[Film leader]
[Frank Reynolds:] There wasan announcement today
by the Food andDrug Administration.
Patina Gregory has the story.
[Patina Gregory:] Today, theFood and Drug Administration
approved what it calls the firstsignificant drug to stop women
from going into labor too soon.
It's called ritodrinehydrochloride,
but it's knowngenerically as ritodrine.
[Tom Jarriel:] A warningtoday to pregnant women
about the possible dangersin coffee, tea, and colas.
[Teletype machine tapping]
The Food and DrugAdministration says
the caffeine in those drinkshas caused birth defects
in laboratory animals andthat until human testing is
more conclusive,expectant mothers
should try to avoidbeverages with caffeine.
[Lea Thompson:] Anotherhealth related
matter-- the FDA todaytook its first step
in putting into action theInfant Formula Act of 1980.
[Paul Berry:] The Food andDrug Administration today--
often in the news and backaround the turn of the century,
unsafe foods and drugswere also in the news.
And that's how FDA came to be.
I'm Paul Berry withthe FDA's story--
a chronicle of scienceand law working together
to protect the Foodand Drug supply
of the American consumer.
[Upbeat music playing]
[FDA 75, 1906-1981]
[Pioneers in Consumer Protection]
[Inspirational orchestration]
[Montage depicting the rangeof FDA activities]
The range of FDA activitiestoday, the scale and complexity
of its responsibilities,contrasts sharply
with FDA's meager beginningat the turn of the century.
Resources were limited,staff few in number,
authority almost nonexistent.
But the Food and DrugAdministration back then
had an invaluable asset--
a truly remarkable man whohelped shape its destiny--
Dr. Harvey Washington Wiley.
[Robert Roe:] I met Dr. Wileyat an AOAC meeting in 1928.
It was quite a thrillto me as a young chemist
to have seen and heard Dr.Wiley, the father of the
Food and Drugs Act of 1906.
Dr. Wiley came to theBureau of Chemistry
from Purdue University,where he had
been professor of chemistry.
He also had served the stateof Indiana as a chemist
during that same period intheir agricultural department.
He was a native ofthe state of Indiana,
I believe, and hadsome farm experience,
and certainly wasinterested in agriculture,
and at the Bureau of Chemistry,engaged in research projects
involving agriculture.
He was a physician.
He had a medical degree.
I do not know whether hehad practiced medicine.
Most of his work had been inchemistry at the university
and in the state,and of course, later,
in the federal government.
[Paul Berry:] In the 20 years thatDr. Wiley and his supporters
fought for federal regulationof foods and drugs,
they exposed conditionsthat, in some respects,
were so horrendous they seemalmost unbelievable today.
Foods were commonly mixedwith harmful fillers
and preservatives.
The lack ofsanitation caused milk
to become a common carrierof communicable diseases.
Medications containingnarcotics were sold freely,
addicting the unwary andcausing numerous deaths.
Quackery flourished.
Worthless medications weresold on the promise they'd
cure virtually every disease.
Dr. Wiley calledfor legislation that
would curb theseharmful practices,
and he urged influentialgroups to join in his campaign.
Strong support came fromfood industry leaders
who were facing both dishonestcompetition and intolerable
variations in state laws.
In 1903, Dr. Wiley capturedthe attention of the nation
when he established avolunteer squad of young men
who agreed to eat foodtreated with suspect chemical
preservatives
[James H. Young:] Wileydecided to set up
what he called a hygienic tablein the basement of the Bureau
of Chemistry building, and toselect a group of young men--
12, he chose-- mostlyfrom the workers
in the Department of Agricultureand his Bureau of Chemistry,
some from outside, and have themeat food only at that table.
Wiley himself, I mightsay, ate most of his meals
with these young men.
Wiley studied theirhealth as they
went through a dietthat had added to it
one of these preservatives.
But newspaper reporterslearned about it.
And it was a WashingtonPost reporter
who coined thephrase "Poison Squad"
and gave rather too muchsensational publicity, as Wiley
thought, to the whole affair.
[Colliers National Weekly]
[Paul Berry:]Crusading journalists
joined in the campaign,helping to arouse
public ire by publishingcartoons, articles,
and editorials.
[The Jungle, Upton Sinclair]
Public opinionreached a fever pitch
when a chapter in UptonSinclair's novel, "The Jungle",
exposed the terrible conditionsin the Chicago stockyards.
[Tense music playing]
[Excerpts from the novel on screen]
The crescendo ofpublic concern prompted
Congress to pass both a meatinspection law and the Food
and Drugs Act.
Both bills were signed into lawby President Theodore Roosevelt
on the last day of June, 1906.
