Trump FDA Official Warns Recent Changes at Agency Risk Public Health: Report

AP Photo/Jose Luis Magana, File

Per reporting from The Washington Post on Friday, Dr. Richard Pazdur, a longtime FDA official whom President Donald Trump’s administration recently appointed to be the nation’s top drug regulator, has warned that several fast-tracked initiatives to overhaul drug approvals “pose a risk to public health.”

According to the Post, Pazdur, who was appointed on Nov. 11, has privately raised alarms about the “legality and pace” of FDA Commissioner Marty Makary’s plans to dramatically accelerate drug-related decisions, including proposals to reduce the number of studies required before the agency signs off on changes to drug labels or other regulatory actions.

Makary has argued the shift to a single study would help the FDA “more quickly respond to new evidence,” but Pazdur has countered that multiple studies may still be essential to safeguard patients, explained the Post’s Dan Diamond and Rachel Roubein, who spoke to three sources familiar with the matter.

Pazdur has also questioned a separate Makary-championed drug-review program, embraced by the Trump administration as part of its push for lower drug prices and increased domestic manufacturing. The program allows the FDA to “significantly shorten” review times and expedite approvals for treatments tied to national health priorities, yet Pazdur has reportedly warned colleagues that it’s not transparent enough and “could be illegal.”

Not to mention, Pazdur has also pushed back on Makary’s attempts to sideline certain career scientists from matters that involve “antidepressant medications, puberty blockers, and psychedelics,” arguing that “their involvement is essential to ensure a safe and transparent drug-review process,” as told by the Post’s sources.

The tensions come amid a turbulent stretch for the FDA marked by layoffs, the abrupt resignation of Pazdur’s predecessor, and criticism from industry leaders who this week said the agency’s decisions have become “erratic and unpredictable… creating uncertainty for patients,” according to the Post.

Both men, through HHS statements, defended their work, with Pazdur reaffirming his commitment to public health and Makary calling him “a true regulatory innovator.”