The majority of the tragic birth defects that occurred were in other countries because Thalidomide had not been approved for use in the United States.

[1] In addition, the Amendment required drug advertising to disclose accurate information about side effects and efficacy of treatments.

Before the Thalidomide scandal in Europe, and Canada,[5] U.S. drug companies only had to show their new products were safe.

[citation needed] Louis Lasagna, then a prominent clinical pharmacologist at the Johns Hopkins School of Medicine, advised Congress about the proper conduct of clinical research during the 1962 hearings leading up to passage of the Amendment.

The law also exempted from the "Delaney clause" (a 1958 amendment to the Food, Drugs, and Cosmetic Act of 1938) certain animal drugs and animal feed additives shown to induce cancer, but which left no detectable levels of residue in the human food supply.