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July 20, 1963


JAMA. 1963;185(3):209-210. doi:10.1001/jama.1963.03060030067033

The epidemic of congenital abnormalities that followed widespread use of thalidomide in foreign countries has led to anxiety about the use of any drug during the early part of pregnancy. Reaction on the part of the medical profession has been evident in various ways—letters to journal editors reporting instances of congenital abnormalities that were possibly drug-associated, creation of the Commission on Drug Safety of the Pharmaceutical Manufacturers Association, heightened interest in teratology, and public or published warnings by government health officials.

Among the warnings by officials have been statements by Dr. Frances O. Kelsey, chief of the investigational drug branch of the US Food and Drug Administration. Her statements have naturally received wide coverage in the lay press. For example, in an Associated Press story out of Miami Beach, Fla., at the end of April, Dr. Kelsey was reported to have said that many drugs that may cause congenital deformities