiracies took place between 2013 and 2015. According to Assistant Attorney General Makan Delrahim of the Department of Justice's Antitrust Division, “Today's resolution, with one of the largest manufacturers of generic drugs, is a significant step toward ensuring that prices for generic drugs are set by competition, not collusion, and rooting out antitrust crimes that cheated American purchasers of vital medicines.” Delrahim further noted that, “Sandoz conspired for years with other manufacturers and their executives to raise prices for critical medications, and the Antitrust Division will continue its ongoing investigation to hold both individuals and corporations accountable for these crimes.” In the deferred prosecution agreement, Sandoz admitted that it participated in the following charged antitrust conspiracies: • Count One charges Sandoz for its role in a conspiracy with a generic drug company based in New York and other individuals. Sandoz admitted that drugs affected by this conspiracy included clobetasol (cream, emollient cream, gel, ointment, and solution), desonide ointment, and nystatin triamcinolone cream. • Count Two charges Sandoz for its role in a conspiracy with Kavod Pharmaceuticals LLC (formerly known as Rising Pharmaceuticals) to allocate customers and fix prices of benazepril HCTZ. Rising was charged and entered into a deferred prosecution agreement in December 2019 for its participation in the same conspiracy. • Count Three charges Sandoz for its role in a conspiracy with a generic drug company based in Michigan. Sandoz admitted that drugs affected by this conspiracy included desonide ointment. • Count Four charges Sandoz for its role in a conspiracy with a generic drug company based in Pennsylvania. Sandoz admitted that drugs affected by this conspiracy included tobramycin inhalation solution. This case is the seventh to be filed in the Antitrust Division's ongoing investigation into the generic pharmaceutical industry. Sandoz is the third company to be charged, while the previous two companies also entered into deferred prosecution agreements. Four individual charges have been filed in the investigation. Three executives have pleaded guilty, including former Sandoz executive Hector Armando Kellum. Ara Aprahamian, a former executive of a company based in New York, was indicted in February 2020 and is awaiting trial. The charged offense carries a statutory maximum penalty of a $100 million fine per count for corporations, which may be increased to twice the gain derived from the crime or twice the loss suffered by victims if either amount is greater than $100 million. This charge is the result of an ongoing federal antitrust investigation into price fixing, bid rigging, and other anticompetitive conduct in the generic pharmaceutical industry, which is being conducted by the Antitrust Division with the assistance of the United States Postal Service Office of Inspector General, the FBI's Washington Field Office, the FBI's Philadelphia Field Office, and the U.S. Attorney's Office for the Eastern District of Pennsylvania. Special Agent in Charge Scott Pierce, U.S. Postal Service Office of Inspector General, commented on the case, stating that, “This significant resolution is a critical step toward ensuring a free and open marketplace for the competitive pricing of generic drugs. The outstanding work by the legal and investigative teams effectively quashed an environment of bid rigging, market allocation and price fixing within the generics industry. Along with our partners at the Department of Justice's Antitrust Division and the Federal Bureau © 2021 Thomson Reuters. No claim to original U.S. Government Works. -6- of Investigation, the U.S. Postal Service Office of Inspector General will continue to aggressively investigate this type of detrimental behavior.” Timothy M. Dunham, Special Agent in Charge of the FBI Washington Field Office's Criminal Division, also commented on the settlement, noting that, “This resolution demonstrates the continued dedication of the FBI and our partners to root out collusion and dishonest business practices within the pharmaceutical industry, on behalf of the American people. We will not turn a blind eye while companies and executives pad their pocketbooks. The FBI will continue to fight for the public to have access to a competitive marketplace of medications that Americans count on.” Furthermore, U.S. Attorney William M. McSwain for the Eastern District of Pennsylvania stated that, “When a pharmaceutical company participates in bid-rigging and price-fixing, the entire community suffers. My Office will continue to work with the Department of Justice and all of our law enforcement partners to ensure that prices for medicine are set legally, and not through illegal means to benefit pure [FN7] greed.” Pentax Medical Company settles charges with DOJ for $43 million; accused of shipping endoscopes without FDA approved instructions for use The Department of Justice recently announced that Pentax Medical Company will pay $43 million to resolve criminal charges based on the company's alleged shipment of four types of endoscopes for 18 months without FDA-cleared instructions for use. The federal government also contends that the company failed to file timely reports of two infections associated with its endoscopes. Pentax was charged in a criminal complaint in Newark federal court with distributing misbranded medical devices in interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). Pentax has entered into a three-year deferred prosecution agreement (DPA) that will allow it to avoid conviction if it complies with the reform and enhanced compliance requirements outlined in the agreement. As a result of the conduct outlined in the criminal complaint, Pentax has agreed to pay a $40 million criminal fine and to forfeit $3 million. As part of the DPA, Pentax has agreed to (among other actions) conduct a thorough audit of its current instructions for use for endoscopic devices and MDR procedures to determine their compliance with FDA requirements and report to the FDA in writing. The company has agreed to enhance its compliance training and maintain an effective compliance program. Pentax's president and the president of the Lifecare Division of Pentax's parent, Hoya Corporation, must annually certify that Pentax took the compliance measures required by the DPA, and Hoya's board of directors must certify annually that Pentax's compliance program is effective. According to Assistant Attorney General Jody Hunt of the Department of Justice's Civil Division, “In carrying out its responsibilities to protect the health and safety of patients treated with medical devices, the FDA relies on manufacturers to provide health care professionals with the correct, approved or cleared instructions for safe use of the devices, and to report promptly to the FDA potential product safety issues. Pentax's failure to follow important safety requirements is serious and warrants the significant penalties imposed as part of this resolution.” The criminal complaint against Pentax (which the company agrees is true) charges that the company made a deliberate business decision not to use revised FDA-cleared instructions for cleaning its endoscopes because Pentax feared the new instructions would cause it to lose business. Endoscopes are reusable devices that must be cleaned after each use or else infectious material may remain and be transmitted to subsequent patients. In 2014, the FDA told Pentax to revise its existing cleaning instructions for four types of endoscopes and add cleaning steps. Pentax agreed, and the FDA cleared, revised cleaning instructions in April 2014. Pentax was then required to include these revised cleaning instructions when it shipped those four endoscopes. Instead, for the next 18 months, Pentax shipped the four types of endoscopes with the old instructions for use. It did not include the newly enhanced, FDA-cleared cleaning instructions. Pentax decided not to use the enhanced cleaning instructions because they required customers to spend more time cleaning the endoscopes. One internal e-mail warned that the increase of cleaning time from five minutes to 25 minutes would be “catastrophic,” and another internal e-mail predicted that customers “will be very upset and could switch away from PENTAX because of the extra time, manpower, and cost to perform the new protocol.” Pentax continued shipping the four types of endoscopes without the FDA-cleared cleaning instructions until September 2015. At that time, Pentax started including FDA-cleared instructions for two of the endoscopes and newly validated cleaning instructions for the other two types of endoscopes. Pentax made $18 million in gross profits from selling the four types endoscopes during that 18-month period. Pentax was also charged with and admitted to failing to file timely reports of two infection incidents associated with its endoscope. The FDCA requires medical device manufacturers to file adverse event reports (referred to as Medical Device Reports (MDRs)) within 30 days of becoming aware of information that reasonably suggests that the manufacturer's device may have caused or contributed to a death or serious injury. In June 2013, Pentax learned that four patients at Advocate Lutheran General Hospital in Chicago were infected with drug-resistant bacteria after being treated with the same Pentax endoscope. Pentax failed to file MDRs within 30 days because its employees did not understand the reporting requirements. Pentax filed an MDR about the Advocate Lutheran infections in late September 2013. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -7- In late June 2014, Pentax learned that four patients at Massachusetts General Hospital in Boston were infected with Escherichia coli bacteria after being treated with the same Pentax endoscope. Pentax also failed to file MDRs about this incident within 30 days because its employees misunderstood the reporting requirements. Pentax filed an MDR about the infections at Massachusetts General Hospital in December 2014. U.S. Attorney Craig Carpenito for the District of New Jersey stated that, “Pentax made a decision to ignore the cleared instructions for use of its endoscopes, believing that doing so would increase its sales, putting profits over patient safety. In doing so, and by failing to report to the FDA certain adverse events relating to those endoscopes, it broke the law, jeopardized the health of patients, and, ultimately, cost itself $43 million on fines and forfeiture.” Catherine A. Hermsen, Assistant Commissioner for Criminal Investigations, FDA Office of Criminal Investigations, also commented the settlement. Ms. Hermsen noted that, “Americans expect and deserve that the medical devices used on them are safe, effective, and properly labeled with accurate information. When companies subvert FDA's standards and requirements, they place unsuspecting patients at risk. FDA will continue to investigate and help bring to justice companies that jeopardize the public health by distributing misbranded products.” The investigation was conducted by special agents from the FDA's Office of Criminal Investigations, under the direction of Special Agent in Charge Jeffrey J. Ebersole of the New York Field Office. Special agents of the U.S. Department of Health and Human Services, Office of Inspector General, under the direction of Special Agent in Charge Scott J. Lampert, also participated in the [FN8] investigation. Omnicare settles opioid-related charges with federal government for over $15 million The United States