Frances Oldham Kelsey

Frances Kathleen Oldham Kelsey ( Oldham; July 24, 1914 – August 7, 2015) was a Canadian-American

During Kelsey's second year, Geiling was retained by the FDA to research unusual deaths related to elixir sulfanilamide, a sulfonamide medicine. Kelsey assisted on this research project, which showed that the 107 deaths were caused by the use of diethylene glycol as a solvent. At that time, there was no law available to prosecute those who sold poison as medicine, and Kelsey observed the need to work around incomplete regulation. The next year, the United States Congress passed the Federal Food, Drug, and Cosmetic Act of 1938. Working with Geiling led to her interest in teratogens, drugs that cause birth defects.

In December 1960, Leslie Florence published a letter in the British Medical Journal connecting thalidomide to neurological symptoms. Kelsey saw this letter and added Florence's observed symptoms to her ongoing data requests. The unexpected neurological effects caused her to recall her earlier work on the mechanism of birth defects, so she also requested animal studies to demonstrate that the drug would not be harmful to the fetus. As 1960 turned to 1961, Kelsey's continual requests for more information incurred the ire of her contact at Richardson-Merrell, who insisted on speeding up the approval process and attempted to escalate the application, but Kelsey's superiors at the FDA stood by her. Researchers discovered that the thalidomide crossed the placental barrier and caused serious birth defects. Kelsey was hailed on the front page of The Washington Post as a heroine The drug testing reforms required "stricter limits on the testing and distribution of new drugs"

After Goddard's departure, Kelsey was again appointed Director of Scientific Investigations, and continued in this position for many decades. She was involved in the contentious regulation of diethylstilbestrol, which also caused birth defects, and dimethyl sulfoxide. In 1994, the Frances Kelsey Secondary School in Mill Bay, British Columbia, was named in her honour.

Later life and death

Kelsey retired from the FDA in 2005, at age 90, after 45 years of service. announcing that it would be given to one FDA staff member annually. Kelsey has been memorialized by the National Women's History Museum and the Science History Institute on their respective websites.

Honors and awards

1962 – President's Award for Distinguished Federal Civilian Service 2010 – Recipient of the first Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health given out by the FDA 2012 – Honorary doctor of science degree from Vancouver Island University