Kefauver-Harris Amendment was passed for the drug effectiveness after the Thalidomide tragedy.

1. KEFAUVER-
HARRIS
AMENDMENT
Submitted by:
BANASHREE BARMAN

2. Q.Why this act came in light?
• This amendment was a response to the THALIDOMIDE
TRAGEDY in the late 1950s and early 1960s, where doctors
prescribed Thalidomide to pregnant women to treat their
morning sickness, as Thalidomide has an alternative effect to
treat morning sickness in pregnant women. But original
purpose of marketing thalidomide was due to it’s sedative
effect.
• After the doctors starting prescribing Thalidomide, it was
widely spread in the markets of EUROPE, AUSTRALIA and
JAPAN, due to which 10,000 children approximately were
born with PHOCOLEMIA (condition where limbs are
underdeveloped or missing).
• After this tragedy Thalidomide was banned in markets, but
then also some countries continued the use of Thalidomide

3. Pictures of children born during Thalidomide disaster

4. • In 1961, William McBride, an
Australian obstetrician, reported an
increase of malfunctions happening
to children due to the use of
Thalidomide drug.
• Due to the increase in foetus
malfuntions Thalidomide was
banned in the market and it’s
approval fro the FDA was delayed in
US and therefore it never made to the
US markets.
• In October 1962, Congress passed
the Kefauver-Harris Amendment was
passed which concerned with proof
of drug safety and effectiveness.
• Kefauver- Harris Amendment was
signed by President John F
Kennedy on October 10, 1962.

5. Impact after Kefauver-Harris Amendment in
1962
•Cheap generic drugs could no longer be marketed in market after the
amendment as all drugs needed to prove the safety and efficacy .
•After the Kefauver-Harris Amendment , the FDA’s control over
human experimentation and approval of drugs changed.
•Before this amendment, the drug only needed to prove its safety. But
after this amendment , an FDA New Drug Application (NDA) was
formed where the applicant needed to prove the safety and efficacy of
the drug’s approval.
•The data which is gathered during the animal studies and human
clinical trials of the Investigational New Drug (IND) became a part of
NDA.

6. Goals of NDA
• To check whether the proposed drug is safe
and effective.
• The manufacturing process of the drug
maintain the requirement for drug’s identity,
strength, quality and purity.
• The proposed drug follows the labelling
guidelines.

7. •The documentation in NDA have the complete
drug story, including the clinical
trials,ingredients used in preparation, result
from animals studies, how the drug behave after
administration, manufacturing process,
packaging process.
•Every detail should be provided to NDA for
the approval of drug.
•After the approval from NDA only then the
new drug can be marketed.

9. REFERENCES:
1. James H. Kim, Anthony R. ScialliToxicological Sciences, Volume 122,
Issue 1, July 2011, Pages 1–6, https://doi.org/10.1093/toxsci/kfr088
2. Becker, Gary S. Get the FDA Out of the Way, and Drug Prices Will Drop,
Business Week Magazine, September 16, 2002
3. http://www.slideshare.net/MUHEEM_007/federal-food-drug-cosmetics-
act?from_m_app=android
4. http://www.slideshare.net/dbwalton/history-of-drug-
aproval?from_m_app=android
5. WILLIAM W. GOODRICHFood, Drug, Cosmetic Law JournalVol. 18,
No. 10 (October, 1963), pp. 561-569 (9 pages)Published By: Food and
Drug Law Institute (FDLI)https://www.jstor.org/stable/26655914