The Thalidomide Tragedy

Thalidomide Tragedy (1957 to 1961)

During post-war times in Germany, thaliomide was prescribed to people that
were hooked on tranquilizers and sleeping pills.
It was the only non-barbituate sedative known at the time
It was popular in other areas of Europe and so people thought the drug was
safe.
Around this time, an obstetrician found that the drug alleviated morning
sickness.
However, this drug produced some very serious, adverse reactions
The OB started to associate the drug with serious birth defects in the babies
that were born.
The drug caused the babies to have phocomelia, resulting in shortened,
absent, or flipper-like limbs.
Reports were sent out about the drug and it was banned in most countries
who thought it was safe.
So we passed the Kefaurer-Harris Amendments
Congress passed a law saying that before a drug goes on the market, it must
be tested for safety and provide substantial evidence of effectiveness on the
drugs intended use.
A requirement for the informed consent of participants in the study
Formalized good manufacturing practices, required that adverse events to be
reported and transferred the regulations of prescription drug advertising
from the Federal Trade Commision to the FDA.

Sources:
http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/Promotin
gSafeandEffectiveDrugsfor100Years/
https://helix.northwestern.edu/article/thalidomide-tragedy-lessons-drugsafety-and-regulation