WEBVTT

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[Film leader]

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[Frank Reynolds:] There was
an announcement today

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by the Food and
Drug Administration.

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Patina Gregory has the story.

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[Patina Gregory:] Today, the
Food and Drug Administration

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approved what it calls the first
significant drug to stop women

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from going into labor too soon.

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It's called ritodrine
hydrochloride,

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but it's known
generically as ritodrine.

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[Tom Jarriel:] A warning
today to pregnant women

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about the possible dangers
in coffee, tea, and colas.

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[Teletype machine tapping]

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The Food and Drug
Administration says

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the caffeine in those drinks
has caused birth defects

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in laboratory animals and
that until human testing is

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more conclusive,
expectant mothers

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should try to avoid
beverages with caffeine.

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[Lea Thompson:] Another
health related

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matter-- the FDA today
took its first step

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in putting into action the
Infant Formula Act of 1980.

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[Paul Berry:] The Food and
Drug Administration today--

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often in the news and back
around the turn of the century,

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unsafe foods and drugs
were also in the news.

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And that's how FDA came to be.

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I'm Paul Berry with
the FDA's story--

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a chronicle of science
and law working together

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to protect the Food
and Drug supply

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of the American consumer.

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[Upbeat music playing]

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[FDA 75, 1906-1981]

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[Pioneers in Consumer Protection]

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[Inspirational orchestration]

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[Montage depicting the range
of FDA activities]

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The range of FDA activities
today, the scale and complexity

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of its responsibilities,
contrasts sharply

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with FDA's meager beginning
at the turn of the century.

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Resources were limited,
staff few in number,

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authority almost nonexistent.

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But the Food and Drug
Administration back then

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had an invaluable asset--

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a truly remarkable man who
helped shape its destiny--

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Dr. Harvey Washington Wiley.

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[Robert Roe:] I met Dr. Wiley
at an AOAC meeting in 1928.

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It was quite a thrill
to me as a young chemist

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to have seen and heard Dr.
Wiley, the father of the

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Food and Drugs Act of 1906.

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Dr. Wiley came to the
Bureau of Chemistry

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from Purdue University,
where he had

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been professor of chemistry.

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He also had served the state
of Indiana as a chemist

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during that same period in
their agricultural department.

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He was a native of
the state of Indiana,

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I believe, and had
some farm experience,

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and certainly was
interested in agriculture,

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and at the Bureau of Chemistry,
engaged in research projects

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involving agriculture.

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He was a physician.

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He had a medical degree.

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I do not know whether he
had practiced medicine.

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Most of his work had been in
chemistry at the university

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and in the state,
and of course, later,

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in the federal government.

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[Paul Berry:] In the 20 years that
Dr. Wiley and his supporters

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fought for federal regulation
of foods and drugs,

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they exposed conditions
that, in some respects,

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were so horrendous they seem
almost unbelievable today.

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Foods were commonly mixed
with harmful fillers

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and preservatives.

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The lack of
sanitation caused milk

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to become a common carrier
of communicable diseases.

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Medications containing
narcotics were sold freely,

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addicting the unwary and
causing numerous deaths.

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Quackery flourished.

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Worthless medications were
sold on the promise they'd

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cure virtually every disease.

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Dr. Wiley called
for legislation that

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would curb these
harmful practices,

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and he urged influential
groups to join in his campaign.

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Strong support came from
food industry leaders

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who were facing both dishonest
competition and intolerable

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variations in state laws.

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In 1903, Dr. Wiley captured
the attention of the nation

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when he established a
volunteer squad of young men

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who agreed to eat food
treated with suspect chemical

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preservatives

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[James H. Young:] Wiley
decided to set up

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what he called a hygienic table
in the basement of the Bureau

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of Chemistry building, and to
select a group of young men--

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12, he chose-- mostly
from the workers

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in the Department of Agriculture
and his Bureau of Chemistry,

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some from outside, and have them
eat food only at that table.

