health
Marty Makary resigns as FDA commissioner following industry and White House backlash
Makary's tenure was marked by internal dysfunction at the FDA, leadership turmoil and mounting backlash from drugmakers and physicians on regulatory decisions.
TL;DR
- Dr. Marty Makary resigned as FDA commissioner on Tuesday.
- President Trump announced Kyle Diamantas as the acting commissioner.
- Makary's tenure was marked by internal dysfunction, leadership turmoil, and backlash from drugmakers, physicians, and patient groups.
- Issues included high-profile rejections of rare disease treatments and slow movement on policy initiatives like flavored vapes.
- The Susan B. Anthony Pro-Life America organization called for Makary's ouster over the FDA's handling of the abortion pill mifepristone.
- Staff morale reportedly plummeted due to layoffs and departures of career scientists, with some citing Makary's leadership.
- Controversial appointees like Vinay Prasad, who oversaw vaccines and biotech treatments, also faced criticism and left the agency.
- The pharmaceutical industry expressed wariness about a shakeup due to ongoing negotiations for the reauthorization of the Prescription Drug User Act Fee.
- Sen. Ron Johnson announced an investigation into the FDA's rejection of rare disease treatments.