The document summarizes the history of the FDA approval process, beginning with Harvey Wiley in the late 19th century advocating for pure food laws. Key events included the 1906 Food and Drug Act which banned adulterated food/drugs, the 1938 Food, Drug and Cosmetic Act which mandated quality standards, and the 1962 Kefauver-Harris Amendment requiring drug efficacy and safety proof in response to Thalidomide defects. In 2016, the FDA approved 22 out of 151 new drug applications, around 15%. The FDA approval process exists to protect consumers from adulterated or misbranded products.

1. The history of Food and
Drug Administration (FDA)
approval process
Expert: Michael Basham

2. Harvey W. Wiley
 Known as the “Father of the Pure and Drug Administration”
 1880 was a Chief Chemist at the Department of Agriculture
 1880 – 1890 , pure food bills introduced into the Congress
based on Wiley’s work but weren’t approved
 In 1902, Wiley organized a volunteer group of men called,
Poison Squad, tested adulterated foods on themselves

3. Important events that built the FDA
Food and Drug
act of 1906
Food, Drug, and
Cosmetic Act of
1938
Kefauver-Harris
Amendment in
1962

4. Food and Drug Act of 1906
 Consumer protection laws that
led to the creation of the FDA
 Ban foreign and interstate
traffic in adulterated or
mislabel food and drug
products
“…Because your methods, facilities, or
controls for manufacturing, processing,
packing, or holding do not conform to CGMP,
your drugs are adulterated within the
meaning of section 501(a)(2)(B) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act), 21
U.S.C. 351(a)(2)(B).”

5. Food and Cosmetic Act of 1938
• This act mandated quality, and
identity standards for foods
• prohibition of false claims for
drugs
• Covers Cosmetic and Medical
Devices
• The right to audit
• Granted FDA the right to control
the advertisement of products

6. Kefauver-Harris Amendment in 1962
• “Drug Efficacy Amendment”
• Required that before approval drug manufactures show:
• Proof of effectiveness
• Safety of their drugs
• Disclose side effects and symptoms on advertisements
• Set cGMP standards
• Was made in response to thalidomide

7. Thalidomide
Chemie Grunenthal, marketed their drug in
1957 as Contergan - Germany
drug can “cure” anxiety, insomnia and
tension
pregnant women bought the drug to stop
morning sickness
Over 10,000 cases of children born with
defects –Europe
FDA- Dr. Frances Kelsey
Rejected Thalidomide
100 Cases in the US

8. 1 1
4
2
4
2 2
0
1
2
0
3
JANUARY FEBRUARY MARCH APRIL MAY JUNE JULY AUGUST SEPTEMBER OCTOBER NOVEMBER DECEMBER
Approval of A New Drug Application (ANADA)-2016

9. FDA Approved 15% of New Drugs Application in 2016
Applications, 151
Approved , 22
2016 DRUG APPROVAL
15%
85%

10. FDA is their to protect the rights of consumers
• You need to go through the FDA if you want to sell your product
• FDA importance is that it holds biopharmaceuticals and companies
responsible of their products
• To protect the interest of patients and consumers from adulteration
and misbranding