OPINION:
President Trump’s first term drew plenty of skepticism among traditional conservatives. He was new to Washington, he had never before held office, and he certainly didn’t talk like William F. Buckley. This concern trickled into the administration itself.
We all see the president as the “thin orange line” between order and chaos, not just against the militant left but also against so many threats abroad. He should have no difficulty staffing appointed positions with true believers. So why is so much nonsense going on at the Food and Drug Administration?
The FDA has devolved into a high school soap opera under Commissioner Marty Makary. His deputies, especially the since-resigned George Tidmarsh and hard-left regulator Vinay Prasad, turned a critical agency into that cafeteria scene in “Mean Girls.”
Caught in the middle are rare-disease patients, the future of biotech and the midterm elections. So, there’s not really a lot of room to worry about the egos of FDA officials as they try to ensure that everyone wears pink on Wednesdays.
On the one hand, we have Mr. Prasad, who proudly describes himself as a far-left “Sanders/Warren progressive” and has, instead of being fired, been elevated to the position of FDA chief medical and scientific officer and director of the Center for Biologics Evaluation and Research. On the other hand, Mr. Makary has been falsely selling “Make America Healthy Again” conservatives on a “plausible mechanism” pathway for ultra-rare diseases.
While Mr. Makary’s rhetoric promises faster, more flexible routes for rare disease therapies, he and Mr. Prasad are using their power to purge senior leadership, sow fear throughout the agency and deny lifesaving therapies at every turn.
Rather than accelerate drug reviews, the FDA slowed them down. Instead of reshoring pharmaceutical manufacturing, one of the president’s promises, the agency’s paralysis is pushing U.S. reliance on China for health care. That is a scary thought.
This FDA’s dysfunction is also undermining one of Mr. Trump’s signature first-term legislative achievements: Right to Try. Families fighting rare or terminal diseases were promised a faster, more compassionate path to experimental treatments. What they got instead was Mr. Prasad’s bottleneck, Mr. Makary’s broken promises and a regulatory culture more interested in infighting and recording podcasts than saving lives.
The deviation from the Trump agenda has become so severe that Health and Human Services Secretary Robert F. Kennedy Jr. and senior White House officials held discussions about whether Mr. Makary should be removed or sidelined.
By early fall, the story around Mr. Makary’s FDA was less about policy and more about picking sides (sort of like whether you were with Regina George or Cady Heron at New Shore High School). Desperate to stabilize the agency, Mr. Makary turned to one of the few universally respected figures in the building: Richard Pazdur, the longtime head of the FDA’s cancer drugs program.
The only problem? Mr. Prasad has spent years relentlessly attacking Mr. Pazdur. So naturally, Mr. Pazdur initially refused the job, a sign of just how far off the rails the FDA has gone under Mr. Makary. Mr. Makary’s team even sent an internal email effectively begging staff to apply for the position before Mr. Pazdur eventually accepted the role as director of the FDA’s Center for Drug Evaluation and Research.
On his first day, instead of announcing bold new initiatives, Mr. Pazdur had to send a morale-boosting email to help calm the turmoil facing FDA employees. When your new chief has to start his tenure by repairing emotional damage, you’re not running the world’s premier lifesaving agency; you’re running a cafeteria clique.
Mr. Trump has made major promises for his second term: faster drug approvals, more cures for rare diseases, lower drug prices and maintaining America’s dominance in the biotech space. Unfortunately, this FDA is doing everything it can to stand in the way of his agenda. Republicans felt this at the polls last month, and if changes aren’t made, they will likely feel it again in the 2026 midterms.
Though he has numerous demands on his attention, Mr. Trump needs to clean house at the FDA. This isn’t all about winning elections or being dominant in the biotech space, though those are very important; this is an actual life-or-death situation for millions of patients across the country. If the president doesn’t step up, the consequences will be catastrophic.
• Jared Whitley has worked in the U.S. Senate, the White House and the defense industry. He has an MBA from Hult International Business School in Dubai.
Correction: A previous version of this column gave an incorrect means of separation from the FDA for Mr. Tidmarsh. The former director of the Center for Drug Evaluation and Research resigned after he was placed on administrative leave amid an internal investigation into his personal conduct.
Please read our comment policy before commenting.