Attorney's Office for the Central District of California recently announced that Omnicare, Inc., a subsidiary of CVS Health and a provider of pharmacy services to long-term care facilities, has agreed to pay the United States a $15.3 million civil penalty to resolve allegations that it violated federal law by, among other actions, allowing opioids and other controlled substances to be dispensed without a valid prescription. The Cincinnati-based company operates “closed door” pharmacies (not open to the public) that deliver controlled substances to nursing homes and other long-term care facilities (LTCFs). Omnicare makes daily deliveries of prescription medications to residents of LTCFs, and it also pre-positions limited stockpiles of controlled substances at LTCFs in “emergency kits.” Emergency kits are to be dispensed to patients on an emergency basis. These emergency kits, which often include opioids and other controlled substances that are commonly abused and diverted, remain part of Omnicare's inventory and must be tightly controlled and tracked. The controlled substances may be dispensed only pursuant to a valid prescription. The United States alleged that Omnicare violated the federal Controlled Substances Act in its handling of emergency prescriptions, its controls over the emergency kits, and its processing of written prescriptions that lacked required elements such as the prescriber's signature or DEA number. The federal investigation found that Omnicare failed to control emergency kits by improperly permitting LTCFs to remove opioids and other controlled substances from emergency kits days before doctors provided a valid prescription. The investigation also revealed that Omnicare had repeated failures in its documentation and reporting of oral emergency prescriptions of Schedule II controlled substances. As part of the settlement, Omnicare agreed to pay a $15.3 million civil penalty and entered into a Memorandum of Agreement (MOA) with the Drug Enforcement Administration. The MOA will require Omnicare to increase its auditing and monitoring of emergency kits placed at LTCFs. According to United States Attorney Hanna, “Omnicare dispensed powerful opioids without valid prescriptions and failed to inform federal authorities of significant losses of opioids and other drugs. With the opioid crisis still a very real concern, every entity that handles dangerous drugs will be held accountable to ensure powerful narcotics are properly dispensed and not diverted to the black market.” DEA Acting Administrator Uttam Dhillon also commented on the settlement, stating that, “Omnicare failed in its responsibility to ensure proper controls of medications used to treat some of the most vulnerable among us. DEA is committed to keeping our communities safe by holding companies like Omnicare accountable for such failures, while ensuring continuity of care and necessary access to [FN9] emergency prescription drug supplies.” Generic drug maker Apotex settles criminal price fixing charges with DOJ for $24.1 million The Department of Justice recently announced that Apotex Corp., a generic pharmaceutical company headquartered in Florida, was charged with fixing the price of the generic drug pravastatin. According to the one-count felony charge filed in the U.S. District Court for the Eastern District of Pennsylvania in Philadelphia, Apotex and other generic drug companies agreed to increase and maintain the price of pravastatin, a commonly prescribed cholesterol medication that lowers the risk of heart disease and stroke. The conspiracy allegedly began in May 2013 and continued through December 2015. The Antitrust Division also announced a deferred prosecution agreement (DPA) resolving the charge against Apotex. The company agreed to pay a $24.1 million criminal penalty and admit that it conspired with other generic drug sellers to artificially raise the price of pravastatin. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -8- The single count alleges that Apotex communicated with competitors about the price increase and later refrained from submitting competitive bids to customers that previously purchased pravastatin from a competing company. Under the DPA, Apotex has agreed to cooperate fully with the Antitrust Division's ongoing criminal investigation. As part of the agreement, the parties will file a joint motion, which is subject to approval by the court, to defer for the term of the DPA any prosecution and trial of the charges filed against the defendant. The charged offense carries a statutory maximum penalty of a $100 million fine per count for corporations, which may be increased to twice the gain derived from the crime or twice the loss suffered by victims if either amount is greater than $100 million. Apotex is the fourth company to be charged in connection with antitrust violations in the generic pharmaceutical industry. The previous three corporate charges were resolved by deferred prosecution agreements. Four individuals have also been charged. Three entered guilty pleas and the fourth is awaiting trial. Assistant Attorney General of the Department of Justice Antitrust Division, Makan Delrahim, commented on the case, noting that, “Now, more than ever, we recognize and appreciate the importance of life-saving medications. When the makers of those medications conspire to raise prices for profit, the most vulnerable among us suffer. That's why we at the Antitrust Division are committed to pursuing the prosecution of antitrust crimes by the generic pharmaceutical industry.” Special Agent in Charge Scott Pierce, U.S. Postal Service Office of Inspector General, stated that, “During these difficult times, it is more important than ever that our pharmaceutical companies conduct business with the well-being of the consumer in mind. When generic drug companies conspire to fix prices and rig bids, they do so to the detriment of many who depend on these medications to maintain good health. Along with the Department of Justice Antitrust Division and our partners at the Federal Bureau of Investigation, the USPS Office of Inspector General will remain committed to investigating those who would engage in this type of harmful conduct.” Timothy R. Slater, Assistant Director in Charge of the FBI's Washington Field Office, also commented on the settlement, noting that, “Today's announcement demonstrates that the FBI is dedicated to enforcing the law and investigating those who choose to collude at the expense of innocent Americans. The public should not have to pay a higher price for necessary medications because of corporate greed. During these uncertain times, we know that access to life-saving medication is of the utmost importance. The FBI, along with our [FN10] partners, are focused on investigating and bringing those responsible to justice, on behalf of the American public.” Novartis settles False Claims Act allegations for $642 Million The U.S. Department of Justice recently announced that drug maker Novartis Pharmaceuticals Corporation, based in East Hanover, New Jersey, has agreed to pay over $642 million in separate settlements resolving claims that it violated the False Claims Act (FCA). The first settlement relates to the company's alleged illegal use of three foundations as conduits to pay the copayments of Medicare patients taking Novartis's drugs Gilenya and Afinitor. The second settlement resolves claims arising from the company's alleged payments of kickbacks to doctors. According to Jody Hunt of the Department of Justice's Civil Division “Through this settlement and others, the government has demonstrated its commitment to ensuring that drug companies do not use kickbacks to influence the drugs prescribed by doctors or purchased by patients. We will continue to safeguard the Medicare program from kickbacks and their pernicious effects, including the undermining of important cost-control mechanisms instituted by Congress.” The Anti-Kickback Statute prohibits anyone from offering or paying, directly or indirectly, any remuneration (including money or any other thing of value) to induce referrals of items or services covered by Medicare, Medicaid, and other federally funded programs. This prohibition applies to both improper payments to providers and improper payment of patients' copay obligations. In the first settlement, Novartis has agreed to pay $51.25 million to resolve allegations that it illegally paid the copay obligations for patients taking its drugs. When a Medicare beneficiary obtains a prescription drug covered by Medicare, the beneficiary may be required to make a partial payment, which may take the form of a copayment, coinsurance, or a deductible (collectively “copays”). Novartis sells Gilenya, which is approved for treatment of relapsing forms of multiple sclerosis (MS). The government alleged that, in October 2012, Novartis learned from the contractor managing Novartis's free drug program for Gilenya that over 300 patients who were receiving free drugs would be eligible for Medicare in 2013. Novartis and the contractor allegedly transitioned those patients to Medicare Part D so that Novartis would earn revenue from Medicare when those patients filled prescriptions for Gilenya. Knowing those patients could not afford the copay for Gilenya, Novartis developed a plan with a foundation so that Novartis could cover the copays for those patients. At the same time Novartis made a payment to the foundation, Novartis arranged for the foundation to open its MS fund at 6:00 pm on a Friday and for the contractor to have personnel working overtime to submit applications for those patients who had been receiving free Gilenya. Novartis allegedly knew that this coordination would result in a disproportionate share of its funding going to Gilenya patients for 2013. Novartis also markets Afinitor, which is a second-line treatment for advanced renal cell carcinoma (RCC) and a treatment for progressive neuroendocrine tumors of pancreatic origin (PNET). The government alleged that Novartis learned that, for the 2010 donation year, it would be the only donor to an RCC copay assistance fund operated by a charitable foundation. The government alleged that Novartis told the foundation that it would be willing to donate to the fund only if the eligibility definition was narrowed in a way that ensured that a greater amount of the copay assistance would support patients taking Afinitor. The government alleged that, as © 2021 Thomson Reuters. No claim to original U.S. Government Works. -9- a result of narrowing the fund definition, the fund disproportionately assisted patients taking Afinitor compared to its overall usage rate among RCC drugs. The government also alleged that, in 2012, Novartis asked another foundation to open a copay assistance fund to pay copays for PNET patients, which Novartis knew would be used only to pay the copays of Afinitor patients. In the second case, Novartis has agreed to pay $591,442,008 to resolve FCA claims that it paid kickbacks to doctors to induce them to prescribe the Novartis drugs Lotrel, Valturna, Starlix, Tekturna, Tekturna HCT, Tekamlo, Diovan, Diovan HCT, Exforge, and Exforge HCT. Novartis will also forfeit $38.4 million under the Civil Asset Forfeiture Statute. Novartis also made several factual admissions in the settlement and agreed to strict limitations on any future speaker programs, including reductions to the amount it may spend on such programs. In that case, which is pending in the Southern District of New York, the United States alleged that Novartis hosted tens of thousands of speaker programs and related events under