Frances Kathleen Oldham Kelsey, Ph.D., M.D., physician and pharmacologist, is a leading compliance officer with the Federal Food and Drug Administration. She became nationally known in the 1960s when she withstood great pressure by a leading drug company to quickly approve the drug thalidomide, which was then widely used in Europe primarily to allay morning sickness suffered during pregnancy. Demanding more testing before she would consider approval, Dr. Kelsey saved countless women in the United States from giving birth to terribly deformed children. President Kennedy awarded Kelsey the President's Medal for Distinguished Service for her exceptional judgment in evaluating this new drug. Kelsey was only the second woman to receive this award - the highest award the government gives to civilians.

Dr. Kelsey's brought to the FDA the rigorous standards that typified high quality research in major academic institutions. Her alertness and careful review of the thalidomide application and the subsequent evidence of the danger of that drug resulted in significant strengthening of drug legislation in the United States. Today drug companies must prove not only that drugs are safe, but also that they are effective. Perhaps even more important, drug companies now have to submit enough research to the FDA to prove a drug's safety before it can be tested on humans. No longer can drug manufacturers distribute millions of pills to physicians to distribute to unknowing human "guinea pig" patients.

Dr. Kelsey helped open the door to women in medical and scientific research by proving that women can compete at top academic institutions. She received her Ph.D. in pharmacology in 1938 from the University of Chicago and became an instructor and then assistant professor of pharmacology there. In 1950, after many years of course work, she earned her M.D. degree, also from Chicago. This was at a time when less than ten percent of graduate students and medical students in her field were women. Dr. Kelsey is the author of numerous articles in well recognized scientific journals and the recipient of several prestigious awards and honorary degrees.

Dr. Kelsey is both a woman of courage and one of reason - demanding of herself and others in her profession high standards of science and integrity.

Additional Resources:Edited by: Benjamin F. and Barbara S. Shearer. Notable Women in the Life Sciences: A Biographical Dictionary. Westport, Connecticut; London: Greenwood Press, 1996.

Hoffman, William and Jerry Shields. Doctors on the New Frontier. Macmillan, 1980.

Papers 1913-1997 (bulk 1960-1970), 12,000 items Library of Congress, Manuscript Division. Washington, D.C.