The 1937 Elixir Sulfanilamide deaths created the modern FDA pre-approval requirement for new drugs

Evidence

Scandal also continued to play a role in the evolution of food and drug law. In the 1930s, the first antibiotics, the sulfa drugs, came on the market. A drug company, in 1937, had the happy thought of marketing the new wonder drug in liquid form, instead of as pills, which children hate to swallow. There was one slight problem: the solvent was diethylene glycol, which was in fact a deadly poison. Over one hundred people, a third of them small children, died after they swallowed “Elixir Sulfanilamide.” The Food and Drug Administration (FDA) pulled the elixir off the market, of course. But this seemed too little and too late. The furor led Congress to pass new laws, strengthening the FDA, giving it new and more powerful weapons. The FDA had had authority to pull drugs off the market, but now, from 1938 on, no new drug could be marketed at all, unless it had FDA approval—​and this approval depended on elaborate and careful clinical tests. — Lawrence M. Friedman, A History of American Law, 4197

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• SHARE: Good for a friend interested in regulatory history or public health—the specific lethal solvent and the 100-deaths figure that forced pre-market approval.