the guise of providing educational content, when in fact the events served as nothing more than a means to provide bribes to doctors. Novartis paid physicians honoraria that was supposed to be compensation for delivering a lecture regarding a Novartis medication. However, as the company allegedly knew, many of these programs were social events held at expensive restaurants, with little or no discussion about the Novartis drugs. According to the federal government, some of the so-called speaker events never even took place, and the speaker was simply paid a fee in order to induce the speaker to prescribe Novartis drugs. Acting U.S. Attorney Audrey Strauss for the Southern District of New York noted that, “For more than a decade, Novartis spent hundreds of millions of dollars on so-called speaker programs, including speaking fees, exorbitant meals, and top-shelf alcohol that were nothing more than bribes to get doctors across the country to prescribe Novartis's drugs. Giving these cash payments and other lavish goodies interferes with the duty of doctors to choose the best treatment for their patients and increase drug costs for everyone. This office will continue to be vigilant in cracking down on kickbacks, however they may be dressed up, throughout the pharmaceutical industry.” The government's complaint also claimed that Novartis sales representatives, on the instruction of their managers, selected high- volume prescribers to serve as the paid “speakers” at these events with the intent to induce them to write more (or to keep writing) Novartis prescriptions. The sales representatives then pressured the speakers to increase their prescriptions of Novartis drugs, and often dropped doctors from the speaker program if they failed to do so. The government also alleged that this kickback scheme was the result of decisions made by top management at Novartis's North American headquarters in New Jersey. This settlement resolves a lawsuit initially filed under the whistleblower provision of the FCA, which permits private parties to file suit on behalf of the United States for false claims and share in a portion of the government's recovery. The amount to be recovered by the private whistleblower has not yet been determined. As part of the settlement, Novartis will also pay an additional $48,151,273 to resolve state Medicaid claims. Novartis also entered into a corporate integrity agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG). The five-year CIA addresses the alleged conduct at issue in both matters. The CIA requires Novartis to significantly reduce the number of paid speaker programs and the amounts spent on such programs. Under the CIA, Novartis speaker programs may only occur under limited circumstances and in a virtual format. The CIA also requires Novartis to implement measures designed to promote independence from any patient assistance programs to which it contributes. The CIA also requires extensive monitoring of Novartis's operations and obligates company executives and Board members to certify compliance. Gregory E. Demske, Chief Counsel to the Inspector General, HHS-OIG, stated that, “OIG will continue to work closely with the [FN11] Department of Justice to investigate and pursue kickbacks regardless of the form they take.” Alexion Pharmaceuticals settles with SEC and agrees to pay $21 million to resolve FCPA allegations The Securities and Exchange Commission recently announced that Boston-based pharmaceutical company Alexion Pharmaceuticals Inc. has agreed to pay more than $21 million to resolve charges that it violated the books and records and internal accounting controls provisions of the Foreign Corrupt Practices Act (FCPA). According to the SEC's order, two Alexion subsidiaries made payments to foreign government officials to secure favorable treatment for Alexion's primary drug, Soliris. The order finds that, from 2010 to 2015, Alexion Turkey paid Turkish government officials to improperly influence them to approve patient prescriptions and provide other favorable regulatory treatment for Soliris. The order also states that, from 2011 to 2015, Alexion Russia made improper payments to Russian government health care officials to favorably influence the regulatory treatment of and the budget allocated to Soliris, as well as to increase the number of approved Soliris prescriptions. Alexion Russia and Alexion Turkey allegedly maintained false books and records of these improper payments, which Alexion's internal accounting controls were not sufficient to detect or prevent. The order also finds that Alexion's subsidiaries in Brazil and Colombia failed to maintain accurate books and records, including by creating or directing third parties to create inaccurate financial records concerning payments to patient advocacy organizations. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -10- Alexion did not admit or deny the SEC's findings. It did agree to: (1) cease and desist from committing violations of the books and records and internal accounting controls provisions of the FCPA; (2) pay $14,210,194 in disgorgement; (3) pay $3,766,337 in prejudgment interest; and (4) pay a $3.5 million penalty. According to Melissa Hodgman, an Associate Director in the SEC's Division of Enforcement, “Alexion's internal accounting controls failed to detect and prevent payments to foreign government officials by its subsidiaries. Companies in frequent contact with foreign [FN12] officials need to ensure that their internal controls appropriately address such risks.” Mail order pharmacy settles dangerous dispensing claims with Massachusetts for $11 million Massachusetts Attorney General Maura Healey recently announced a $11 million settlement with an Andover, Massachusetts mail- order pharmacy resolving allegations that it failed to implement adequate safeguards against unlawful and dangerous dispensing. According to the state, the pharmacy's failures resulted in the shipment of thousands of potentially illegitimate controlled substance prescriptions across the country. In the complaint, which was filed along with a proposed consent judgment in Suffolk Superior Court, the Attorney General's Office alleges that Injured Workers Pharmacy (IWP) violated Massachusetts consumer protection law by failing to implement effective policies and procedures for reviewing prescriptions to determine whether they were legitimate and by engaging in unlawful marketing practices to drive sales, including paying law firms for patient referrals. According to Attorney General Healey “Injured Workers Pharmacy created an illegal operation that put dispensing speed and volume over patient and public safety. They dispensed thousands of prescriptions for dangerous drugs, including opioids like fentanyl, with a shocking lack of regard for whether those prescriptions were legitimate. Combatting the opioid epidemic remains a top priority of my office and we will aggressively pursue those who break our laws to profit from this crisis.” Healey's Office began investigating IWP, which serves thousands of workers' compensation patients nationwide, after learning that the pharmacy dispensed a high volume of controlled substances primarily to workers who had been injured on the job. The state's complaint alleges that IWP pressured pharmacists to dispense prescriptions faster and implemented programs that prioritized dispensing speed and volume over protecting its patients and preventing diversion. The complaint also alleges that IWP's dispensing and sales practices effectively precluded it from complying with statutory mandates and meeting its responsibility to fill only legitimate prescriptions issued in the usual course of professional treatment. According to the state's complaint, IWP also used unlawful tactics to drive sales, including entering into illegal agreements to buy patient referrals and incenting sales staff to engage in their own misconduct and ignore red flags by paying them based on dispensing volume. As a result of these unfair dispensing and sales practices, the complaint alleges IWP filled and shipped: • Thousands of prescriptions written by problem prescribers who were ultimately disciplined, indicted or convicted for improper opioid prescribing. IWP did not stop dispensing their prescriptions until long after their behaviors were or should have been apparent to pharmacy and sales staff; • Thousands of dangerous, high-dose prescriptions, including for fentanyl formulations known to be especially dangerous; and • Thousands of prescriptions for dangerous drug combinations known to be indicators of drug misuse and potential overdose, including the so-called “holy trinity” ? a combination of an opioid, a benzodiazepine, and a muscle relaxant. The proposed consent judgment, which requires court approval, would require IWP to undertake significant changes to its operations and business practices. The proposed consent judgment would require IWP to: • Hire a full-time Chief Compliance Officer to oversee IWP's compliance obligations, help assess whether to block and report prescribers, and design and administer training programs to teach IWP staff about red flag prescribing behaviors; • Hire a data analyst to review dispensing data to identify at-risk patients and suspicious prescribers; • Hire a pain management specialty pharmacist to counsel at-risk patients and their doctors to reduce the risks of those patients' treatment plans; • Undertake additional due diligence before dispensing certain initial high-risk prescriptions; • Consult state prescription drug monitoring programs prior to dispensing controlled substance prescriptions; • Offer to dispense naloxone to all patients receiving Schedule II and III controlled substances, including opioids, at no out-of-pocket cost to the patient; • Upgrade its dispensing software, including to enable pharmacists to see a prescriber's entire prescribing history; • Eliminate incentive compensation based on volume of controlled substance prescriptions dispensed; • Stop making unlawful payments for referrals; and • Hire an independent auditor approved by the AG's Office to conduct a one-year compliance audit. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -11- [FN13] The proposed judgment also requires IWP to pay $11 million to the Commonwealth of Massachusetts. Massachusetts files False Claims Act case against Mallinckrodt Massachusetts Attorney General Maura Healey recently announced that her office has filed a complaint under the Massachusetts False Claims Act against drug manufacturer Mallinckrodt ARD LLC for allegedly underpaying millions of dollars in rebates to the state's Medicaid program (MassHealth). Healey's office alleges that Mallinckrodt ARD LLC, previously known as Questcor Pharmaceuticals, knowingly underpaid rebates to MassHealth hospital through the Medicaid Drug Rebate Program for the medication Acthar Gel (Acthar). Under this program, when drug manufacturers raise drug prices beyond the rate of inflation they must pay quarterly rebates to Medicaid in exchange for Medicaid's coverage of the manufacturers' drugs. Attorney General Healey commented that, “Nearly two million people across the state rely on MassHealth to get critically important medical care, including prescription drugs like Acthar. It is inexcusable when drug companies like Mallinckrodt try to unlawfully boost their profits and shortchange residents who rely on MassHealth. We are filing this complaint to ensure this alleged behavior stops and to recover millions of dollars owed to our state.” According to the multi-state complaint filed today in the U.S. District Court for the District of Massachusetts (which was joined by 27 other states and territories), since 2013, Mallinckrodt allegedly has defrauded Massachusetts by falsely reporting the Base Date “Average Manufacturer Price” (or AMP) for Acthar. Massachusetts also alleges that Mallinckrodt had known since 2016 that it paid these lower rebates in defiance of requests for corrective action by the federal government. As a result of this conduct, the complaint alleges that Mallinckrodt failed to report and return hundreds of millions of dollars in overpayments to state Medicaid agencies nationwide. Acthar is used to treat a variety of conditions, including multiple sclerosis, psoriatic, rheumatoid arthritis, lupus, breathing disorders, and other inflammatory conditions. These allegations were originally made in a case filed in September 2018 under the whistleblower (or qui tam) provision of the False [FN14] Claims Act. DOJ files criminal charges against Teva The Department of Justice recently announced that Teva Pharmaceuticals USA Inc. has been charged with conspiring to fix prices, rig bids, and allocate customers for generic drugs. According to a superseding indictment filed in the U.S. District Court for the Eastern District of Pennsylvania, the company participated in three conspiracies from at least as early as May 2013 until at least in or around Dec. 2015. Count one charges Teva for its role in an alleged conspiracy that included Glenmark Pharmaceuticals Inc., USA (Glenmark), Apotex Corp. (Apotex), and others. On May 7, 2020, Apotex admitted to its role in this conspiracy and agreed to pay a $24.1 million penalty. On July 14, 2020, a grand jury returned an indictment against Glenmark for its role in the same conspiracy, which today's indictment supersedes. According to the charge, Teva, Glenmark, Apotex, and unnamed co-conspirators agreed to increase prices for pravastatin and other generic drugs. Pravastatin is a commonly prescribed cholesterol medication that lowers the risk of heart disease and stroke. Count two charges Teva for its role in an alleged conspiracy with Taro Pharmaceuticals U.S.A., Inc. (Taro U.S.A.), its former executive Ara Aprahamian, and others. On July 23, 2020, Taro U.S.A. admitted to its role in this conspiracy and agreed to pay a $205.7 million penalty to resolve that charge as well as its role in a separate antitrust conspiracy. Aprahamian was indicted in February 2020 for his role in the conspiracy with Teva, among other charges, and is awaiting trial. According to the charge, Teva and its co-conspirators agreed to increase prices, rig bids, and allocate customers for generic drugs including, but not limited to, drugs used to treat and manage arthritis, seizures, pain, skin conditions, and blood clots. Count three charges Teva for its role in an alleged conspiracy with Sandoz Inc. and others. In March 2020, Sandoz admitted to its role in this conspiracy, as well as in conspiracies with other generic drug manufacturers, and agreed to pay a $195 million penalty. According to the charge, Teva and its co-conspirators agreed to increase prices, rig bids, and allocate customers for generic drugs including, but not limited to, drugs used to treat brain cancer, cystic fibrosis, arthritis, and hypertension. According to Assistant Attorney General Makan Delrahim of the Department of Justice's Antitrust Division, “Today's charge reaffirms that no company is too big to be prosecuted for its role in conspiracies that led to substantially higher prices for generic drugs relied on by millions of Americans. The division will continue to work closely with our law enforcement partners to ensure that companies that blatantly cheat consumers of the benefits of free markets are prosecuted to the full extent of the law.” Teva is the seventh company to be charged for its participation in conspiracies to fix prices, rig bids, and allocate customers for generic drugs. Five previous corporate cases were resolved by deferred prosecution agreements, and Teva's co-conspirator Glenmark is awaiting trial. Four executives have also been charged. Three of those executives have entered guilty pleas, and one is awaiting trial. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -12- Each of the charged offenses carry a statutory maximum penalty of $100 million for the companies. The maximum fine may be increased to twice the gain derived from the crime, or twice the loss suffered by the victims of the crime if either amount is greater than $100 million. James A. Dawson, Acting Assistant Director in Charge of the FBI's Washington Field Office, also commented on the case. Mr. Dawson noted that, “Today's charges, the latest in a series of law enforcement actions taken against large drug companies, confirm that this kind of criminal behavior in the generic pharmaceutical industry will not be tolerated. Price fixing and bid rigging is a crime, and the American people?who rely on these drugs to treat serious ailments?are the ones who pay the price when companies like Teva conspire [FN15] to raise their costs. The FBI remains committed to holding companies accountable for their illegal and reprehensible activity.” California Insurance Commissioner settles California Insurance Frauds Prevention Act case against AbbVie Inc. California Insurance Commissioner Ricardo Lara recently announced a settlement agreement with AbbVie Inc. to resolve a lawsuit alleging violations of the California Insurance Frauds Prevention Act (Act) involving the marketing of the blockbuster prescription drug HUMIRA. AbbVie has agreed to reform its HUMIRA marketing practices in California, including disclosing that registered nurses employed as “Ambassadors” to interact with patients about HUMIRA are actually paid by the company, and are not a medical provider. The company has also agreed to reform how the drug is marketed to health care providers. AbbVie has also paid a combined $24 million to the State of California and the whistleblower who brought the case to the Department's attention. Commissioner Lara commented on the settlement, stating that, ‘AbbVie's prior practices in marketing HUMIRA egregiously put profits ahead of transparency in patient care and violated California law. This settlement delivers important reforms to AbbVie's business practices and a substantial monetary recovery that will be used to continue to combat insurance fraud.’ In October 2016, the Department of Insurance began an investigation into AbbVie after receiving a whistleblower case filed by a registered nurse who was employed as an AbbVie Ambassador in Florida. After its investigation, the Department intervened in that case and filed a Superseding Complaint alleging that whistleblower violated California's Insurance Frauds Prevention Act. The Department alleged that AbbVie violated the Act by unlawfully providing free and valuable professional goods and services to physicians to induce and reward AbbVie prescriptions. The Department also alleged that Nurse Ambassadors interfered with the flow of doctor-patient communications and did not directly answer questions pertaining to AbbVie marketing activities constituted kickbacks in violation of the Act, including the provision of meals and drinks to providers outside the context of speakers programs. AbbVie continues to deny the allegations. As part of the settlement, however, AbbVie agreed to reforms, including: • Ambassadors will disclose to patients that they are provided by AbbVie and do not work under the direction of the patient's health care provider. • The company will implement a policy modification prohibiting HUMIRA sales representatives from inviting HUMIRA prescribing health care providers to offsite business meals, except as part of the AbbVie speaker programs. • AbbVie will provide patients with the U.S. FDA-approved HUMIRA medication guide and Ambassadors will direct patients to the medication guide and their health care provider regarding side effects and safety risk. • The company will provide guidance and training that Ambassadors shall not have patient-specific discussions with providers who prescribe AbbVie. • AbbVie employees will be prohibited from describing Ambassadors to health care providers as “extensions of their offices” and from providing to providers any contact information for Ambassadors who interact with HUMIRA patients. [FN16] • AbbVie employees and Ambassadors will not actively participate in conversations between patients and insurance companies. Drug maker DUSA settles false claims allegations with Justice Department for $20.75 million The Department of Justice recently announced that Massachusetts-based DUSA Pharmaceuticals, Inc. (DUSA), a subsidiary of Sun Pharmaceutical Industries, Inc. (Sun Pharma), has agreed to pay the United States $20.75 million to resolve allegations that DUSA caused physicians to submit false claims to Medicare and the Federal Employee Health Benefit Program by knowingly promoting an administration process for the drug Levulan Kerastick that contradicted the product instructions approved by the U.S. Food and Drug Administration (FDA) and was unsupported by sufficient clinical evidence. Levulan Kerastick is a prescription topical solution approved by the FDA for the treatment of minimally to moderately thick actinic keratosis (AKs) of the face or scalp. At all relevant times, the “Dosage and Administration” section of the drug's FDA-approved instructions described a two-stage process involving application of the topical solution to the target lesions and then, following an incubation period of 14 to 18 hours, illumination of the target lesion with blue light. The United States alleged that, by January 2014, senior management at both DUSA and Sun Pharma knew that administration of Levulan Kerastick employing short incubation periods ranging from one to three hours resulted in AK clearance rates significantly lower than those achieved in clinical trials using 14 to 18-hour incubation. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -13- During the period of January 2014 through December 2016, DUSA allegedly encouraged physicians to use these less effective short incubation periods by using, among other things, paid physician speaker programs, paid physician peer-to-peer discussions, promotion by DUSA's sales force, and the dissemination of incomplete or misleading responses to questions from prescribing doctors. The government also claimed that DUSA failed to inform physicians that administering the drug using short incubation periods resulted in significantly lower AK clearance rates than achieved with the longer incubation period described in the FDA-approved instructions, and, in some cases, the company falsely stated that AK clearance rates were the same for the shorter and less effective incubation periods. As part of the settlement, DUSA and its parent company, Sun Pharma, have agreed to enter into a Corporate Integrity Agreement with HHS-OIG. That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter. The settlement with DUSA resolves a lawsuit filed under the whistleblower provision of the False Claims Act, which permits private parties to file suit on behalf of the United States for false claims and share in a portion of the government's recovery. The civil lawsuit was filed by Aaron Chung, who formerly worked for DUSA as a sales representative. As part of the resolution, Chung will receive approximately $3.5 million. According to Acting Assistant Attorney General Ethan P. Davis for the Justice Department's Civil Division “The department is committed to protecting taxpayer-supported health care programs from fraud and abuse. We will hold drug manufacturers accountable when they knowingly promote ineffective uses of their products that undermine patient care or waste program funds.” U.S. Attorney Brian T. Moran for the Western District of Washington also commented on the settlement, stating that, “While this scheme to provide false instructions on the use of its product may have resulted in more sales and bigger profits, it also meant customers endured the frustration of being repeatedly subjected to less effective treatments to try to get their skin lesions to clear. This investigation seeks to restore money to taxpayers and discourage those who put profits over effective treatment.” Special Agent in Charge Steven J. Ryan of the U.S. Department of Health and Human Services Office of Inspector General noted that, “Drug makers that push the inappropriate use of their products undermine the health of patients and the financial integrity of federal health care programs. Our oversight agency, working closely with our law enforcement partners, will continue to thoroughly investigate those who engage in such schemes.” Norbert E. Vint, Deputy Inspector General Performing the Duties of the Inspector General, Office of Personnel Management (OPM) OIG also commented on the case, stating that, “The OPM OIG will always seek to hold accountable those prioritizing profits over patient health and safety. This settlement demonstrates the commitment of our investigative staff and partners at the Department of Justice to combat health care fraud against the FEHBP.” The settlement with DUSA was the result of a coordinated effort among the U.S. Attorney's Office for the Western District of Washington and the Commercial Litigation Branch (Fraud Section) of the Justice Department's Civil Division, with assistance from HHS' [FN17] Office of Counsel to the Inspector General, FDA's Office of Chief Counsel, and HHS' Office of General Counsel. Justice Department reaches global resolution with Purdue Pharma and Sackler family over opioid-related claims The U.S. Department of Justice recently announced a global resolution of its criminal and civil investigations into the opioid manufacturer Purdue Pharma LP (Purdue), and a civil resolution of its civil investigation into individual shareholders from the Sackler family. The resolutions with Purdue are subject to the approval of the bankruptcy court. Purdue Pharma has agreed to plead guilty in federal court in New Jersey to a three-count felony information charging it with one count of dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act, and two counts of conspiracy to violate the Federal Anti-Kickback Statute. The criminal resolution includes the largest penalties ever levied against a pharmaceutical manufacturer, including a criminal fine of $3.544 billion and an additional $2 billion in criminal forfeiture. For the $2 billion forfeiture, the company will pay $225 million on the effective date of the bankruptcy, and, as further explained below, the department is willing to credit the value conferred by the company to State and local governments under the department's anti-piling on and coordination policy. Purdue has also agreed to a civil settlement in the amount of $2.8 billion to resolve its civil liability under the False Claims Act. Separately, the Sackler family has agreed to pay $225 million in damages to resolve its civil False Claims Act liability. According to Deputy Attorney General Jeffrey A. Rosen “The abuse and diversion of prescription opioids has contributed to a national tragedy of addiction and deaths, in addition to those caused by illicit street opioids. With criminal guilty pleas, a federal settlement of more than $8 billion, and the dissolution of a company and repurposing its assets entirely for the public's benefit, the resolution in today's announcement re-affirms that the Department of Justice will not relent in its multi-pronged efforts to combat the opioids crisis.” Steven M. D'Antuono, Assistant Director in Charge of the FBI Washington Field Office, also commented on the settlement. Mr. D'Antuono noted that, “Today's resolution is the result of years of hard work by the FBI and its partners to combat the opioid crisis in the U.S. Purdue, through greed and violation of the law, prioritized money over the health and well-being of patients. The FBI remains © 2021 Thomson Reuters. No claim to original U.S. Government Works. -14- committed to holding companies accountable for their illegal and inexcusable activity and to seeking justice, on behalf of the victims, for those who contributed to the opioid crisis.” The resolutions do not include the criminal release of any individuals, including members of the Sackler family. None of the company's executives or employees are receiving civil releases either. The global resolution with the company is subject to approval by the bankruptcy court in the Southern District of New York. One condition in the resolution is that the company would cease to operate in its current form and would instead emerge from bankruptcy as a public benefit company (PBC) owned by a trust or similar entity designed for the benefit of the American public, to function entirely in the public interest. According to the Department of Justice, “Indeed, not only will the PBC endeavor to deliver legitimate prescription drugs in a manner as safe as possible, but it will aim to donate, or provide steep discounts for, life-saving overdose rescue drugs and medically assisted treatment medications to communities, and the proceeds of the trust will be directed toward State and local opioid abatement programs.” Based on the value that would be conferred to State and local governments through the PBC, the department is willing to credit up to $1.775 billion against the agreed $2 billion forfeiture amount. As part of the criminal plea, Purdue will admit that from May 2007 through at least March 2017, the company conspired to defraud the United States by impeding the lawful function of the DEA by representing to the DEA that Purdue maintained an effective anti- diversion program. However, during this time, Purdue continued to market its opioid products to more than 100 health care providers whom the company had good reason to believe were diverting opioids and by reporting misleading information to the DEA to boost Purdue's manufacturing quotas. The misleading information comprised prescription data that included prescriptions written by doctors that Purdue had good reason to believe were engaged in diversion. The conspiracy also involved aiding and abetting violations of the Food, Drug, and Cosmetic Act by facilitating the dispensing of its opioid products, including OxyContin, without a legitimate medical purpose, and thus without lawful prescriptions. Purdue will also admit to conspiring to violate the Federal Anti-Kickback Statute. Between June 2009 and March 2017, Purdue made payments to two doctors through Purdue's doctor speaker program to induce those doctors to write more prescriptions of Purdue's opioid products. Similarly, from approximately April 2016 through December 2016, Purdue made payments to Practice Fusion Inc., an electronic health records company, in exchange for referring, recommending, and arranging for the ordering of Purdue's extended release opioid products such as OxyContin, Butrans, and Hysingla. The Justice Department's civil settlements resolve the United States' claims as to both Purdue and its individual shareholders, members of the Sackler family. The civil settlement with Purdue provides the United States with an allowed, unsubordinated, general unsecured bankruptcy claim for recovery of $2.8 billion. This settlement resolves allegations that from 2010 to 2018, Purdue caused false claims to be submitted to federal health care programs, specifically Medicare, Medicaid, TRICARE, the Federal Employees Health Benefits Program, and the Indian Health Service. The government claimed that Purdue promoted its opioid drugs to health care providers it knew were prescribing opioids for uses that were unsafe, ineffective, and medically unnecessary, and that often led to abuse and diversion. For example, Purdue learned that one doctor was known by patients as “the Candyman” and was prescribing “crazy dosing of OxyContin,” yet Purdue had sales representatives meet with the doctor more than 300 times. The civil settlements also resolve the government's allegations that Purdue engaged in three different kickback schemes to induce prescriptions of its opioids. First, Purdue allegedly paid certain doctors ostensibly to provide educational talks to other health care professionals and serve as consultants, but in reality to induce them to prescribe more OxyContin. Second, Purdue allegedly paid kickbacks to Practice Fusion, as described above. Third, Purdue allegedly entered into contracts with certain specialty pharmacies to fill prescriptions for Purdue's opioid drugs that other pharmacies had rejected as potentially lacking medical necessity. Under a separate civil settlement, individual members of the Sackler family will pay the United States $225 million arising from the [FN18] alleged conduct of Dr. Richard Sackler, David Sackler, Mortimer D.A. Sackler, Dr. Kathe Sackler, and Jonathan Sackler. III. General News Pharmaceutical trade organizations emphasize commitment to battling COVID-19 outbreak The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) recently publicly underscored the industry's commitment to finding solutions to prevent, diagnose, and treat those with COVID-19, a disease caused by a novel strain of coronavirus. According to a press release from both organizations, America's biopharmaceutical companies are “working around the clock” to: • Work with government agencies and diagnostic partners to increase COVID-19 testing capability and capacity; • Screen vast global libraries of medicines to identify potential treatments and have numerous clinical trials underway to test existing therapies; • Research and develop new therapies and treatments for those infected with the virus; and © 2021 Thomson Reuters. No claim to original U.S. Government Works. -15- • Use investments in new technologies to speed the development of safe and effective vaccines. According to Stephen J. Ubl, president and chief executive officer of PhRMA, “I'm confident our industry will achieve its shared goal to beat coronavirus, and our commitment underscores how we are uniquely positioned to do so.” Ubl further noted that, “We have deep scientific knowledge gained from decades of experience with similar viruses; the industry has invested billions in technologies that have dramatically shortened the time it takes to decode viruses and develop a potential vaccine; and our companies alone have the ability to manufacture and broadly disseminate vaccines or treatments.” Jim Greenwood, president and CEO of BIO, also commented on the COVID-19 situation, stating that, “Researchers at America's biopharmaceutical companies are working around the clock to contain the spread of the novel coronavirus and deliver treatments to those impacted by this deadly disease.” Greenwood also added that, “Today, we renew our commitment as an industry to help those in need, protect our workforce and ensure any treatments we develop in response to this pandemic are accessible and affordable for everyone. These are the principles that always guide our industry, and they serve as the foundation for our response to this global health crisis.” PhRMA represents many of the country's biopharmaceutical research