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Wiley himself, I might
say, ate most of his meals

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with these young men.

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Wiley studied their
health as they

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went through a diet
that had added to it

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one of these preservatives.

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But newspaper reporters
learned about it.

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And it was a Washington
Post reporter

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who coined the
phrase "Poison Squad"

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and gave rather too much
sensational publicity, as Wiley

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thought, to the whole affair.

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[Colliers National Weekly]

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[Paul Berry:]
Crusading journalists

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joined in the campaign,
helping to arouse

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public ire by publishing
cartoons, articles,

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and editorials.

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[The Jungle, Upton Sinclair]

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Public opinion
reached a fever pitch

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when a chapter in Upton
Sinclair's novel, "The Jungle",

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exposed the terrible conditions
in the Chicago stockyards.

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[Tense music playing]

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[Excerpts from the novel on screen]

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The crescendo of
public concern prompted

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Congress to pass both a meat
inspection law and the Food

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and Drugs Act.

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Both bills were signed into law
by President Theodore Roosevelt

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on the last day of June, 1906.

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The Food and Drug Act
prohibited interstate commerce

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in adulterated and
misbranded foods and drugs.

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Products that violated the law
could be seized and destroyed.

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Dr. Wiley resigned in 1912.

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His successor was
Dr. Carl Ellsberg.

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Continuing under Ellsberg
as chief inspector

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and succeeding him was a man
who would influence the agency's

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history for four decades--

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Walter G. Campbell.

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In the early 1930s,
Campbell pressed

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for revisions in the
1906 law to correct

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some serious shortcomings.

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Campbell showed
Congress a series

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of posters depicting hazardous
products that were sold freely

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under the existing law.

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There were pictures of
a woman whose eyeballs

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had been corroded by an aniline
eyelash dye, a man who'd

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died from a radium water
product, quack devices,

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risky reducing products,
and a stack of death notices

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testifying to the failure of a
horse liniment sold to people

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as a cure for tuberculosis.

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The posters were put together
with products and devices

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in a dramatic exhibit that
became known as the American

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Chamber of Horrors.

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But it took a nationwide
tragedy to change the law.

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The crisis emerged in the form
of a product that started out

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as a boon for many people.

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It was called sulfanilamide.

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And its infection-fighting
properties

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made headlines when
sulfanilamide pills

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saved the life of FDR's son.

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But later, a small
pharmaceutical firm

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rushed a liquid form of
the drug to the market

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without testing it for safety.

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The liquid form contained the
solvent diethylene glycol,

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which is now used in brake
fluid and antifreeze.

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Disaster struck.

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Headlines the country
over broke the news

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of a mounting death toll
caused by the solvent in elixir

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sulfanilamide.

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The tragedies pointed to
the need for a new law

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ensuring the safety of
drugs before marketing.

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In 1938, Congress passed
the Federal Food, Drug,

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and Cosmetic Act.

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President Roosevelt signed
the new law on June 25, 1938.

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[William W. Goodrich:] I
came to the agency in 1939,

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just about the time the
1938 act was taking effect.

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What it did was make
improvements in all areas--

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drugs, foods, cosmetics,
devices, and so forth.

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New drugs were required
to be proven safe

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before they could be marketed.

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Avoidable and unnecessary
poisons were banned from food.

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And those that were unavoidable
or necessary in production

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required to be controlled
under safe tolerances.

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Food sanitation, food
and drug labeling

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were improved extensively.

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Economic concerns were addressed
through standards of identity.

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Quality and fill of container
for foods, cosmetics,

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and medical devices were
brought under control

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for the first time.

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And enforcement was
improved by authority

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for factory inspection
by grant of jurisdiction

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for court injunctions by
increased criminal penalties

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and extension of the
seizure authority.

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All of this made for
much better public law.

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[Explosions, Naval Station Pearl Harbor]

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[Gentle music]

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[Paul Berry:] Pearl Harbor
catapulted our nation

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into World War II.

