Enlarge /. Stephen Hahn, Commissioner for the US Food and Drug Administration.
The U.S. Food and Drug Administration is besieged by the Trump Administration, which has been forcing a steady stream of changes over the past few days that jeopardize the regulatory agency's remaining independence.
Perhaps the most dramatic meddling came on Monday when FDA officials were blind as the agency ran through three different top lawyers. Stacy Cline Amin, FDA Chief Counsel, a Trump-appointed person, resigned Monday, FDA Commissioner Stephen Hahn announced in an email. Hahn's email also contained the message that career official Mark Raza, the FDA's deputy chief executive officer, would act as Cline Amin's replacement. However, that decision was abruptly overturned on Monday night when the Department of Health and Human Services tweeted that James Lawrence, HHS deputy general counsel, would serve as the FDA's new chief counsel through Jan. 20.
"We were all very surprised," a senior FDA official told Politico. "But it agrees with all the fire bombs that are thrown over the fence over and over again."
Last week, HHS said it finalized a rule that would cause all FDA regulations to expire after 10 years unless reviewed. Critics of the rule, known as Securing Updated and Necessary Regulatory Assessments in a Timely manner, or "SUNSET," noted that the FDA already has mechanisms in place to override outdated regulations so that automatic expiration dates are not required. In a statement announcing the rule, HHS Secretary Alex Azar said, "The completion of our SUNSET rule will bring better, smarter and less burdensome rules to the American people in the years to come."
Next, HHS waived FDA medical device review requirements before they hit the market. Seven types of medical gloves have already been permanently exempted, and the HHS has proposed the exemption of 84 other medical devices, including ventilators, fetal heart monitors, infusion pumps, pediatric face masks, and medical imaging machines.
The HHS also forced the FDA to post the time it takes to review new drug applications on its website, claiming that the agency's current reviews are often too slow.
"A clear abuse of power"
According to a report by Politico on Tuesday, the FDA is now fighting to prevent the HHS from removing the authority's oversight of genetically modified organisms – oversight that would instead be delegated to the U.S. Department of Agriculture. The industry-backed plan to delegate oversight is reportedly being driven by the White House.
FDA Commissioner Hahn reportedly told HHS that he would refuse to sign the memorandum on the transfer and raised questions about the legality and potential health effects for loose surveillance of certain genetically modified animals.
An FDA source told Politico that the Trump administration's move was "a frontal attack on public health."
In a tweet, former FDA Commissioner Scott Gottlieb reiterated the concern, writing, “I was disappointed that HHS has violated the FDA's public health prerogatives in the last few days of administration. The way they pursue these unilateral actions will have long-term ramifications if the FDA's stature is critical to guiding us through this crisis. "
In another strike, Politico reported Thursday that the Trump administration is working to exceed deadlines for top-career scientists at the FDA, the Centers for Disease Control and Prevention, and other health officials. The regulation would require a review of jobs every five years, with scientists either renewed or reassigned.
"It has been a gradual escalation in retaliation by HHS against professional scientists throughout the pandemic," a current senior administrative official told Politico, blaming HHS Secretary Azar for the spate of attacks. "It is a clear abuse of power by Azar."