companies. BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers, [FN19] and related organizations across the United States and in more than 30 other nations. PhRMA group president signs CEO Action for Diversity & Inclusion Pledge President and chief executive officer Stephen J. Ubl of the Pharmaceutical Research and Manufacturers of America (PhRMA) recently signed the CEO Action for Diversity & Inclusion Pledge. PhRMA joins over 900 businesses who have committed to this pledge. According to Mr. Ubl, “PhRMA has a unique ability to highlight our members' diversity and inclusion efforts and to help our industry learn from each other on how to build stronger, more diverse workforces. This pledge shows our commitment to diversity and inclusion ? both internally and in the biopharmaceutical industry ? which are essential to unlocking the scientific challenges that lead to new medicines and to helping the patients we serve.” The CEO Action Plan for Diversity & Inclusion Pledge includes four goals that PhRMA is working toward: • We will continue to make our workplace a trusting place to have complex, and sometimes difficult, conversations about diversity and inclusion; • We will expand unconscious bias education; • We will share best?and unsuccessful?practices; and • We will create and share strategic inclusion and diversity plans with our board of directors. PhRMA signed onto this pledge in tandem with work currently underway designed to celebrate diversity in its workforce and promote best practices across the industry. Some of these activities include: • Convening diversity and inclusion leaders from our member companies to share best practices. From designing clinical trials with diversity in mind to establishing employee resource groups to conducting internal research on diversity and inclusion, our companies are actively engaging on this issue. We will reconvene annually to share successes and challenges with each other. • Implementing a series of learning and development programs, including a course on inclusive leadership, that explore the concept of unconscious bias. PhRMA will continue to build on this effort in future programming to help employees identify blind spots and facilitate more open and honest conversations. • Promoting an LGBTQ-inclusive team. PhRMA has long worked toward this effort, including supporting the Equality Act, hosting an annual Pride reception in Washington, D.C., financially supporting the Human Rights Campaign's Healthcare Equality Index, and convening a health equity task force. Mr. Ubl further noted that, “The pledge allows us to expand our insights on diversity and inclusion work beyond our own member companies by learning from other CEOs who have signed the pledge. I look forward to deepening our understanding on this issue and [FN20] building an even more inclusive workplace.” Sanofi and GlaxoSmithKline announce collaboration to develop vaccine for COVID-19 Drug manufacturers Sanofi and GlaxoSmithKline (GSK) announced in April that they have signed a letter of intent to enter into a collaboration to develop an adjuvanted vaccine for COVID-19. The collaboration will use technology from both companies. Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology. This technology has produced an exact genetic match to proteins found on the surface of the virus, and the DNA sequence encoding this antigen has been combined into the DNA of the baculovirus expression platform, the basis of Sanofi's licensed recombinant influenza product in the US. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -16- GSK will contribute its proven pandemic adjuvant technology to the collaboration. The use of an adjuvant can be of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protect more people. Paul Hudson, Sanofi CEO, noted that, “As the world faces this unprecedented global health crisis, it is clear that no one company can go it alone. That is why Sanofi is continuing to complement its expertise and resources with our peers, such as GSK, with the goal to create and supply sufficient quantities of vaccines that will help stop this virus.” Emma Walmsley, GSK CEO, stated that “This collaboration brings two of the world's largest vaccines companies together. By combining our science and our technologies, we believe we can help accelerate the global effort to develop a vaccine to protect as many people as possible from COVID-19.” The companies plan to initiate phase I clinical trials in the second half of 2020 and, if successful and subject to regulatory considerations, aim to complete the development required for availability by the second half of 2021. Biomedical Advanced Research and Development Authority (BARDA) Director Rick A. Bright, Ph.D., commented on the partnership. Dr, Bright stated that, “Strategic alliances among vaccine industry leaders are essential to make a coronavirus vaccine available as soon as possible. Development of the adjuvanted recombinant-based COVID-19 vaccine candidate holds the potential to lower the vaccine dose to provide vaccine to a greater number of people to end this pandemic, and help the world become better prepared or even prevent future coronavirus outbreaks.” The companies have set up a Joint Collaboration Task Force, co-chaired by David Loew, Global Head of Vaccines, Sanofi and Roger Connor, President Vaccines, GSK. The taskforce will seek to utilize resources from both companies and search for every opportunity to accelerate the development of the potential vaccine. Both companies are “committed to making any vaccine that is developed through the collaboration affordable to the public and through [FN21] mechanisms that offer fair access for people in all countries.” Drug industry trade group discusses nearly 260 vaccines in pipeline, including 70 for COVID-19 The drug maker trade group PhRMA recently cited to a report that are 258 vaccines in development, including 70 vaccines for COVID-19. Among the vaccines in development are: • 108 vaccines for cancer, including a therapeutic vaccine for non-small cell lung cancer, which uses messenger RNA to mobilize the patient's own immune system to fight the tumor(s); • 125 vaccines for infectious diseases, including a vaccine designed to prevent HIV infection by teaching a patient's immune system to recognize and effectively fight the virus; • 14 vaccines for allergies, including vaccines that target peanut allergies; and • Two vaccines for Alzheimer's disease, including one therapeutic vaccine that targets amyloid beta protein, which is linked to the development of the neurological disorder Furthermore, several different types of potential vaccines are in development that target COVID-19. As of April 15, 2020, there were over 70 vaccines for COVID-19 in the global research pipeline. Six of these COVID-19 vaccines had entered human clinical trials, and several more are planning to begin human trials this year. An article from PhRMA stated that, “The rapid pace at which researchers have been able to advance COVID-19 vaccine candidates is a testament to the lessons learned from past vaccine R&D and strong partnerships across sectors. As biopharmaceutical companies seek to identify and develop potential vaccines against COVID-19, companies are already scaling up manufacturing capabilities at risk [FN22] and sharing technology platforms throughout the health care ecosystem.” New York announces Department of Financial Services proceedings against Mallinckrodt relating to opioid marketing New York Governor Andrew M. Cuomo recently announced that the New York State Department of Financial Services (DFS) has initiated administrative proceedings and filed charges against Mallinckrodt plc and its subsidiaries, Mallinckrodt LLC and SpecGX LLC. These charges are the first to be filed in DFS' ongoing investigation into the entities that allegedly created and perpetuated the opioid crisis. Governor Cuomo noted that, ‘The worst frauds are those that go beyond individual harm to institutionalized systemic fraud - and the opioid scheme is no exception. The opioid manufacturers knew how addictive and dangerous their products were and they used it as a business model for their own financial gain at the cost of thousands of human lives and billions of dollars. The damage they have caused by creating and perpetuating the opioid epidemic that is devastating our state and nation has been immeasurable, and we are taking action to ensure these big pharmaceutical companies are held responsible for their fraudulent practices.’ According to DFS' Statement of Charges, Mallinckrodt was the “most prolific” manufacturer of opioid pills in the New York market. It produced approximately 39 percent of the opioid pills that flooded New York from 2006 to 2014. From 2009 to 2019, Mallinckrodt © 2021 Thomson Reuters. No claim to original U.S. Government Works. -17- supplied New York policyholders of commercial health insurance, which amounts to approximately five million people, with over one billion opioid pills. The DFS Statement of Charges alleges that Mallinckrodt: • Misrepresented the safety and efficacy of both its branded and unbranded opioid products in an effort to convince healthcare professionals and patients, falsely, that the benefits of using opioids to treat chronic pain outweighed the risks and that opioids could be safely used by chronic pain patients; • Repeatedly overstated the benefits of long-term opioid treatment and failed to disclose the lack of evidence supporting such use; • Downplayed the risks of negative outcomes for patients, including the risk of addiction and abuse and the difficulty of withdrawal; and falsely masked the signs of addiction by calling them ‘pseudo-addiction’; and • Knew the false narrative and misrepresentations would result in claims for payment of medically unnecessary opioid prescriptions to commercial insurance companies. DFS alleges that Mallinckrodt made misrepresentations in several materials and by various means, including in the labeling and marketing of its branded opioids; in online educational materials directed towards both prescribers and patients; in materials published by Front Groups, seemingly independent third-parties that were in effect controlled by Mallinckrodt and others in the opioid industry; and in scholarly materials and textbooks used for training prescribing physicians. The state claims that Mallinckrodt knew that the statements it was presenting as proven scientific facts were fraudulent with no scientific basis. According to DFS' Statement of Charges, Mallinckrodt violated two New York Insurance Laws. The first is Section 403 of the New York Insurance Law, which prohibits fraudulent insurance acts and carries with it penalties of up to $5,000 plus the amount of the fraudulent claim for each violation. DFS argues that each fraudulent prescription constitutes a separate violation. The second law the company is accused of violating is Section 408 of the Financial Services Law, which prohibits intentional fraud or intentional misrepresentation of a material fact with respect to a financial product or service (including health insurance). This law includes penalties of up to $5,000 per violation, and DFS contends that each fraudulent prescription constitutes a separate violation. [FN23] The hearing will be held at the office of the New York State Department of Financial Services in August 2020. International biopharmaceutical organization discusses industry obligations in light of search for COVID-19 vaccine The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) recently provided a media update on the biopharmaceutical industry's