We attended AgencyIQ's webinar this week regarding "How the Trump Administration is Affecting the FDA." Alexander Gaffney, VP Regulatory Policy and Intelligence, and Laura DiAngelo, Senior Director of Research, covered the latest moves by the Trump administration, how they will affect FDA and, in turn, their effect on industry.
They started with staffing, a story that has gotten a lot of attention in the news. Staff buyouts, a hiring freeze, planned reductions in force, reorganization plans, return-to-office mandates, and office closures reduce the number of staff available for FDA tasks and disrupt day-to-day work for those who remain, making attrition more likely. Unlike other agencies, FDA adopted remote work even before the pandemic, so staff required to "return" to the office may never have worked at an office previously, meaning that even at full capacity, FDA offices were not sized to hold the current number of employees. The speakers noted that FDA turns over approximately 8% of its staff per year, requiring the agency to hire up to 2000 staff per year to keep up with attrition. The new attrition plan, however, requires that FDA hire no more than one employee for each four that depart. FDA positions can be specialized, so if four departed reviewers are replaced with one, three areas of expertise could be lost.
Reduction in staffing levels will naturally impact performance. The speakers have not yet noted delays in reaching PDUFA dates, but they noted that FDA's PDUFA dashboard is already out of date, and in individual cases this lagging indicator would not be evident for several months down the road. (When we tried to access this web page, the site displayed an old-school frowny face icon, but we were able to download data - however, as the AgencyIQ team noted, it was currently only through FY 2023.) MDUFA publishes quarterly performance reports, with the next one expected in May 2025. They noted that SEC reports from sponsors might be early indicators of delays.
Regulations are expected to be fewer, slower, and less transparent. In late January, the President issued an executive order decreeing that each agency must retire 10 rules, regulations, or guidances for each new one it implements. Staffing challenges could delay new regulations: The speakers noted that the Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) final rule has already been delayed twice. Staffing challenges will also make it more difficult for FDA to publish supporting guidances that help constituents implement regulations. In late February 2025, HHS overturned the Richardson Waiver, which required HHS to include comment periods before implementing regulations, which not only will reduce transparency but could result in loss of quality, as the public will not have the opportunity to raise concerns.
As FDA slows down in general, there is a fear that the US will become "out of sync" with the rest of the world in terms of harmonization. In the last month ICH published two final guidelines (E6 R3 and an eCTD Q&A v4.0), but we have no information on when they will be adopted. FDA typically provides input into ICH drafts, but if staffers can't travel to attend working parties, we may lose this ability to contribute to international standards.
Ideology could be a driver in terms of pressure on the agency to enact administration priorities, such as restrictions on birth control, abortion, and vaccines. Congress's legislative agenda includes plans for multiple bills that could affect public health and FDA. Speakers noted that due to Trump's noxious executive order on sex and gender, FDA is making small editorial changes to ICH documents. Most of us are already aware of the odious "disclaimer" on FDA's draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. The tension between the classically Republican "MAGA" movement and the more libertarian "MAHA" (RFK's Make America Healthy Again movement) could erupt in conflicts over the proper amount of regulation and FDA's relationship with industry.
The speakers discussed the impact the new FDA commissioner could have on the environment. They noted that most new FDA commissioners come in with a mission, but Marty Makary hasn't stated any priorities. They noted that Makary will undoubtedly face pressure regarding mifepristone, foreign trade, and RFK's "health" priorities. The speakers ran through a laundry list of issues that did NOT come up during Makary's confirmation hearing, including his stance on compounded drugs, vaccines, deregulation, and clinical trial diversity initiatives.
Speakers noted that their industry colleagues are concerned about political ramifications on FDA inspections. Since FDA investigators represent themselves abroad as United States government agents, their
Thanks to AgencyIQ for an informative session!