The Food and Drug Actprohibited interstate commerce
in adulterated andmisbranded foods and drugs.
Products that violated the lawcould be seized and destroyed.
Dr. Wiley resigned in 1912.
His successor wasDr. Carl Ellsberg.
Continuing under Ellsbergas chief inspector
and succeeding him was a manwho would influence the agency's
history for four decades--
Walter G. Campbell.
In the early 1930s,Campbell pressed
for revisions in the1906 law to correct
some serious shortcomings.
Campbell showedCongress a series
of posters depicting hazardousproducts that were sold freely
under the existing law.
There were pictures ofa woman whose eyeballs
had been corroded by an anilineeyelash dye, a man who'd
died from a radium waterproduct, quack devices,
risky reducing products,and a stack of death notices
testifying to the failure of ahorse liniment sold to people
as a cure for tuberculosis.
The posters were put togetherwith products and devices
in a dramatic exhibit thatbecame known as the American
Chamber of Horrors.
But it took a nationwidetragedy to change the law.
The crisis emerged in the formof a product that started out
as a boon for many people.
It was called sulfanilamide.
And its infection-fightingproperties
made headlines whensulfanilamide pills
saved the life of FDR's son.
But later, a smallpharmaceutical firm
rushed a liquid form ofthe drug to the market
without testing it for safety.
The liquid form contained thesolvent diethylene glycol,
which is now used in brakefluid and antifreeze.
Disaster struck.
Headlines the countryover broke the news
of a mounting death tollcaused by the solvent in elixir
sulfanilamide.
The tragedies pointed tothe need for a new law
ensuring the safety ofdrugs before marketing.
In 1938, Congress passedthe Federal Food, Drug,
and Cosmetic Act.
President Roosevelt signedthe new law on June 25, 1938.
[William W. Goodrich:] Icame to the agency in 1939,
just about the time the1938 act was taking effect.
What it did was makeimprovements in all areas--
drugs, foods, cosmetics,devices, and so forth.
New drugs were requiredto be proven safe
before they could be marketed.
Avoidable and unnecessarypoisons were banned from food.
And those that were unavoidableor necessary in production
required to be controlledunder safe tolerances.
Food sanitation, foodand drug labeling
were improved extensively.
Economic concerns were addressedthrough standards of identity.
Quality and fill of containerfor foods, cosmetics,
and medical devices werebrought under control
for the first time.
And enforcement wasimproved by authority
for factory inspectionby grant of jurisdiction
for court injunctions byincreased criminal penalties
and extension of theseizure authority.
All of this made formuch better public law.
[Explosions, Naval Station Pearl Harbor]
[Gentle music]
[Paul Berry:] Pearl Harborcatapulted our nation
into World War II.
The FDA staff that wasstretched thin before the war
had to take on amassive drug testing
job created by the new law.
Enforcement of the law went on,and some important victories
were tallied.
An anti-obesityproduct called Marmola,
which consisted of ground-upanimal thyroid glands,
was finally taken off the marketafter 30 years of litigation.
Quack diabetesremedies were removed
from the market, theirpromoters fined and jailed
after vigorous prosecution.
War was also waged by FDA withvarying degrees of success
against quack cancer cures andclinics that delivered nothing
except transient hope.
The discovery andwidespread use of penicillin
on the battlefieldsof World War II
brought more newlegislation requiring
certification of the safetyand efficacy of every batch.
Later, Congress extended thisrequirement to all antibiotics.
New responsibilitieswere legislated to FDA
after the war, as foodtechnology made great advances
with the use of chemicals.
In 1954, FDA was given authorityto enforce tolerance levels
for pesticide residues ofpossible harmful substances
remaining in foodafter harvesting.
In 1958, the agencywas given authority
to requiremanufacturers to prove
the safety of food additives.
In late 1959, SenatorKefauver of Tennessee
began investigatingdrug pricing.
In testimony, it becameclear that other problems
needed consideration as well.
For one thing, therewere inadequate controls
over the distribution anduse of drugs for testing.
Legislation was draftedto correct these flaws,
but it might never havebeen enacted had it not
been for another disaster.
[Frances O. Kelsey:] Theapplication for thalidomide
was submitted to FDAin September 1960.
I was a medical officerassigned to review it,
and it was also reviewed by apharmacologist and a chemist.
We felt the data wasinsufficient to support safety,
and requestedfurther information.
While this wasbeing assembled, we
learned that peripheralneuritis was associated
with the prolonged useof the drug in countries
where it had beenapproved for marketing.
We asked for furtherdata, both regarding
this and possiblesafety in pregnancy.