efforts to increase research and development for a new COVID-19 vaccine. The organization also noted that plans are underway to scale up manufacturing at risk even though it is not sure yet which, if any, vaccines in development will be found to be safe and effective. According to the IFPMA, such investment decisions are “unprecedented” and demonstrate that companies are not taking a “business as usual” approach in their response to the global pandemic. The industry reaffirmed its awareness of its responsibility towards patients and society to use its knowledge and expertise, in collaboration with others, in finding a coronavirus vaccine that is safe and effective. As of May 27, 2020, the WHO reported there are currently ten candidate vaccines in clinical evaluation and 115 candidate vaccines in pre-clinical evaluation. Several biopharmaceutical companies are researching vaccine candidates and are collaborating in the sharing of existing technologies. These shared technologies are intended to allow a rapid upscale of production once a vaccine candidate is identified. Companies are also sharing technologies that act as an adjuvant, which can boost the effectiveness of a potential vaccine. Thomas Cueni, IFPMA Director General, noted that, “Not only does the science have to be on our side if we are to quickly find a coronavirus vaccine, but we also have to find ways of being able to produce hundreds of millions, possible billions of doses of the new vaccine. Then people need to be vaccinated in sufficient numbers to protect whole communities. And, all the while, we should continue to produce existing vaccines.” Mr. Cueni also stated that, “The only way to deliver on our promise of safe, equitable, affordable coronavirus vaccines is for science and collaboration on a global scale to prevail. Be in no doubt, our member companies are fully engaged in the race to find a vaccine. We are fully committed to playing our full role within existing partnerships, such as ACT Accelerator and Gavi, on the basis that we [FN24] wholeheartedly embrace the goal of providing new coronavirus vaccines for all.” Food and drug organizations issue joint statement relating to signature-free delivery or pick-up of prescription drugs during COVID-19 pandemic The Food Industry Association, the National Association of Chain Drug Stores (NACDS), National Community Pharmacists Association (NCPA), National Grocers Association (NGA), and the Pharmaceutical Care Management Association (PCMA) recently issued a joint statement outlining the best practices for pharmacies and pharmacy benefit managers (PBMs) to follow for documenting signature-free delivery or pick-up of prescription drugs during the COVID-19 pandemic. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -18- These best practices are intended “to provide clarity so that consumers can feel confident in not having to physically sign for their prescriptions and to address pharmacy concerns about proper documentation for future audits.” According to the statement, as long as one of the following is included in the delivery documentation, such documentation should be sufficient in the event of an audit: • The delivery date, time, and words “COVID delivery” in the signature line; • The delivery date, time, and word “COVID” in the signature line; or • The delivery date, time, and word “COVID-19” in the signature line. According to Leslie Sarasin, President and CEO, Food Marketing Institute (FMI), “In an effort to minimize the spread of the COVID-19 virus, FMI appreciates the opportunity to collaborate with PCMA and the pharmacy trade associations to streamline transactions and facilitate a more consistent touchless customer experience regardless of whether the transaction is conducted in pharmacy, via mail order, curbside pickup or delivery.” NCPA CEO B. Douglas Hoey also commented on the statement, noting that, “The 20,000 plus community pharmacies have courageously worked on the front line as essential businesses to make sure consumers had access to their prescription medications and other supplies needed to stay safe and healthy including reconfiguring their pharmacy operations to provide contactless delivery of medications.” Mr. Hoey also noted that, “We appreciate consistent guidance from PBMs in this matter to help assure that pharmacists can focus on their most important job ? taking care of patients.” Steven C. Anderson, President and CEO, NACDS, noted that, “Since the outset of COVID-19, NACDS has urged public policy that helps to keep pharmacies open, to protect pharmacy customers and staff, to help patients stay on their medication therapies, and to help meet the needs of those affected by COVID-19 and by other illnesses. These collaborative principles support those goals, and they will benefit patients in this next phase of protecting public health and reopening our communities.” JC Scott, President and CEO, PCMA, also commented on the letter, stating that, “We have appreciated the strong collaboration with our trade association partners on this issue of critical importance to patients seeking safe access to their prescription drugs. Open dialogue among stakeholders in the prescription drug supply and payment chain has been essential during the COVID-19 pandemic. We look forward to continuing to work together in the best interest of the patients we serve.” “On behalf of the over 3,000 independent grocery pharmacies across the country, the National Grocers Association is committed to working with a coalition of stakeholders to protect the health of patients and provide transparency for pharmacies as they continue to serve their communities during this COVID-19 pandemic,” said Greg Ferrara, President and CEO, NGA. “NGA is encouraged by these [FN25] best practices and we hope that continued collaboration with all organizations involved will lead to better outcomes for patients.” CEOs of potential COVID-19 vaccine makers pledge to “Stand with Science” The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline plc, Johnson & Johnson, Merck, Moderna, Inc., Novavax, Inc., Pfizer Inc., and Sanofi recently announced a pledge outlining a “united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.” All nine CEOs signed the following pledge: We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles. The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA's guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to: • Always make the safety and well-being of vaccinated individuals our top priority. • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes. • Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA. • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -19- We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines [FN26] are evaluated and may ultimately be approved. Bipartisan group of Senators calls for enforcement action against drug makers relating to 340B Drug Pricing Program during COVID-19 pandemic U.S. Senator Tammy Baldwin (D-WI), a member of the Senate Committee on Health, Education, Labor and Pensions (HELP), is leading a bipartisan group of lawmakers in calling for enforcement action to address practices of pharmaceutical companies that, according to Senator Baldwin, threaten to undermine the 340B Drug Pricing Program during the COVID-19 public health emergency. The 340B program requires drug companies to sell discounted prescription drugs to safety net hospitals, rural health facilities, and other entities that provide care in underserved communities. Savings from the 340B program ensure that these “covered entities” are able to continue to serve their patients. Baldwin and her colleagues contend that drug makers have recently announced new burdensome requirements on covered entities beyond the scope of the 340B program, or they have announced that they will no longer provide discounts for medications shipped to pharmacies that dispense drugs to patients on behalf of covered entities. In their letter to Health and Human Services Secretary Alex Azar, the bipartisan group of Senators urged the administration to take immediate enforcement action to stop these tactics and ensure safety-net providers are able to continue providing life-saving medications to patients across the country. The Senators wrote, “In the midst of the ongoing COVID-19 pandemic, where providers have seen drops in revenue and available resources, it is critically important that 340B covered entities, including federally qualified health centers (FQHCs), FQHC Look-Alikes, children's hospitals, Ryan White HIV/AIDS clinics, and other safety-net hospitals and providers are able to continue to serve the individuals who seek out their care. As these threats to the Program progress, we fear the potential exacerbation of these shortfalls in resources for providers at a time when they are needed most.” This bipartisan effort is supported by the American Hospital Association (AHA), America's Essential Hospitals, American Association of Medical Colleges (AAMC), 340B Health, Ascension Wisconsin, Children's Wisconsin, Marshfield Health System, Gunderson Health System, Advocate Aurora, Rural Wisconsin Health Cooperative, and Sixteenth Street Community Health Centers in Milwaukee. According to Tom Nickels, AHA Executive Vice President, “The AHA thanks this bipartisan group of senators for their important effort to protect the 340B program, and the vulnerable communities it benefits, from big drug companies' efforts to harm the program. The AHA continues to call on the Department of Health and Human Services to take action against drug companies and to protect the patients and communities the 340B program helps serve.” Bruce Siegel MD, MPH, President and CEO of America's Essential Hospitals, also commented on the letter. Dr. Siegel stated that, “Drug manufacturers are flouting their statutory obligations by restricting access to safe, affordable medications for low-income Americans who also are among those most affected by COVID-19. We applaud the bipartisan Senate signatories, led by Sens. Baldwin, Thune, Stabenow, Portman, Cardin, and Capito, for their swift action to urge the administration to stop big pharma's ill-timed and illegal efforts to narrow the 340B program.” Karen Fisher, JD, Chief Public Policy Officer of the Association of American Medical Colleges, noted that, “The AAMC appreciates Senators from both sides of the aisle working together to protect the 340B program and patients. Fisher further stated that, “Particularly in the midst of the COVID-19 pandemic, it is unwarranted that several major drug companies are attempting to undermine this important program that allows safety net hospitals, including many teaching hospitals, to provide critical health care services to vulnerable patients in communities across the country.” The letter to Secretary Azar also stated in part, “While we understand that the Health Resources and Services Administration (HRSA) is further investigating these actions, we urge HRSA to take immediate and appropriate enforcement action to halt these tactics and ensure safety-net providers are able to continue providing life-saving medications to patients across the country.” The Senators then focused on drug makers Eli Lilly and AstraZeneca. “As you are aware, on September 1, 2020, Eli Lilly announced that the company would no longer allow 340B covered entities to receive discounts for products that are shipped to a contract pharmacy, with an exception for insulin. This follows similar actions from AstraZeneca, which announced in August that it would refuse 340B pricing to hospitals with on-site pharmacies for any