Over 100 Years
of the FDA:
brought to you by
Life Sciences
A Star Group Division
A (Very) Brief History & Timeline
Upton Sinclair writes The Jungle, shedding light
on the issue of unsanitary meat processing plants,
and creating demand among the public for
regulations and protections for public health.
1906
The Pure Food and Drug Act was signed by
Theodore Roosevelt the same day as the Federal
Meat Inspection Act; it ensured the cleanliness
of food and forbade the adulteration of drugs.
1906
The Bureau of Chemistry in the U.S. Department
of Agriculture, responsible for enforcing the
Pure Food and Drug and Federal Meat
Inspection Acts, is renamed the Food and
Drug Administration.
1930
1937
An improperly prepared sulfanilamide, an antibiotic,
caused a mass poisoning, resulting in over 100 deaths.
1938
The Food, Drug, and Cosmetic Act authorizes the
FDA to oversee the safety of food, drugs, and cosmetics.
Drugs must be tested in animals for safety and cannot
make false therapeutic claims. The concept of
prescription-only medications is introduced.
1951
The Durham-Humphrey Amendment codifies the
“prescription-only” designation into law.
Thalidomide was marketed in Europe as a treatment
for nausea and insomnia. Though never approved in
the U.S., it was used by many pregnant women
worldwide, causing birth defects. Scientists did not
know at the time that drugs taken during pregnancy
could affect the fetus.
1959
After the thalidomide tragedy, the Kefauver Harris Amendment
to the FD&C act required that drugs show proof of efficacy, and
required that advertising disclose side effect information.
1962
Drug Price Competition and Patent Term Restoration Act
(“Hatch-Waxman Act”) extends the patent exclusivity
for new drugs, essentially creating the modern generic
drug industry.
1984
1989
Billy Joel releases “We Didn’t Start The Fire”
and sang about the children of thalidomide.
See “1959”.
2014
The FDA releases guidance for Pharma
brands hoping to deploy social media
tactics after years of industry anticipation.
Comments Enabled
FDA Guidance on Social Media &
User-Generated Content
Read our summary —>
(click the cover)
What Does Each Depatment
of the FDA Regulate?
Center for Drug Evaluation and Research
Drugs! “Drugs” are defined as: recognized in an official
pharmacopoeia of formulary; intended for use in the
diagnosis, cure, mitigation, treatment, or prevention of
disease; or (other than food) intended to affect the structure
or any function of the body of a man or other animals.
Center for Biologics Evaluation and Research
Biologics! “Biologics” are defined as produced by
living cells or tissues rather than by chemical process.
Examples include vaccines, allergenics, and gene therapy.
Center for Devices and Radiological Health
Medical Devices! These are devices used in medical
procedures, which includes everything from tongue depressors
to machines for radiation therapy in cancer treatment.
Center for Food Safety and Applied Nutrition
Food, Dietary Supplements, and Cosmetics! “Food” is ... an article of
food or drink for man or other animals, chewing gum… and food additives.
This center is responsible for the “Nutrition Facts” panels on packaged foods.
“Cosmetics” are articles (other than soap!) used on or in the human body
for cleansing, beautifying, or altering appearance.“Dietary Supplements”
may make structure or function claims but not claims to cure or prevent
disease (unless a claim is approved as a food product).
Center for Veterinary Medicine
Pet Health! This center regulates distribution of food,
food additives, and drugs that will be given to animals;
all are defined for animals as they are for humans.
Center for Tobacco Products
Smokes! The CTP was recently established, in 2009, to
set performance standards for tobacco products, review
premarket applications for new and modified risk of tobacco
products, and enforce advertising and promotion restrictions.
Office of Regulatory Affairs
Enforcement! ORA enforces the laws governing the
other regulatory departments within the FDA, meaning
they ensure that all products which may have potentially
harmful side effects for the consumer are accurately
represented to the public.
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Life Sciences
A Star Group Division
©2014 Star Group Communications, Inc
Tim R. Garde
Managing Partner, Star Group and Star Life Sciences
[email protected]
215.875.4313 (l) 215.815.0075 (m)
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