Frances Oldham Kelsey (1914-2015) was a pharmacologist and government official recognized for her role in preventing thalidomide, a drug shown to cause severe birth deformities, from entering the United States market.

Kelsey was born July 24, 1914 in Cobble Hill, Vancouver Island, British Columbia, Canada to Frank Trevor Oldham, a retired British officer, and Kristin Oldham (née Stuart) and had two brothers. Frances studied in Victoria, British Columbia before moving to Montreal to study at McGill University where she received her BS degree in 1934 and her MS in 1935. She moved to the United States to attend the University of Chicago where she earned a PhD in Pharmacology studying under Dr. E.M.K. Geiling, a leader in pharmacology. In 1937, Geiling was brought in to help with investigations of the Elixir Sulfanilamide Tragedy. Kelsey helped Geiling’s investigation as a lab assistant - her first experience working with drug investigations. After obtaining her degree in 1938, she joined the faculty as an instructor and later as an assistant professor of pharmacology.

In 1943, she met and married Fremont Ellis Kelsey, a colleague in the pharmacology department. In 1948, she co-authored a classic textbook, Essentials of Pharmacology, with her husband and Dr. Geiling. She began taking courses at the University of Chicago’s medical school and was awarded her MD in 1950. From 1950 to 1952 she worked as an editorial associate on the Journal of the American Medical Association. In 1952, the Kelseys moved to Vermillion, South Dakota where Fremont Kelsey became chairman of the department of physiology and pharmacology until 1960. Frances worked as an associate professor from 1954-1957 after which she began a private practice. In 1956, she became a naturalized citizen.

In 1960, Fremont Kelsey accepted a position with the National Institute of Health in Washington, D.C. Frances Kelsey accepted a position as a medical officer with the Food and Drug Administration (FDA) of Department of Health, Education, and Welfare. Her first assignment at the FDA was reviewing an application from the William S. Merrell Company to clear thalidomide, a sleeping pill, to be marketed under the trade name Kevadon. Although already marketed and sold in Europe since 1957, Kelsey noticed that drug behaved differently in animals. With the backing of the FDA, she withheld approval and requested the Merrell provide more documentation. From 1960 to 1961, Kelsey investigated the drug and resisted pressure from the company to push through its approval. In November 1961, German scientist Dr. Widukind Lenz reported that the epidemic in Europe of phocomelia, the malformation of limbs in newborn babies, was linked to thalidomide. Kelsey was hailed for preventing the tragedy in the United States and shed light on the need for stricter regulations on new drugs entering the market.

On August 7, 1962, Kelsey was presented the Award for Distinguished Federal Civilian Service by President John F. Kennedy, the highest award a federal servant can receive. Kelsey testified in August in a Senate subcommittee on the regulation of experimental drugs. A more effective drug bill was signed in October 1962, which led to the creation of the Investigational Drug Branch which evaluated and regulated new drugs. Kelsey was appointed head of this new department which would be restructured in 1967 as the Division of Scientific Investigations. She would work at the FDA until her retirement in 2005. Kelsey received several awards in recognition of her work. In 2000 she was inducted into the National Women’s Hall of Fame. In 2010, she became the first recipient of an FDA award in her name, the Dr. Frances O. Kelsey Drug Safety Excellence Award, which has since been given annually. She was appointed to the Order of Canada in 2015, a month before her death. She died on August 7, 2015 in London, Ontario at the age of 101.

References

"Kelsey, Frances O." Current Biography (Bio Ref Bank)(April 1, 1965): Biography Reference Bank (H.W. Wilson), EBSCOhost (accessed October 19, 2016).

Kelsey, Frances. "Autobiographical Reflections." Unpublished memoir. Folder 1, Box 1, Linda Lear collection of Frances Kelsey materials, 1962-2013. Linda Lear Center for Special Collections and Archives, Connecticut College.

Lear, Linda.“In memoriam: Frances Oldham Kelsey.” The Life and Legacy of Rachel Carson, http://www.rachelcarson.org/mFrancesKelsey.aspx (accessed October 31, 2016).