LETHAL LIQUID: In 1937, the S.E. Massengill Company of Bristol, Tennessee, began selling bottles of Elixir Sulfanilamide, a liquid version of a popular antibiotic of the day. But more than 100 people died after taking the drug, and investigators from the US Food and Drug Administration (FDA) identified the drug’s solvent, diethylene glycol, as the killer. FDA HISTORY OFFICEThe US Food and Drug Administration’s role in the regulation of novel medicines was born out of tragedy. Seventy-one adults and 34 children died in the fall of 1937 after taking a drug called Elixir Sulfanilamide to treat a variety of ailments, from gonorrhea to sore throat. At that time, the FDA, which had been launched in 1906 as the Bureau of Chemistry, served simply to police claims made about food and drug ingredients. No formal government approval was required to market new drugs.
“The initial 1906 legislation was relatively weak,” says Paul Wax, a medical toxicologist at the University of Texas Southwestern Medical Center. “There had to be some truth to what [drug companies] were selling . . . but in terms of safety, let alone efficacy, that wasn’t part of the equation.”
That all changed in 1938, after the deaths linked to Elixir Sulfanilamide had become a national scandal. Six years earlier, German pathologist and bacteriologist Gerhard Domagk discovered that a chemical called prontosil protected against certain bacterial infections in mice. Further research demonstrated that the compound’s active ingredient, sulfanilimide, could fight streptococcal infections in humans, prompting several pharmaceutical companies—including Merck, Squibb, and Eli Lilly—to begin making sulfanilamide drugs. These medicines were mostly formulated as capsules and ...
