Time For Independent FDA? COVID-19 Political Pressure Reignites Debate

Time For Independent FDA? COVID-19 Political Pressure Reignites Debate

October 9, 2020, The Rose Sheet

The Rose Sheet covered Gerald Masoudi and Peter Hutt’s FDA panel at the FDLI annual conference, “Time for Independent U.S. FDA? COVID-19 Political Pressure Reignites Debate.” Mr. Masoudi suggests some benefits to the current reporting structure. “If you look at the other functions within HHS with which FDA interacts on a regular basis,” such as the Centers for Disease Control and Prevention, the National Institutes of Health, and the Office of the Surgeon General, “having those function together under common expert leadership on health care issues is very important,” he says.

He adds, “If you had it out from under there, disputes might be more difficult to navigate, coordination may not be as good. So I think there are real benefits to being under the same ownership and leadership of those other organizations.”

Mr. Hutt calls the need for FDA independence a “false issue.” The FDA, he says, has always been under political pressure - usually from Congress - and making the agency a direct report to the Oval Office would not change that reality.

“There has never been a time when political pressure wasn't brought on FDA. Most of the time it's from Congress - not from the President or the White House - and you can't insulate even an independent agency from Congress. When I was chief counsel, I testified before Congress on 80 separate days in four years. That's enormous political pressure. That would be true if FDA was independent or reported to the governor of Alaska. It wouldn't make any difference,” he adds.