The Rose Sheet covered Gerald Masoudi’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.”