FDA-Approved: Protecting the Legacy of Heroes

Written by Lisa Plymate, MD, Co-Chair of the National Physicians Alliance FDA Task Force. Dr. Plymate practices primary care internal medicine and geriatrics in Seattle, Washington.

I was a 10 percenter. I came of age in the late sixties and was one of only ten women in my medical school class, the only woman in my residency cohort of ten physicians, and then at my first job in 1978, the first woman at a 120-physician clinic established in the 1920s in Seattle.
No one else in my family was a doctor. I was motivated by love of biology, sympathy for the poor, and by my medical heroes, Dr. Jonas Salk and Dr. Frances Kelsey. Salk had developed a polio vaccine that saved millions of lives and protected countless more from being paralyzed. Kelsey had led the fight against thalidomide, taking on powerful forces at the FDA in defense of evidence-based drug approvals.
I knew about polio. I knew people crippled by it. I was in the first group of kids – an experimental group in Arizona – to be given the live polio vaccine in sugar cubes at school. It was scary, but nonetheless exciting to feel we were pioneers. And I cannot forget the issue of Life magazine that arrived at our house with all the photos of “thalidomide babies,” children born with flippers for arms and legs.

Jonas Salk at the University of Pittsburgh where he developed the first polio vaccine

Flash forward half a century. I have been practicing internal medicine and geriatrics for more than 30 years, women now constitute over 50% of medical school classes, and I find myself at FDA battlegrounds that echo past fights. I find myself looking to my childhood heroes for inspiration and guidance.
Physicians and researchers have the urge and need to develop novel ways to fight diseases while at the same time doing our best to make sure the drugs and devices we prescribe do not cause harm. There is the urge to be bold as Jonas Salk, balanced by the need to fight like Kelsey and hold our chief regulatory agency, the FDA, accountable as a strong, reliable watchdog. We all want to read the words “FDA-approved” with national pride and clinical confidence.

FDA medical officer Frances Kelsey receives the President’s Distinguished Federal Civilian Service Award from President John F. Kennedy at a White House ceremony in 1962

Historically, federal regulation of food and drugs began in 1906, with the passage of the Pure Food and Drug Act, which primarily focused on foods. The Pure Food and Drug Act was replaced in 1938 by the Food, Drug and Cosmetics Act, interestingly enough, largely because of an earlier drug scandal, when a sulfa elixir was found to contain a solvent that killed more than 100 children (a discovery made in part by none other than Frances Kelsey, then a research assistant at the University of Chicago). It was not until 1962 that the Kefauver-Harris amendments to the Food, Drug and Cosmetics Act passed, largely in response to the thalidomide crisis. These amendments required that drugs be shown to be both safe and effective prior to their market release. The FDA then gained power to oversee prescriptive drug advertising and to establish and monitor satisfactory manufacturing practices in the drug industry. The next major legislation affecting the FDA was the Food and Drug Administration Modernization Act of 1997, which affirmed the FDA’s mission of protecting and promoting the health of the American people, using science for regulatory decision-making.
In recent years, physicians have found themselves in growing tension with the pharmaceutical industry, as our respective interests do not always coincide and in some cases directly conflict. Yes, physicians want real innovation. We need better diagnostic tools; we need truly novel drugs. We want to work with PhRMA, the NIH and the FDA to encourage development, but we must always assure – to the best of our abilities – that drugs are thoroughly tested before being released to the public. We want to offer our patients, especially those with novel disorders, or fatal or disabling diseases, real hope – but not false hope. This is where we must step up to defend the regulatory rigor of the FDA. Drug and device companies may see regulation as a roadblock to discovery and growth; we see regulation as a critical line of defense for public health. Well-done, scientifically-based regulation provides the best pathway to achieving real and lasting innovation. As physicians, we want to know we can trust the label, “FDA-approved.”
My life-long respect for the FDA’s mission and work has led me to join the National Physicians Alliance FDA Task Force, representing doctors across multiple specialties, at all phases of our careers, from across all 50 states, from academia to clinical practices, men and women alike, who aim to keep health at the heart of medicine. We want the FDA to be nimble enough to recognize and embrace significant advances, and to ensure adequate testing of new drugs and devices. We need Jonas Salks and Frances Kelseys.