Kelsey's first assignment, in September 1960, involved an application from the William S. Merrell Company of Cincinnati, which had purchased the American rights to a drug called thalidomide that had been marketed under various trade names in Europe since 1957. As permitted by drug laws of the time, the company had already distributed samples to several American doctors on an experimental basis.

Cautious Response.

Despite the drug's extensive use in Europe, Kelsey was suspicious after studying test reports supplied by Merrell and noticing that it behaved differently in animals from other similar drugs. She withheld approval of the drug and asked Merrell to give the FDA more information about the effects of the drug.

Suspicions and Recriminations.

Kelsey still did not know exactly what she was looking for, but she was concerned that the drug might affect fetuses. Though she carefully sought more evidence as to...