US drug regulatory authority under pressure

US Food and Drug Administration (FDA) Commissioner Marty Makary is under renewed pressure by Trump officials amid ongoing turmoil at the agency, including several prominent departures that have raised doubts about Makary's leadership, two people familiar with the discussions said.

The upcoming departure of Dr. Richard Pazdur — a veteran researcher who helped shape the FDA's modern approach to cancer treatment — has drawn the most concern, according to sources quoted by the CNN on Saturday.

Pazdur is set to retire this month, only weeks after accepting a position leading the FDA's largest division, which oversees prescription drugs, over-the-counter medicines, and common pharmacy products.

Pazdur's departure comes amid broader conflicts with FDA leadership over who should oversee the agency's key divisions and how to balance accelerated drug approvals with quality standards, according to three people familiar with internal discussions.

The sources said the breaking point for Pazdur came when Makary pushed him to replace longtime career drug regulators with Makary's own preferred hires.

Makary has until now been a close ally of Health and Human Services Secretary Robert F. Kennedy Jr., but Kennedy — who met Pazdur for an hour on Wednesday — has grown frustrated with the ongoing public turmoil, the sources said.

Pazdur's exit has sparked widespread concern in the administration and the pharmaceutical industry that it could disrupt the drug review system and weaken trust in the FDA, long considered the global gold standard for regulating drugs and vaccines.

Makary was already set to meet White House officials on Friday, but one person familiar with the situation said the session took on added urgency following Pazdur's resignation announcement.

Spokesmen for the White House and the Department of Health and Human Services (HHS) denied on Friday that Makary's position was at risk, saying senior officials remain fully confident in his leadership and the agency's direction.

"The White House maintains complete confidence in Marty Makary and the entire team at HHS and FDA," White House spokesman Kush Desai said, praising "the near-weekly flow of groundbreaking FDA announcements."

The White House "maintains complete confidence in Marty Makary and the entire team at HHS and FDA," said the spokesman Kush Desai, hailing "the near-weekly flow of groundbreaking FDA announcements."