ABSTRACT
Frances Oldham Kelsey, a bureaucrat, is one hero. In 1962, while working as a staff scientist for the Food and Drug Administration, she prevented the introduction of the drug thalidomide into the United States. Her work led to major legislation, giving the FDA authority to monitor the effectiveness, as well as the safety, of new drugs. Kelsey is a hero of the bureaucratic institution. Frances Oldham Kelsey offers a sharp personal contrast to Peter Rodino: a female scientist-bureaucrat rather than a male lawyer-politician, a reserved Canadian from the Midwestern plains rather than a gregarious Italian American from Newark's dense streets. In August, 1962, President John Kennedy awarded Kelsey the highest honor in the government, the Distinguished Federal Civilian Service medal. A year later, after reorganization at the FDA, she became chief of the Division of New Drugs. The thalidomide controversy illustrates the character of bureaucracy, the newest and largest institution of American government.
