Dr. Frances O. Kelsey receives the President's Award for Distinguished Federal Civilian Service from President John F. Kennedy, 1962 (National Library of Medicine, Images from the History of Medicine, A018057)
Dr. Kelsey went on to write the rules that govern most clinical drug trials today. She retired from the FDA in 2005 at age 90.
“I had the feeling throughout the day, that they were at no time being wholly frank with me and that this attitude has obtained in all our conferences, etc., regarding this drug.”
-Dr. Frances O. Kelsey remembering her meetings with William S. Merrell Drug Company
In the early sixties, pictures of children with horrific birth defects, particularly underdeveloped legs and arms, began to appear in the media. These birth defects were soon linked to the drug thalidomide, which was widely prescribed throughout the world to prevent morning sickness in pregnant women. The United States was largely spared this tragedy thanks to the work of one woman, Dr. Frances Oldham Kelsey, a new employee of the Food and Drug Administration (F.D.A).
After the success of thalidomide in Europe, the drug company William S. Merrell petitioned the Food and Drug Administration in 1960 to be allowed to market the drug in the United States. Dr Kelsey was assigned to review the application. Dr. Kelsey, who has a Ph.D. in pharmacology as well as a medical degree, had been on the job for only a month, but was troubled by the lack of evidence that the drug was safe for human use. Dr. Kelsey pressed the company for additional research. Her insistence on sufficient documentation kept thalidomide off the U.S. market for over a year, sufficient time for doctors to uncover the link between thalidomide and birth defects. In 1962, the drug was taken off the market, but not before 10,000 children had been impacted. It is estimated that 40 percent of babies with thalidomide-induced birth defects died before their first birthday. The thalidomide tragedy, with its shocking pictures, was widely covered in the media.
Regulating Drug Testing in the United States
Although thalidomide was never licensed in the United States, it was distributed as samples to American doctors to try with their patients. It was common practice at that time for drug companies to pass on experimental drugs to doctors, who were then paid to collect data on their patients’ results. Patients did not normally know or consent to their part in this loosely controlled research. The thalidomide tragedy moved Congress to pass legislation to protect patients from medical experimentation without their consent and to require testing of new drugs before their distribution. Dr. Kelsey went on to write the federal rules that continue to govern every clinical drug trial in the United States and was the first official to oversee them. Dr. Kelsey retired from the F.D.A. in 2005 at age 90.
For her part in preventing the distribution of thalidomide in the United States, Dr. Kelsey was awarded the distinguished Federal Civilian Service Medal by President Kennedy on August 7, 1962. In September 2010, the F.D.A awarded Dr. Kelsey, now 96, the first Kelsey Award in honor of her service. The Kelsey Award will be awarded annually to an F.D.A. staff member