The US Food and Drug Administration is under siege from the Trump Administration, which is forcing through a steady stream of changes in its final days that threaten the remaining independence of the regulatory agency.
Perhaps the most dramatic meddling came on Monday, when FDA officials were blindsided as the agency cycled through three different top lawyers. FDA’s Chief Counsel, Stacy Cline Amin—a Trump appointee—resigned Monday, which FDA Commissioner Stephen Hahn announced in an email. Hahn’s email also included the news that career civil servant Mark Raza, the FDA’s principal deputy chief counsel, would serve as Cline Amin’s replacement on an acting basis. But that decision was abruptly overturned Monday night when the Department of Health and Human services tweeted that James Lawrence, deputy general counsel for the HHS, would serve as the FDA’s new chief counsel until January 20.
“We were all very surprised,” a senior FDA official told Politico. “But it’s consistent with all the fire bombs that keep getting thrown over the fence.”
Last week, HHS said it had finalized a rule that would cause all FDA regulations to expire after 10 years unless they are reviewed. Critics of the rule, called Securing Updated and Necessary Statutory Evaluations Timely or “SUNSET,” noted that the FDA already has mechanisms to sunset outdated regulations, making automatic expiration dates unnecessary. But in a statement announcing the rule, HHS Secretary Alex Azar said that “finalizing our SUNSET rule will deliver for the American people better, smarter, less burdensome regulations in the years to come.”
Next, the HHS moved to permanently waive FDA’s review requirements of medical devices before they hit the market. Seven types of medical gloves have already been permanently exempted, and the HHS has proposed exempting 84 other medical devices, including ventilators, fetal heart monitors, infusion pumps, pediatric facemasks, and medical imaging equipment.
The HHS also moved to force the FDA to publish on its website the time it takes to review new drug applications, claiming that the agency’s current reviews are often too slow.
“A clear abuse of power”
According to reporting by Politico on Tuesday, the FDA is now fighting to keep the HHS from stripping the agency of its oversight of genetically modified organisms—oversight that would instead be transferred to the US Department of Agriculture. The industry-backed plan to transfer oversight is reportedly being pushed by the White House.
FDA Commissioner Hahn reportedly told the HHS that he would refuse to sign the memorandum on the transfer, citing questions about legality and potential health implications for relaxed oversight of certain genetically modified animals.
An FDA source told Politico that the Trump Administration’s move amounted to “a full-frontal assault on public health.”
In a tweet, former FDA Commissioner Scott Gottlieb echoed the concern, writing, “I’ve been disappointed to see HHS infringing on FDA’s public health prerogatives in the closing days of the administration. The way they’re pursuing these unilateral actions will have long-term consequences at a time when FDA’s stature is critical to seeing us through this crisis.”
In yet another strike, Politico reported Thursday that the Trump Administration is working to ram through term limits on top career scientists at the FDA, Centers for Disease Control and Prevention, and other health agencies. The regulation would mandate job reviews every five years, in which scientists would either be renewed or reassigned.
“It’s been a step-by-step escalation in retaliation by HHS against career scientists throughout the pandemic,” a current senior administration official told Politico, blaming HHS Secretary Azar for the flurry of attacks. “It’s a clear abuse of power by Azar.”