At that time, drugs could go to market only sixty days after a manufacturer had filed an application with the FDA. If no decision was reached by then, the drug was automatically approved. At the time, drug manufacturers also had “open door” access to the FDA officers assessing their applications, which allowed for coercion and pressure.
By the time the application for thalidomide hit Kelsey’s desk, it was already being prescribed to pregnant women in Europe and Canada as a miracle cure for morning sickness and insomnia. Intended to be marketed as Kevadon in the United States, its selling point was that it was a safe alternative to barbiturates.
But Kelsey, along with two other FDA officers held out their approval, citing a lack of clinical data to support the claims that the drug was safe and effective.
“It was just too positive; this couldn’t be the perfect drug with no risk,” she once said.
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