A Fussy, Stubborn and Unreasonable Woman: The Contributions of Frances Kelsey to Safety and Science

Frances Oldham Kelsey. This name may not ring a bell, but it should. She died on August 7 at the age of 101. But how does Dr. Kelsey affect you?

Dr. Kelsey began working at the FDA in August, 1960, one of 7 full time medical officers hired to review human drug applications. Early in her career, she refused to approve a particular drug—for 19 months! She was called a fussy, stubborn, unreasonable bureaucrat. But she persisted.

The drug that Dr. Kelsey refused to approve? Thalidomide.

At least 10,000 cases of birth deformities were reported in worldwide (17 in the US). Because of this tragedy, new regulations in the US (the Kefauver-Harris amendments) strengthened the FDA’s authority over drug testing, and required pharmaceutical companies to conduct phased clinical trials.

According to FDA historians, Dr. Kelsey was also instrumental in establishing the institutional review board. For decades, Dr. Kelsey played a critical role at the FDA in enforcing federal regulations for drug development—protocols that were credited with forcing more rigorous standards around the world.

Dr. Kelsey’s work affects you every day. When you work with the IRB, when you check a regulation, think of her. Our job is to get the work done, but also to protect our participants. We must always be diligent. We need to make sure we are noting adverse events, counting pills accurately, filling out ALL the paperwork. Encourage your co-workers. Keep up with your continuing education to be sure you are up to date. Be the best researcher you can be! You may be the next person to be called fussy and stubborn, when you say, “We have to follow the regulations.”

— Annette Oeser, Research Assistant III, Division of Clinical Pharmacology at Vanderbilt University