An act passed by Massachusetts, which led the way in state-sponsored food and drug laws. The
Vaccine Act of 1813, though short-lived, was the first federal law dealing with consumer protection
and therapeutic substances.
Consisting of only a few men, the bureau did little more than request customs inspections of imported
foods and to a lesser extent drugs. Harvey Washington Wiley, head of the Division of Chemistry of the
U.S. Department of Agriculture, predecessor of the FDA, is pictured here around 1899 with his
technical staff behind him.
Harvey Wiley, third from right, is photographed with his staff from the Division of Chemistry, U.S.
Department of Agriculture, not long after he arrived in Washington in 1883.
Sulfanilamide Tragedy-1937
One of the most consequential mass poisonings of the 20th century
Well established Pharma Industry (Massengill ) was desperate to find suitable solvent to
dissolve Sulfanilamide, and to develop a new liquid dosage form for throat infections
(streptococcus)
A chemist was given the responsibility to find the solvent
• He found Diethylene glycol (used as antifreeze in vehicles)
• Safety and efficacy tests were done for the drug
• No animal toxicity test was done for solvent
Result
• 107 people died after ingesting Elixir Sulfanilamide
• Most dead were children
Reason?
• Diethylene glycol - deadly poison for kidneys
Federal control
• Premarketing toxicity testing was not required
• The FDA could prosecute Massengill merely for misbranding :
the product Elixir Sulfanilamide did not contain alcohol and therefore did not fit the definition
of an elixir
Nothing could be done about the Elixir deaths because Massengill had not made fraudulent
claims for the product
• At the time of the Elixir episode, the common law did provide remedies for harm
from misbranded or adulterated drugs
• Massengill was successfully sued for its gross negligence
• The chemist responsible for creating Elixir Sulfanilamide committed suicide
• The “Elixir Sulfanilamide tragedy” prompted the passage of the
Thalidomide Disaster-1962
• In 1957, a West German pharmaceutical manufacturer introduced a new sedative,
thalidomide, which alleviated the symptoms of morning sickness in women during
the first trimester of pregnancy.
• In 1962, by which time the drug had been sold in 46 countries, it became clear that
thalidomide damaged the fetus, causing stillbirth or, most prevalently, phocomelia
(Greek for "seal limb").
• Thousands of newborn babies were found to have truncated limbs that resemble
flippers.
• Kefauver-Harris Amendments were soon implemented
• The amendments authorized the FDA to require drug companies to conduct and
submit tests determining safety and efficacy.
• the FDA now had to preclear all human trials, drug advertising, and labeling.
• The FDA also increased its regulatory power over manufacturing.
• FDA, which increased its staff from one thousand members in 1951 to nearly 6500
two decades later
• Proving efficacy was very difficult than proving safety
• Drug development declined significantly after 1962, and the wait for new life-
saving drugs increased to more than a decade by the end of the 1970s
• People cited thalidomide in claiming that drug approval delay is a blessing
• Animal Drug Amendments of 1968