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The FDA staff that was
stretched thin before the war

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had to take on a
massive drug testing

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job created by the new law.

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Enforcement of the law went on,
and some important victories

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were tallied.

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An anti-obesity
product called Marmola,

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which consisted of ground-up
animal thyroid glands,

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was finally taken off the market
after 30 years of litigation.

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Quack diabetes
remedies were removed

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from the market, their
promoters fined and jailed

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after vigorous prosecution.

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War was also waged by FDA with
varying degrees of success

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against quack cancer cures and
clinics that delivered nothing

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except transient hope.

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The discovery and
widespread use of penicillin

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on the battlefields
of World War II

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brought more new
legislation requiring

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certification of the safety
and efficacy of every batch.

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Later, Congress extended this
requirement to all antibiotics.

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New responsibilities
were legislated to FDA

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after the war, as food
technology made great advances

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with the use of chemicals.

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In 1954, FDA was given authority
to enforce tolerance levels

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for pesticide residues of
possible harmful substances

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remaining in food
after harvesting.

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In 1958, the agency
was given authority

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to require
manufacturers to prove

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the safety of food additives.

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In late 1959, Senator
Kefauver of Tennessee

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began investigating
drug pricing.

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In testimony, it became
clear that other problems

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needed consideration as well.

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For one thing, there
were inadequate controls

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over the distribution and
use of drugs for testing.

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Legislation was drafted
to correct these flaws,

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but it might never have
been enacted had it not

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been for another disaster.

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[Frances O. Kelsey:] The
application for thalidomide

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was submitted to FDA
in September 1960.

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I was a medical officer
assigned to review it,

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and it was also reviewed by a
pharmacologist and a chemist.

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We felt the data was
insufficient to support safety,

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and requested
further information.

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While this was
being assembled, we

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learned that peripheral
neuritis was associated

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with the prolonged use
of the drug in countries

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where it had been
approved for marketing.

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We asked for further
data, both regarding

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this and possible
safety in pregnancy.

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We asked this
because at that time,

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there was a developing
interest in awareness

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that the fetus and
embryo and the newborn

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did not always respond to
drugs as did the adult.

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[Paul Berry:] The answer came
swiftly and conclusively.

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Headlines all over the world
reported thousands of cases

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in Western Europe of malformed
babies born to women who

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had taken the drug thalidomide.

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The drug company withdrew its
new drug application from FDA,

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but the thalidomide disaster,
though avoided in this country,

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stirred strong public reaction
and moved Congress to act.

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The 1962 amendments to the
Food, Drug, and Cosmetic Act

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added the requirement that
drugs had to be effective

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before they could be
approved, and also added

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other requirements to
strengthen the drug law.

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The amendment added a new
realm of responsibility

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for the agency.

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During the decade
of the '70s, there

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was tremendous
growth in the agency.

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It no longer regulated just
foods drugs, cosmetics,

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and devices.

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In 1971, the agency was
assigned the responsibility

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for setting and regulating
safety standards

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for products and equipment
that emit radiation.

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In 1972, the
Division of Biologics

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was transferred to FDA from the
National Institutes of Health,

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the authority for assuring the
safety, effectiveness, purity,

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and proper labeling of biologics
such as serums and vaccines,

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and for overseeing
blood bank operations.

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With the advances of
healthcare technology

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that employed medical devices
such as heart pacemakers

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and artificial limbs, new
medical device legislation

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became necessary.

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It was provided in 1976 when
Congress gave FDA the authority

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to regulate medical devices
and ensure their safety

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and effectiveness.

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As a result, life-supporting
and implanted devices

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must be tested before
they can be sold.

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The responsibilities
Congress placed on FDA

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in the '70s brought FDA
staff to 7,500 employees.

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Even with the dramatic
growth in staff and budget,

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enforcement of the increasing
statutory responsibilities

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has been an awesome task.

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[Music]

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In the food area alone, there
are 79,000 establishments

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under FDA's jurisdiction.

