“It’s been a step-by-step escalation in retaliation by HHS against career scientists throughout the pandemic,” said a current senior administration official, blaming HHS Secretary Alex Azar for the last-minute moves. “It’s a clear abuse of power by Azar.”
The rule would have immediate implications for half of the Food and Drug Administration’s six center directors — including those who oversee medicine and vaccine reviews plus tobacco policy — and a host of senior researchers at the CDC, the Indian Health Services and Centers for Medicare and Medicaid, said four people familiar with the rule.
A senior administration official told POLITICO the move is not intended to target particular individuals or agencies.
“This is intended to be a good governance action,” the senior administration official said. “Congress did this through the 21st Century Cures Act with NIH. I think NIH was largely supportive because it would increase diversity or opportunity for certain positions at the agency.”
The sweeping 2016 law mandates five-year reviews for center directors at the National Institutes of Health, including the chief of the National Institute for Allergy and Infectious Disease, Anthony Fauci.
But many career officials have since questioned the move, arguing it made scientists leading a range of departments — from cancer research to infectious-disease studies — subject to the will of the White House. The new policy would dramatically expand the number of scientists affected across HHS’s subsidiary agencies.
One former HHS official said the Trump administration knows the midnight regulation, like many of its other last-minute regulations, will likely be tossed out in court. But the official speculated the action is intended as a roadmap for future administrations looking to more easily reassign career staffers.
“[HHS General Counsel] Bob Charrow has been around since the Reagan administration, he knows what he’s doing at the end of an administration,” the former HHS official said. “It is very intentional, he’s giving the Trump supporters a bunch of ideas even if Biden takes it away.”
News of the impending regulation comes less than a week after FDA Commissioner Stephen Hahn told reporters that it was “very timely” to consider whether the food and drug agency should be carved out of HHS to assure its independence. In little over a year in office, Hahn battled with the White House and Azar to uphold standards for reviewing coronavirus vaccines and over emergency authorizations of several drugs.
“It is so important for the FDA that we remain an independent regulatory body, that our decisions are rooted only in data and in science and in medicine,” Hahn said last Friday.
The idea has support from across the aisle: In January 2019, seven former FDA Commissioners called for the agency to be moved out of HHS and re-established as an independent federal agency.
HHS developed the new term-limit policy and sought to push it through without notifying the agencies that would be affected by it, said a person familiar with the process. FDA only found out about HHS’s plans when staff at the Federal Register flagged problems with the draft and sent it to FDA for comment, the person said.
“There should have been a fuller discussion of this,” said one senior HHS official, noting that the end of the Trump administration is just days away. “Having an argument over term limits, on its merits, is a reasonable thing.” the official said. “On the other hand, what about institutional memory, what about stability for industry?”
The last-minute rule could arrive as Janet Woodcock, a nearly four-decade veteran of the FDA who has led its drug review department for almost half of that time, is being floated as acting commissioner for the Biden transition. There are reports that president-elect Joe Biden could name Woodcock his permanent commissioner pick; the longtime FDA director declined to comment.
Adam Cancryn contributed to this report.