By: Stephen M. Ostroff, M.D.
Last week our nation lost a true pioneer in public health and consumer protection.
Frances Oldham Kelsey, Ph.D., M.D., who joined FDA in 1960 as a medical officer, was known worldwide as a leader in drug safety and the protection of patients. She established that reputation in one of first FDA assignments: reviewing the marketing application for a drug called thalidomide, which was already available in dozens of countries around the world.
Despite constant pressure from the company, Dr. Kelsey refused to approve thalidomide because of inadequate evidence about its safety. As a result of Dr. Kelsey’s expertise, diligence, and integrity, the drug was never approved in the United States and Americans were largely spared the tragic birth defects and deaths experienced by patients in those countries where thalidomide was available.
This “near miss” spurred Congress and the White House to revive pending proposals to revitalize the oversight and regulation of pharmaceutical products. In the wake of the thalidomide episode, the Kefauver-Harris Drug Amendments became law in 1962. That law mandates “substantial evidence” of a drug’s effectiveness (in addition to evidence of safety that was previously required) and today continues to provide this road map for how unapproved pharmaceutical products are tested in humans.
It is fair to state that these amendments, as implemented by FDA, ushered in the modern era of science-based proof that the medicines we use are both safe and effective, a level of evidence that created a standard still in effect today.
Dr. Kelsey’s original work on the thalidomide application stands today as a legendary example of how FDA carries out its public health mission: judicious exercise of authority and oversight to protect consumers and patients.
Dr. Kelsey joined FDA during a different era and was a trailblazer in many ways, including the role of women in science. And yet, although this is a new era, our mission endures: to promote innovation while protecting the health and welfare of Americans. And FDA continues to be defined by the same rigor, dedication, and integrity that informed Dr. Kelsey’s work.
Our nation owes a great debt of gratitude to Dr. Frances Oldham Kelsey for her decades of service to public health.
Stephen M. Ostroff, M.D., is Acting Commissioner of the Food and Drug Administration
More information about Dr. Kelsey’s life and career is available in her “Autobiographical Reflections,” which FDA released on the occasion of her 100th birthday in 2014.