“’Regulation is bad. Let’s cut regulations. For every regulation we’re going to cut umpteen regulations.’ That bravado may apply to certain fields, but it can’t and shouldn’t apply when you’re talking about putting a device in someone’s body.”
– Dr. David Kessler
“David is what you hope for in a public servant,” said former Health and Human Services Secretary Donna E. Shalala of former FDA commissioner Dr. David Kessler. “He actually improved public health.”
Dr. David Kessler served as FDA commissioner from 1990 to 1997. He is a pediatrician, lawyer and has an advanced business degree. He was appointed by George H.W. Bush, and re-appointed by Bill Clinton. He became known for his dedication to protecting consumers by focusing on misleading marketing tactics, improving adverse drug reaction reporting systems, food and drug labeling, and tightening regulations on mammography and the use of silicone breast implants.
Following Dr. Kessler’s tenure at the FDA, he became the dean of Yale’s medical school and subsequently Dean of University of California San Francisco, where he discovered a series of financial irregularities, which he courageously brought forth, and was subsequently fired for whistleblowing. An investigation cleared Dr. Kessler of any wrongdoing regarding the irregularities, and he remained a tenured professor of pediatrics and epidemiology.
Dr. Kessler is now an accomplished author, with a variety of books on the body’s relationship to food, such as Your Food Is Fooling You and Hijacked: How Your Brain Is Fooled by Food. He has also written extensively on the tobacco industry’s grip on American health, which was also an important focus of his during his FDA administration.
Dr. Kessler predicted that medical device regulation would become a problem when he originally left the FDA, saying, ”The real challenges of the future will be to come to grips with how the Government should oversee the new technology.” He further discussed this in “The Bleeding Edge,” stating, “The FDA does a credible job with the vast majority of products. The problem we have is that when it comes to medical devices we built a system that doesn’t work…[the 510k process], which was meant as an exception–in that sense, a little loophole–that exception
became the rule.”
“The Bleeding Edge” celebrates Dr. Kessler’s career dedication to truthfully protecting consumers, and commends his continued work helping the public learn about industry’s role in healthcare.
Watch Dr. David Kessler in the Netflix Original documentary, “The Bleeding Edge”.