drugs dispensed through contract pharmacies. Similarly, other companies have imposed additional and burdensome reporting requirements on all contract pharmacy claims. For covered entities, and in particular rural hospitals and other rural covered entities that rely disproportionately on contract pharmacies, these changes could have long-lasting repercussions that will challenge a covered entity's ability to support its community now during this pandemic and in the future.” The Senators also stated in the letter that, “To ensure pharmaceutical manufacturers continue to comply with the 340B statute and provide discounts to safety-net providers, we call on HRSA to take appropriate, prompt enforcement action to address violations of the Public Health Service Act. We appreciate your attention to this important issue and look forward to partnering with you and stakeholders to ensure the 340B program continues to support access to quality health services with proper oversight and transparency.” © 2021 Thomson Reuters. No claim to original U.S. Government Works. -20- The bipartisan letter was also signed by the following Senators: Rob Portman (R-OH), Debbie Stabenow (D-MI), Shelley Moore Capito (R-WV), John Thune (R-SD), Ben Cardin (D-MD), Patty Murray (D-WA), Susan Collins (R-ME), Ron Wyden (D-OR), Jerry Moran (R- KS), Jon Tester (D-MT), Mike Rounds (R-SD), Doug Jones (D-AL), Joni Ernst (R-IA), Gary Peters (D-MI), John Boozman (R-AR), Bob Casey (D-PA), Cindy Hyde-Smith (R-MS), Mark Warner (D-VA), Roger Wicker (R-MS), Angus King (I-ME), Kevin Cramer (R-ND), Chuck Schumer (D-NY), Thom Tillis (R-NC), Chris Van Hollen (D-MD), Elizabeth Warren (D-MA), Sherrod Brown (D-OH), and Kirsten Gillibrand (D-NY). Maureen Testoni, President and CEO of 340B Health, noted that, “340B has a long history of bipartisan support in Congress. Drug companies must stop denying discounts on expensive outpatient drugs in violation of the 340B statute. We appreciate the efforts of [FN27] these Senate leaders in making that message crystal clear.” Pfizer and Biontech announce vaccine candidate against COVID-19; potential 90% efficacy rate Pfizer Inc. and BioNTech SE recently announced that their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection. This conclusion was based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study. After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at seven days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide. According to Dr. Albert Bourla, Pfizer Chairman and CEO, “Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19. We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today's news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.” After discussions with the FDA, the companies recently decided to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at seven days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a two-dose schedule. As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide. Mr. Bourla further noted that, “I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavor. We could not have come this far without the tremendous commitment of everyone involved.” Professor Ugur Sahin, BioNTech co-founder and CEO, also commented on the announcement. Sahin noted that, “The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort.” Sahin also added that, “When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.” The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020. Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -21- In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from seven days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well. The companies believe that the addition of these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learnings and comparisons between these novel vaccine platforms. The companies have posted an updated version of the study protocol at https://www.pfizer.com/science/coronavirus. Pfizer and BioNTech continue to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate will be available by the third week of November. Two months is the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization A. Participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose. Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced. Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021. [FN28] Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication. © Copyright Thomson/West - NETSCAN's Health Policy Tracking Service [FN2] . “Attorney General Hunter Announces Settlement with Endo Pharmaceuticals for Company's Alleged Role in State Opioid Crisis,” January 10, 2020, available at: http://www.oag.ok.gov/attorney-general-hunter. [FN3] . “Breaking Legal News: TEVA Agrees to Pay $54 Million to Settle McEldrew Young False Claims Act Qui Tam Whistleblower Lawsuit,” January 6, 2020, available at: https://www.prnewswire.com/news-releases/breaking-legal-news-teva-agrees-to-pay-54-million-to-settle- mceldrew-young-false-claims-act-qui-tam-whistleblower-lawsuit-300981790.html. [FN4] . “Resmed Corp. to Pay the United States $37.5 Million for Allegedly Causing False Claims Related to the Sale of Equipment for Sleep Apnea and Other Sleep-Related Disorders,” January 15, 2020, available at: https://www.justice.gov/opa/pr/resmed-corp-pay-united- states-375-million-allegedly-causing-false-claims-related-sale. [FN5] . “Founder and Former Chairman of the Board of Insys Therapeutics Sentenced to 66 Months in Prison,” January 23, 2020, available at: https://www.justice.gov/usao-ma/pr/founder-and-former-chairman-board-insys-therapeutics-sentenced-66-months-prison. [FN6] . “Electronic Health Records Vendor to Pay $145 Million to Resolve Criminal and Civil Investigations,” January 27, 2020, available at: https://www.justice.gov/opa/pr/electronic-health-records-vendor-pay-145-million-resolve-criminal-and-civil-investigations-0. [FN7] . “Major Generic Pharmaceutical Company Admits to Antitrust Crimes,” March 2, 2020, available at: https://www.justice.gov/opa/pr/major-generic-pharmaceutical-company-admits-antitrust-crimes? fbclid=IwAR2Mt9EDzB1Fx6zxgVkHWzQv_QH45h7ogA4AHhfkwXJKtV7Ok9fa9DoKpkI. [FN8] . “Pentax Medical Company Agrees to Pay $43 Million to Resolve Criminal Investigation Concerning Misbranded Endoscopes,” April 7, 2020, available at: https://www.justice.gov/opa/pr/pentax-medical-company-agrees-pay-43-million-resolve-criminal-investigation- concerning. [FN9] . “Omnicare Agrees to Pay Over $15 Million to Resolve Allegations It Improperly Dispensed Opioids at Long-Term Care Facilities,” May 13, 2020, available at: https://www.justice.gov/usao-cdca/pr/omnicare-agrees-pay-over-15-million-resolve-allegations-it-improperly- dispensed-opioids. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -22- [FN10] . “Generic Pharmaceutical Company Admits to Fixing Price of Widely Used Cholesterol Medication,” May 7, 2020, available at: https:// www.justice.gov/opa/pr/generic-pharmaceutical-company-admits-fixing-price-widely-used-cholesterol-medication. [FN11] . “Novartis Pays Over $642 Million to Settle Allegations of Improper Payments to Patients and Physicians,” July 1, 2020, available at: https://www.justice.gov/opa/pr/novartis-pays-over-642-million-settle-allegations-improper-payments-patients-and-physicians. [FN12] . “SEC Charges Alexion Pharmaceuticals With FCPA Violations,” July 2, 2020, available at: https://www.sec.gov/news/press- release/2020-149. [FN13] . “AG Healey Secures $11 Million Settlement with Andover Mail-Order Pharmacy for Illegal Dispensing and Sales Tactics,” June 25, 2020, available at: https://www.mass.gov/news/ag-healey-secures-11-million-settlement-with-andover-mail-order-pharmacy-for-illegal. [FN14] . “AG Healey Intervenes in Whistleblower False Claims Act Case Against Major Drug Company,” July 16, 2020, available at: https:// www.mass.gov/news/ag-healey-intervenes-in-whistleblower-false-claims-act-case-against-major-drug-company. [FN15] . “Seventh Generic Drug Manufacturer Is Charged In Ongoing Criminal Antitrust Investigation,” August 25, 2020, available at: https:// www.justice.gov/opa/pr/seventh-generic-drug-manufacturer-charged-ongoing-criminal-antitrust-investigation. [FN16] . “California Department of Insurance fraud lawsuit results in reforms of HUMIRA marketing and $24 million payment by drugmaker AbbVie,” August 6, 2020, available at: http://www.insurance.ca.gov/0400-news/0100-press-releases/2020/release071-2020.cfm. [FN17] . “DUSA Pharmaceuticals To Pay U.S. $20.75 Million To Settle False Claims Act Allegations Relating To Promotion Of Unsupported Drug Administration Process,” August 24, 2020, available at: https://www.justice.gov/opa/pr/dusa-pharmaceuticals-pay-us-2075-million- settle-false-claims-act-allegations-relating. [FN18] . “Justice Department Announces Global Resolution of Criminal and Civil Investigations with Opioid Manufacturer Purdue Pharma and Civil Settlement with Members of the Sackler Family,” October 21, 2020, available at: https://www.justice.gov/opa/pr/justice-department- announces-global-resolution-criminal-and-civil-investigations-opioid. [FN19] . “America's Biopharmaceutical Companies Working Around the Clock to Beat Coronavirus,” March 20, 2020, available at: https:// phrma.org/Press-Release/Americas-Biopharmaceutical-Companies-Working-Around-the-Clock-to-Beat-Coronavirus. [FN20] . “PhRMA Joins CEO Action Plan for Diversity and Inclusion? Pledge,” March 2, 2020, available at: https://phrma.org/Press-Release/ PhRMA-Joins-CEO-Action-Plan-for-Diversity-and-Inclusion-Pledge. [FN21] . “Sanofi and GSK to join forces in unprecedented vaccine collaboration to fight COVID-19,” April 14, 2020, available at: https:// www.gsk.com/en-gb/media/press-releases/sanofi-and-gsk-to-join-forces-in-unprecedented-vaccine-collaboration-to-fight-covid-19/. [FN22] . Andrew Powaleny, “New report shows nearly 260 vaccines in development, including dozens for COVID-19,” April 23, 2020, available at: https://catalyst.phrma.org/new-report-shows-nearly-260-vaccines-in-development-including-dozens-for-covid-19. [FN23] . “Governor Cuomo Announces First Insurance Fraud Action Against Major Opioid Manufacturer In New York Market,” April 21, 2020, available at: https://www.dfs.ny.gov/press_releases/pr202004212. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -23- [FN24] . “Pharma partners in efforts to give coronavirus vaccine for everyone,” May 28, 2020, available at: https://www.ifpma.org/resource- centre/pharma-partners-in-efforts-to-give-coronavirus-vaccine-for-everyone/. [FN25] . “FMI, NACDS, NCPA, NGA and PCMA announce best practices for signature-free access to prescription drugs,” June 22, 2020, available at: https://www.pcmanet.org/fmi-nacds-ncpa-nga-and-pcma-announce-best-practices-for-signature-free-access-to- prescription-drugs/. [FN26] . “Biopharma Leaders Unite to Stand with Science,” September 9, 2020, available at: https://investors.modernatx.com/news-releases/ news-release-details/biopharma-leaders-unite-stand-science. [FN27] . “Senator Baldwin Leads Bipartisan Effort in Urging Action to Address Practices of Pharmaceutical Companies Undermining 340b Program,” September 17, 2020, available at: https://www.baldwin.senate.gov/press-releases/pharmaceutical-companies- undermining-340b-program. [FN28] . “Pfizer and Biontech announce vaccine candidate against COVID-19 achieved success in first interim analysis from Phase 3 study,” November 9, 2020, available at: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce- vaccine-candidate-against. Produced by Thomson Reuters Accelus Regulatory Intelligence 14-Mar-2021 © 2021 Thomson Reuters. No claim to original U.S. Government Works. -24-