Dr. Frances Oldham Kelsey: The Unexpected Middle Leader

President John F. Kennedy presenting Dr. Frances Oldham Kelsey with the federal civilian service award in 1962.

It’s easy to fall into the trap of thinking that only charismatic leaders who are at the top of an organization can change the world. For countless ages middle leaders have been and continue to be great change agents. Some have gone head to head with very powerful people and institutions. Some even changed the course of history. Many of them were women.

An example of one of those middle leaders is Dr. Frances Oldham Kelsey. Outside of the field of medicine, Dr. Kelsey’s courage may not be immediately recognizable. But, in the 1960s she single-handedly fought against a large pharmaceutical company, prevented the suffering of millions and helped change those laws that still today impact the care of people.

Dr. Frances Oldham Kelsey served in the middle level of the United States Food and Drug Administration. Dr. Kelsey’s responsibility was to review requests for new drug approval from pharmaceutical corporations. She did not set the vision for the organization. She did not make policy for the organization. She was not considered to be charismatic or even a “leader” in the organization. But one day she initiated great change.

On that day she received a request from the William S. Merrell Company for FDA approval of a morning sickness drug called Thalidomide. The drug was slated to be sold in the United States, with purported millions in profits going to the pharmaceutical company.

As Dr. Kelsey researched the drug and its side effects, it became apparent to her that, despite William S. Merrell’s claim that Thalidomide did not cause congenital disabilities, the drug was, in fact, responsible for many occurrences in Europe and other parts of the world.

With unwavering confidence, and under enormous pressure from both inside and outside of the organization, Dr. Kelsey was able to stall the approval of the drug. In the end, she was correct in her analysis and was not only responsible for sparing millions of children and their families, but she is credited and admired for, “giving rise to modern laws regulating pharmaceuticals.” All of this from the middle of the organization.

Though she served in the FDA in the 1950’s Dr. Kelsey remains a model for all of those who serve in the middle of an organization and an inspiration for those who feel that, because they lead in the middle of an organization, they can’t make a difference.