Dr. Marty Makary: The FDA needs new leadership

COVID has given us a clear-eyed look at a broken Food and Drug Administration that’s mired in politics and red tape. 

Diversity in the leadership of any organization is important because different life experiences can help solve problems and challenge a status quo. But our top FDA and NIH leadership lack minority and age diversity.

This starts at the top. Our public health leaders have become too be accepting of the bureaucratic processes that would outrage a fresh eye. For example, last week the antiviral pill Molnupiravir was found to cut COVID hospitalizations in half and, remarkably, no one who got the drug died. 

The irony is that Molnupiravir was developed a year ago. Do the math on the number of lives that could have been saved if health officials would have moved fast, allowing rolling trials with an evaluation of each infection and adverse event in real-time. Instead, we have a process that resembles a 7-part college application for each of the phase 1, 2, and 3 clinical trials.