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[Music]

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Investigators inspect an
average of 30,000 establishments

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annually.

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[Music]

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[Food plant conveyor belt]

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[Machine noise]

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[Investigator:] We have 47
investigators in the

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Baltimore District.

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And there are 6,000
establishments

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under our jurisdiction.

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[Paul Berry:] FDA
scientists analyze

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approximately 27,000 domestic,
and 17,000 foreign products

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each year.

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[Large laboratory]

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[Lab worker:] Here in the
Baltimore District Laboratory,

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we have 28 scientists who
analyze product samples,

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develop methods of
analysis, and do research.

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[Paul Berry:] The routine
work is taxing enough,

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but when an emergency
develops, sheer dedication

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gets the job done.

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When the nuclear incident at
Three Mile Island occurred,

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FDA people worked around the
clock advising local officials,

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collecting and analyzing
samples of food

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for possible radiation
contamination,

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and providing
pharmaceutical antidotes.

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When dangerous
substances, such as PCBs,

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get into the food supply, the
lights burn all night at FDA.

16:10.266 --> 16:12.799
A PCB spill from one
electric transformers

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sent FDA investigators to
1,400 firms in 19 states.

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They were there to see
that none of thousands

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of contaminated
chickens and turkeys

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ever reached the marketplace.

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How well FDA does its job is
tested in that marketplace.

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Americans can shop with a
high degree of confidence,

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because our country's foods,
drugs, medical devices,

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biologics, animal
drugs and feeds,

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and radiological products
are the safest in the world.

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But conditions change.

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New challenges arise.

16:45.566 --> 16:49.232
More than 3/4 of a century ago,
when the first Food and Drug

16:49.233 --> 16:52.233
Law was put into effect, the
main public health concern

16:52.233 --> 16:55.066
was about the harmful substances
that were deliberately packed

16:55.066 --> 16:56.699
into foods and medicines.

16:56.700 --> 16:59.533
Today, the concern is
more likely for substances

16:59.533 --> 17:01.999
that end up into
products by chance that

17:02.000 --> 17:04.933
have to be detected in parts
per billion that remain

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in the body for years, waiting
to upset cellular mechanisms

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and cause cancer.

17:10.433 --> 17:11.899
[Mark Novitch:] Well,
we've literally

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had a revolution in this
country in the past 75 years

17:16.433 --> 17:20.199
in our ability to promote
healthcare through better

17:20.200 --> 17:24.300
nutrition and better care.

17:24.300 --> 17:27.400
And in my judgment,
there's every reason

17:27.400 --> 17:32.366
to believe that the future
holds even more dramatic gains

17:32.366 --> 17:38.099
in every field over which
FDA has responsibility.

17:38.100 --> 17:40.233
I think there're going
to be enormous challenges

17:40.233 --> 17:42.099
in everything we do.

17:42.100 --> 17:46.900
The challenge to make sure that
the benefits of technology,

17:46.900 --> 17:51.266
which is going to be
advancing all the time,

17:51.266 --> 17:52.732
outweighs the risks.

17:52.733 --> 17:56.533
The challenge to
nurture innovation

17:56.533 --> 18:00.799
without jeopardizing the public
health-- and most important,

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the challenge to give the people
of this country confidence

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in the products that they use
and in the ability of the FDA

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to make sure those
products are reliable.

18:14.133 --> 18:15.933
The work has been
difficult in the past.

18:15.933 --> 18:20.099
It's going to be even more
difficult in the years ahead.

18:20.100 --> 18:23.966
But that's what makes our
work so vital, so challenging,

18:23.966 --> 18:27.599
and to me, very, very exciting.

18:27.600 --> 18:29.500
[Paul Berry:] The Food and
Drug Administration--

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3/4 of a century old,
but still full of youth.

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This has been the FDA's story.

18:35.866 --> 18:36.766
[Music]

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[Upbeat music]

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[Credits]

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[Fade to black]

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