Problems didn’t arise until patients, many of them children like Joan, started taking Elixir Sulfanilamide. Nausea, vomiting, and abdominal pain appeared first, often followed by kidney failure, weakness, and coma for those who had consumed the mixture. For 107 of the drug’s recipients, death was the final outcome. Frances Oldham Kelsey, a steadfast FDA scientist, identified diethylene glycol as the poisonous component of the mixture—something that Watkins, Massengill’s chemist, had not known when designing the concoction. Watkins, who became increasingly overwhelmed by the climbing death toll from his creation, took his own life less than two years after devising the mixture.
Massengill was summoned to court to answer for the disaster his company had unleashed. He was unrepentant: “We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results,” he testified. “I do not feel that there was any responsibility on our part.”
Under the laws of the era, he was right. There was no requirement for demonstrating that new medicines were safe. In fact, the only demand the FDA imposed on new medicines required that they be labeled accurately. Massengill was prosecuted to the maximum extent under this provision (he had misused the term “elixir” on his medicine; an “elixir” must use ethanol as a solvent, not diethylene glycol), and he was fined $26,000—over $400,000 today.
Though legal, the Elixir Sulfanilamide incident catalyzed public interest in drug regulations to prevent such tragedies. Royal S. Copeland, a senator from New York, responded to the outcry by introducing the FFDCA to the Senate on March 5, 1938. After two breakneck trips through both houses, the final FFDCA ended up on President Roosevelt’s desk on a hot Saturday in June, enshrining in law the right and responsibility of the FDA to demand the safety of new foods and drugs with his signature. Elixir Sulfanilamide had claimed no less than 107 innocent lives, but it protected countless more from enduring a similar tragedy.
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The FFDCA protected the public from unsafe medications, but its limitations quickly became apparent. For one part, it provided a short window for the FDA to block unsafe drugs from being sold—only 60 days. For another, it didn’t allow the FDA to ensure the quality of the medications or even to require that they worked as advertised. The Kefauver-Harris Amendments of 1962 helped address these problems. As Margaret Hamburg, the FDA commissioner from 2009 to 2015, explained, “With the passage of the amendments, FDA was no longer a helpless bystander while unproven medicines were streaming into pharmacies and onto patients’ bedside tables.”
Much like the FFDCA of 1938, the Kefauver-Harris Amendments were only passed due to a medical catastrophe—this time the horrific birth defects caused by the sedative thalidomide. While the United States was mostly spared from thalidomide by the work of Frances Oldham Kelsey—the same scientist who determined the poisonous component of Elixir Sulfanilamide—it illustrates how FDA regulations often arise in response to disasters rather than in anticipation of them.