Rx for FDA: An Agenda for the Commissioner
While FDA’s responsibilities have not changed, its capacity to perform its duties has been significantly reduced. After subtracting approximately 4,500 employees[1] from the agency’s 19,000 employee workforce, it cannot possibly sustain its heavy workload.
Outrage is justified. With little more than a wave of a hand, tens of thousands of hours of valuable expertise have been lost. The next challenge will be FDA’s struggle to retain its current appropriated funding levels once rescissions are sent to Congress[2] and House budget cutters dig into other spending vehicles. Last, but hardly least, the $2.6 billion that FDA derives from medical product user fees is under attack by the Secretary of HHS.
A greatly diminished FDA threatens potentially devastating consequences for our nation’s public health and commerce.
Nonetheless, we should all root for FDA’s success. Any other position risks making the situation even worse.
Here are some elements for an FDA action plan that tries to maximize results despite the agency’s diminished capacity.
Continue to incorporate good policy, good medicine, and good science into agency decisions. We know that this is what Dr. Makary intends. However, he did not necessarily sign on for random arbitrary RIF’s and such a substantially diminished staff. Nonetheless, it falls to him to make the best of the situation and to re-create the most effective FDA he can.
First, the Commissioner needs to take careful inventory of the education, skills, and experience of remaining staff, focusing upon rebuilding the multidisciplinary review and inspection teams. Leadership of the agency matters, but it is those teams that get the work done.
Second, inventory in hand, Dr. Makary needs to figure out what FDA can still do, given a workforce that is at least 20 to 25% smaller. Equally important, he will have to figure out what the FDA cannot do (or cannot complete in a specific timeframe)....and address statutory, Congressional, and stakeholder concerns.
Third, the Commissioner must re-start the engine of production. FDA employees are incredibly talented and amazingly committed—but no one could have maintained full productivity from the February 14 lay-offs through the April 1 RIF’s and through the recent tone-deaf visit by the HHS Secretary. It will take time for teams to re-form, and work-arounds figured out. Then it will take additional time for productivity to begin to approach former levels.
We did see some progress with last week’s announcement of FDA’s plans to phase out the animal testing requirement for monoclonal antibodies and other drugs (announcement and Americans for Medical Progress and my comments).
Despite the cries of victory from animal rights groups, the underlying policy is an evolutionary one—roadmaps, pilot projects, and incentives for greater use of animal alternatives where scientifically feasible. It is the result of decades of work by FDA, NIH, and the drug development community.
A few quick solid accomplishments like the animal testing announcement will not make the pain and disappointment go away. But it could get us started on a new narrative that takes the agency from disruption back to production.
The RIF announced by Secretary Kennedy (3,500) and the lay-offs and voluntary separations (reported to be 900-1000 but I have no confirmation). Secretary Kennedy has said that up to 20% of the RIF’ed employees were mistakes who would be rehired, but there is no evidence of follow-through on that. Also, we can reasonably assume there are also unfilled vacancies that occurred between July 1 and December 31, 2024. We do not know if they are included in the 4,500 or are additional to it.
After Easter recess we are told.