We asked thisbecause at that time,
there was a developinginterest in awareness
that the fetus andembryo and the newborn
did not always respond todrugs as did the adult.
[Paul Berry:] The answer cameswiftly and conclusively.
Headlines all over the worldreported thousands of cases
in Western Europe of malformedbabies born to women who
had taken the drug thalidomide.
The drug company withdrew itsnew drug application from FDA,
but the thalidomide disaster,though avoided in this country,
stirred strong public reactionand moved Congress to act.
The 1962 amendments to theFood, Drug, and Cosmetic Act
added the requirement thatdrugs had to be effective
before they could beapproved, and also added
other requirements tostrengthen the drug law.
The amendment added a newrealm of responsibility
for the agency.
During the decadeof the '70s, there
was tremendousgrowth in the agency.
It no longer regulated justfoods drugs, cosmetics,
and devices.
In 1971, the agency wasassigned the responsibility
for setting and regulatingsafety standards
for products and equipmentthat emit radiation.
In 1972, theDivision of Biologics
was transferred to FDA from theNational Institutes of Health,
the authority for assuring thesafety, effectiveness, purity,
and proper labeling of biologicssuch as serums and vaccines,
and for overseeingblood bank operations.
With the advances ofhealthcare technology
that employed medical devicessuch as heart pacemakers
and artificial limbs, newmedical device legislation
became necessary.
It was provided in 1976 whenCongress gave FDA the authority
to regulate medical devicesand ensure their safety
and effectiveness.
As a result, life-supportingand implanted devices
must be tested beforethey can be sold.
The responsibilitiesCongress placed on FDA
in the '70s brought FDAstaff to 7,500 employees.
Even with the dramaticgrowth in staff and budget,
enforcement of the increasingstatutory responsibilities
has been an awesome task.
[Music]
In the food area alone, thereare 79,000 establishments
under FDA's jurisdiction.
[Music]
Investigators inspect anaverage of 30,000 establishments
annually.
[Music]
[Food plant conveyor belt]
[Machine noise]
[Investigator:] We have 47investigators in the
Baltimore District.
And there are 6,000establishments
under our jurisdiction.
[Paul Berry:] FDAscientists analyze
approximately 27,000 domestic,and 17,000 foreign products
each year.
[Large laboratory]
[Lab worker:] Here in theBaltimore District Laboratory,
we have 28 scientists whoanalyze product samples,
develop methods ofanalysis, and do research.
[Paul Berry:] The routinework is taxing enough,
but when an emergencydevelops, sheer dedication
gets the job done.
When the nuclear incident atThree Mile Island occurred,
FDA people worked around theclock advising local officials,
collecting and analyzingsamples of food
for possible radiationcontamination,
and providingpharmaceutical antidotes.
When dangeroussubstances, such as PCBs,
get into the food supply, thelights burn all night at FDA.
A PCB spill from oneelectric transformers
sent FDA investigators to1,400 firms in 19 states.
They were there to seethat none of thousands
of contaminatedchickens and turkeys
ever reached the marketplace.
How well FDA does its job istested in that marketplace.
Americans can shop with ahigh degree of confidence,
because our country's foods,drugs, medical devices,
biologics, animaldrugs and feeds,
and radiological productsare the safest in the world.
But conditions change.
New challenges arise.
More than 3/4 of a century ago,when the first Food and Drug
Law was put into effect, themain public health concern
was about the harmful substancesthat were deliberately packed
into foods and medicines.
Today, the concern ismore likely for substances
that end up intoproducts by chance that
have to be detected in partsper billion that remain
in the body for years, waitingto upset cellular mechanisms
and cause cancer.
[Mark Novitch:] Well,we've literally
had a revolution in thiscountry in the past 75 years
in our ability to promotehealthcare through better
nutrition and better care.
And in my judgment,there's every reason
to believe that the futureholds even more dramatic gains
in every field over whichFDA has responsibility.
I think there're goingto be enormous challenges
in everything we do.
The challenge to make sure thatthe benefits of technology,
which is going to beadvancing all the time,
outweighs the risks.
The challenge tonurture innovation
without jeopardizing the publichealth-- and most important,
the challenge to give the peopleof this country confidence
in the products that they useand in the ability of the FDA
to make sure thoseproducts are reliable.
The work has beendifficult in the past.
It's going to be even moredifficult in the years ahead.
But that's what makes ourwork so vital, so challenging,
and to me, very, very exciting.
[Paul Berry:] The Food andDrug Administration--
3/4 of a century old,but still full of youth.
This has been the FDA's story.
[Music]
[Upbeat music]
[Credits]
[Fade to black]
[Color bars]