I sometimes encounter a cynicism about the health care regulatory process completely disproportionate to actual knowledge of the health care regulatory process. I can be plenty cynical about some aspects of the health care regulatory process myself but I can't pretend that health care regulation has been for nought. Indeed, I sometimes think about starting a list of great moments in health care regulation.
Today, I offer an entry on the parallel list of great heroes of health care regulation, remembering the work of Frances Kelsey, the FDA officer who blocked the full introduction of thalidomide in the American market. She died only recently at the age of 101.
One of the things most striking about her willingness to stand up for safety was her relative youth and newness to the FDA. Her legacy: the 1962 enactment of the Kefauver-Harris Drug Amendments that mandated “substantial evidence” of a drug’s effectiveness as developed by “experts qualified by scientific training,” in addition to evidence of a drug’s safety, and provided for greater oversight of drug investigations.
As thalidomide's legacy fades, with an estimated 5,000 thalidomide survivors remaining worldwide, my students most often have never heard of thalidomide and certainly never met a survivor. But we discuss thalidomide in Health Law. Its role in the history of pharmaceutical regulation should not be forgotten, nor should Frances Kelsey.