Federal attempted to market Kevadon, a brand of

Federal Food, Drug and Cosmetic
(FD&C) Act of 1938 did not accurately regulate drugs.  This Act allowed drug companies to sell a drug
“if the FDA did not act within 60 days to prevent its marketing.” In addition,
in 1938, the FDA did not have the autonomy to enforce good manufacturing or
clinical practices. During this time period, there were a lot of unsafe and
ineffective drugs in the market. Senator Kefauver’s investigation into the
pharmaceutical industry revealed over-promotion of drugs and false advertising
of the side effects and efficacy of drugs in the market. One of the biggest
drug scandals at that time involved thalidomide.

Thalidomide, if taken during the first
trimester of pregnancy, would kill the fetus, cause the fetus to be blind,
deaf, have digestive problems, have missing limbs, shortened limbs,
missing/extra fingers or toes or webbed fingers or toes. Due to these side
effects, thalidomide was not approved for use in the United States. FDA medical
officer Frances Kelsey stopped the approval of the drug application due to
inadequate safety data. Despite the disapproval, the William S. Merrill company
attempted to market Kevadon, a brand of thalidomide in the United States, and distributed
the thalidomide to various physicians. “There were 17 births of deformed
infants” because of thalidomide use in the United States. The FDA launched a
campaign to recover the drugs to prevent further complications. Thalidomide that
had been approved and used in other countries resulted in thousands of children
being born with birth defects.

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The Kefauver-Harris Amendment of
1962, also known as the Drug Efficacy Amendment Act, was an amendment to the
FD Act of 1938. This amendment was signed by President John F. Kennedy on
October 10,1962 with the help of Tennessee Senator Estes Kefauver and Arkansas
Representative Oren Harris. The Kefauver-Harris Amendment changed the way new
drugs were approved and regulated. Before the Thalidomide tragedy, U.S.

pharmaceutical companies were able to get their drugs approved by simply showing
the FDA their products were safe. However, now the companies would be required to
file a New Drug Application illustrating safety and effectiveness of the new
products. The FDA has 180 days to approve the application before a drug can be
marketed in the United States. Regular inspection of production facilities is
also required. Sponsors need to establish the efficacy of the drug and meet the
FDA’s safety requirements, otherwise the drug will not be approved. Pre-1962 drugs
that were already on the market were tested for safety and effectiveness as
well under this amendment. Drug are required to go through multiple phases of clinical
trials, called Phase I through Phase IV. Any adverse drug reaction also needed
to be reported to the FDA. One additional effect of this change to the FD&C
Act of 1938 was that it prevented cheap generic versions of drugs from being
marketed as “breakthrough” drugs under new trade names.

Stricter controls of clinical
trials were enforced by the FDA as well. The current good clinical practice
elements, that is, rules for clinical trials on human subjects, are in response
to the thalidomide incident in particular. These rules require, defined responsibilities
for the Principal Investigator in a study; Institutional Review Board oversight;
monitoring of the clinical studies by the sponsor/manufacturer; informed consent
for participating subjects prior to dosing, approved study protocol; an
explanation for any deviation, documentation and record retention; and a test
drug or medical device control sample.  



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