Frances Oldham Kelsey
Born 1914 · Age 111
Canadian-American pharmacologist and physician who, as an FDA reviewer, refused to authorize thalidomide for market in the U.S., helping prevent thousands of birth defects and prompting stronger drug-safety legislation.
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Life & Career Timeline
Born in Cobble Hill, British Columbia
Frances Kathleen Oldham born on Vancouver Island, B.C., second child of an Australian father and Scottish mother.
Graduated St. Margaret's School
Attended St. Margaret's School (1928–1931 reported) and graduated at age 15; early demonstration of academic precocity.
Attended Victoria College (Victoria, BC)
Enrolled at Victoria College (now University of Victoria) for 1930–1931.
Earned B.Sc. in Pharmacology, McGill University
Completed Bachelor of Science at McGill University (B.Sc.).
Earned M.Sc. in Pharmacology, McGill University
Completed Master of Science in pharmacology at McGill University.
Accepted graduate research position with E.M.K. Geiling at Univ. of Chicago
Wrote to E.M.K. Geiling and accepted an assistantship to do graduate work in pharmacology at the University of Chicago.
Assisted FDA-contracted Elixir Sulfanilamide investigation
Worked with Geiling on research showing 107 deaths were caused by diethylene glycol solvent in Elixir Sulfanilamide, an event that highlighted regulatory gaps.
Federal Food, Drug, and Cosmetic Act passed (context)
Congress passed the 1938 Act strengthening drug safety oversight; Kelsey's Elixir Sulfanilamide work is linked to awareness leading to the law.
Completed Ph.D. in Pharmacology, University of Chicago
Awarded Ph.D. in pharmacology; began interest in teratogens and mechanisms of birth defects.
Joined University of Chicago faculty
Became a faculty member at the University of Chicago after earning her Ph.D.
Research on synthetic malaria cures; discovered placental transfer risks
While researching malaria treatments, learned some drugs can cross the placental barrier and affect fetuses.
Married Fremont Ellis Kelsey
Married fellow University of Chicago pharmacologist Fremont Ellis Kelsey; later had two daughters.
Coauthored textbook 'The Essentials of Pharmacology' (initial edition)
Coauthored a pharmacology textbook with Geiling and Fremont Kelsey; later revised through multiple editions.
Earned M.D., University of Chicago
Completed medical degree (M.D.) while on faculty at the University of Chicago.
Editorial associate, JAMA (approx. two years)
Served as an editorial associate for the Journal of the American Medical Association, reviewing therapeutic papers.
Became U.S. citizen (approximate, 1950s)
Became a dual citizen of Canada and the United States in the 1950s to continue practicing medicine in the U.S.
Left University of Chicago; joined University of South Dakota
Moved to Vermillion, South Dakota, to teach pharmacology at the University of South Dakota (1954–1957).
Practiced general medicine in South Dakota
Practiced as a general physician in South Dakota after teaching assignment ended.
Fourth edition of 'The Essentials of Pharmacology' published
Final (fourth) edition of the pharmacology textbook was published in 1960 (work updated over years).
Withheld approval and repeatedly requested additional data
Used the FDA's 60-day withholding rule repeatedly over more than a year to demand rigorous clinical and animal safety data for thalidomide.
Received NDA for thalidomide (Kevadon) from Richardson-Merrell
Assigned to review the New Drug Application for thalidomide, a drug already widely used overseas.
Hired by the U.S. Food and Drug Administration (FDA)
Joined the FDA as one of a handful of full-time medical officers responsible for reviewing new drug applications.
Added concerns after Leslie Florence letter (BMJ) about neurological effects
In December 1960 Leslie Florence published a letter linking thalidomide to neurological symptoms; Kelsey added these concerns to her data requests.
European cluster of birth defects linked to thalidomide
In November 1961 clusters of infants with phocomelia and other malformations were linked to maternal thalidomide ingestion, vindicating her caution.
Named Director of the Investigational Drug Branch (FDA)
Following the thalidomide case Kelsey was named Director of the Investigational Drug Branch and helped shape enforcement of the new amendments.
Experimental thalidomide distribution reached 'tens of thousands' before withdrawal
The company had distributed experimental tablets in the U.S. to many physicians and patients prior to withdrawal (text reports 'tens of thousands').
Confirmed malformed births linked to thalidomide (U.S.-connected data)
By March 1962 there were reports of at least 17 confirmed malformed births linked to thalidomide in contexts connected to U.S. distribution/samples; dozens more suspected.
Richardson-Merrell withdrew U.S. application for thalidomide
After widespread reports of birth defects abroad and mounting evidence, the company withdrew its FDA application.
Washington Post front-page story hailed Kelsey as heroine
Morton Mintz's July 1962 Washington Post article brought Kelsey's actions to national attention.
Received President's Award for Distinguished Federal Civilian Service
Awarded by President John F. Kennedy for preventing a major public-health disaster; second woman to receive this honor.
Kefauver-Harris Drug Amendments passed
Congress passed amendments strengthening FDA oversight (requiring evidence of efficacy, adverse event reporting, informed consent), influenced by the thalidomide case.
University of Chicago Gold Key Award
Received the Gold Key Award from the University of Chicago Medical & Biological Sciences Alumni Association.
Demoted to Chief, Division of Oncology & Radiopharmaceutical Drug Products
Under FDA Commissioner James L. Goddard, Kelsey was reassigned to a lower-profile position and given little work.
Reappointed Director of Scientific Investigations at FDA
After Goddard's departure, Kelsey was reappointed to lead scientific investigations, a role she held for decades.
Involved in regulation of diethylstilbestrol (DES) and DMSO
Played a role in the contentious regulation of other teratogenic or problematic drugs including DES and dimethyl sulfoxide.
Published 'Autobiographical Reflections'
An autobiographical piece compiled from interviews and presentations was published (1993).
Chosen as namesake of Frances Kelsey Secondary School
The town of Mill Bay, British Columbia, named a secondary school in her honor (school opened 1995).
Attended Frances Kelsey Secondary School opening despite injuries
Attended the opening ceremony in 1995 despite suffering broken ribs and a vertebral compression fracture en route.
FDA created special position: Deputy for Scientific and Medical Affairs (Office of Compliance)
A special position at the FDA was created for Kelsey to continue her scientific and medical leadership.
Inducted into the National Women's Hall of Fame
Recognized for historic contributions to public health and drug safety.
Named Virtual Mentor, American Medical Association
Named a Virtual Mentor by the AMA, sharing experience with medical professionals and students.
Retired from the FDA after 45 years
Retired in 2005 after a long federal career spanning 45 years at the FDA.
Received Foremother Award (National Center for Health Research)
Honored as a pioneering woman in health research and policy.
FDA presented first 'Dr. Frances O. Kelsey Award' and named it after her
The FDA created a Drug Safety Excellence Award named for Kelsey; she was the first recipient.
Honorary Doctor of Science, Vancouver Island University
Received an honorary doctorate recognizing her contributions to pharmacology and public health.
Turned 100 years old
Celebrated her 100th birthday on July 24, 2014.
Moved to London, Ontario to live with daughter
Shortly after turning 100, moved from Washington, D.C. to London, Ontario to live with her daughter.
Named to the Order of Canada
Announced as a Member of the Order of Canada in recognition of her service and courage in public health.
Presented with insignia of Member of the Order of Canada
Ontario Lieutenant-Governor visited her home to present the insignia less than 24 hours before her death.
Died in London, Ontario
Passed away on August 7, 2015, one day after receiving the Order of Canada insignia.
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