Former UF leader to participate in national debate on FDA regulation

For some patients, the time it takes for a new, potentially life-saving drug or device to clear regulatory hurdles could spell the difference between life and death. But the Food and Drug Administration’s job is to make sure all drugs and devices are safe before releasing them to the public, no matter how long it takes. So what comes first, safety or speed?

This is a question University of Florida vice president for health affairs emeritus David Challoner, M.D., hopes to answer during a national debate with other leading authorities on Wednesday, May 8. The debate, titled “The FDA’S Caution Is Hazardous To Our Health,” is part of the Intelligence Squared program and will be held in New York City.

Intelligence Squared has held more than 70 Oxford-style debates about topical issues such as the Middle East and the financial crisis, featuring leading experts and thinkers including David Brooks of The New York Times, Howard Dean, the late author Michael Crichton and others. The goal is to bring together experts on both sides of an issue as well as to encourage intelligent discussion and analysis free of emotion and ideological rhetoric.

Each debate features two experts arguing for a position and two arguing against it. Challoner, who led an Institute of Medicine committee on the FDA’s regulatory process regarding medical devices, will be debating against the idea that the FDA’s regulatory caution is hazardous for public health. The other debaters include Scott Gottlieb, M.D., a resident fellow of the American Enterprise Institute, Peter Huber, Ph.D., J.D., a senior fellow of the Manhattan Institute, and Jerry Avorn, M.D., a professor of medicine at the Harvard Medical School.

“My stance will be that the current regulatory authorities for FDA do not give them adequate power to protect the public health and safety of medical devices,” said Challoner, who has held leadership positions in the Association of American Medical Colleges, the American Medical Association and the American Federation for Clinical Research.

Those interested in the debate can watch it live on the Web at intelligencesquaredus.org, view research presented by the debaters on both sides and even vote how they see the issue. The debate begins at 6:45 p.m.

In addition to a live stream, the debate also will be broadcast at a later date on more than 200 NPR stations across the country and on PBS. A podcast of the debate will be available for download.

For more information, visit intelligencesquaredus.org.