Elixir Sulfanilamide - 1937
Aside from the Pure Food and Drug Act of 1906 and the Harrison Act of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control insuring the safety of new drugs until Congress enacted the 1938 Food, Drug, and Cosmetic Act in response to a drug poisoning crisis.
In 1937, S. E. Massengill Co., a pharmaceutical manufacturer, created a preparation of sulfanilamide using diethylene glycol (DEG) as a solvent, and called the preparation "Elixir Sulfanilamide". DEG is poisonous to humans, but Harold Watkins, the company's chief pharmacist and chemist, was not aware of this (although it was known at the time). The company chemist merely added raspberry flavoring to the sulfa drug which he had dissolved in DEG and the company marketed the product. Although animal testing should have been routine in most drug company operations, Massengill performed none and there were no regulations requiring premarket safety testing of new drugs.
The company started selling and distributing the medication in September 1937. By October 11, the American Medical Association received a report of several deaths caused by the medication. The Food and Drug Administration was notified, and an extensive search was conducted to recover the distributed medicine. [Frances Oldham Kelsey assisted on a research project, which verified that the excipient DEG was responsible for the fatal adverse effects. At least 100 deaths were blamed on the medication.
The owner of the company, when pressed to admit some measure of culpability, famously answered, "We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part." Massengill's chief chemist, Harold Watkins, committed suicide while awaiting trial.2
Congress responded to public outrage by passing the 1938 Food, Drug, and Cosmetic Act which required that companies perform safety tests on their proposed new drugs and submit the data to the FDA before being allowed to market their product. The Massengill Company paid a minimum fine under provisions of the 1906 Pure Food and Drugs Act which prohibited labeling the preparation an "elixir" if it had no alcohol in it.