Generic drugs: Stakeholder views on improving FDA’s information on patents : report to congressional committees

Generic drugs: Stakeholder views on improving FDA’s information on patents : report to congressional committees

Collection:
Health Policy and Services Research
Alternate Title(s):
Stakeholder views on improving FDA’s information on patents: report to congressional committees
Contributor(s):
United States. Government Accountability Office, issuing body.
Publication:
Washington, DC : United States Government Accountability Office, March 2023
Language(s):
English
Format:
Text
Subject(s):
Drugs, Generic -- economics
Drug Development -- legislation & jurisprudence
Government Regulation
Legislation, Medical
Patents as Topic -- legislation & jurisprudence
Prescription Fees -- legislation & jurisprudence
United States
Genre(s):
Technical Report
Abstract:
Why GAO did this study. The process of developing and bringing a new drug to the market can be long and costly. Patent protections for new drugs provide opportunities for drug sponsors to recoup their costs by limiting competition for specified periods of time. While these protections can encourage research and development into innovative therapies, they can also increase costs for consumers and health insurers by keeping cheaper alternatives off the market. The U.S. has established policies to provide incentives to develop new brand name drugs while also creating opportunities for other companies to manufacture generic products, which are generally less expensive, once applicable patents expire or patent disputes have been resolved. The Orange Book Transparency Act of 2020 includes a provision for GAO to review Orange Book patent listings for drug-device combination products, including the implications of these listings for generic products. In this report, GAO describes stakeholder views on (1) how Orange Book patent listings affect the entry of generic drug-device combination products into the market, (2) FDA’s role overseeing the Orange Book, and (3) proposals for improving Orange Book patent listings. GAO analyzed FDA documentation, reviewed published literature, and interviewed federal agency officials and 15 stakeholders, including experts, representatives of brand and generic drug companies, and advocacy groups representing patient interests.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (ii, 41 pages))
Illustrations:
Illustrations
NLM Unique ID:
9918627775106676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918627775106676