Short Takes and Updates—February 20, 2025
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1. FDA At Risk on Four Fronts
All the federal public health programs are under siege. While my focus is on FDA, I want readers to know that NIH and CDC face similar (but not identical) threats.
Reduction In Force (RIF). The new Administration sent lay-off notices to an unknown number of FDA staff over the holiday weekend. The common element is that they were on probationary status and thus have a lower level of job protection. I described and commented on this in my column earlier this week: If Being Mission Critical Is Not Important Enough, What Is?
The situation is still unclear as of midday on February 20. Over the last 24 hours, I have been responding to reporters with the following statement:
From watching OMB and FDA interpret these types of orders and directives in 2017, I learned there is a lack of clarity when they are first announced. Whether and how much FDA would be affected requires reading the fine print—in the overall declaration and then how it is to be applied to the massive responsibilities, different personnel systems, multiple funding sources, and wide range of skills needed at FDA.
In this case, we do not know the numerator (laid off by center/office) or the denominator (total laid off at FDA), so it is impossible to talk about either general or specific impacts. We need to let the dust settle.
For those of us who are watching, it is frustrating not to know. For FDA employees--those who are living it—it is probably closer to excruciating.
FY 2025 Appropriations/Possible Shutdown. FY 25 has been funded by Continuing Resolutions since October 1 of last year. The current CR expires on March 14 and so far, there is no deal on total spending or specific bills. According to Politico, “Republican appropriators sent a new offer to their Democratic counterparts over the weekend.”
FDA is at risk in two ways. If they reach an agreement, there is potential for FDA funding to be cut. If they do not reach an agreement, then there could be an additional CR or a shutdown.
Budget Reconciliation. Compared to the other two threats, this one is going to take longer and unwind a bit more slowly but could lead to substantially greater downward pressures on domestic discretionary programs. I did a deep dive on this last week: FDA and Budget-Reconciliation 2025: A Primer and supplemented it here. The process continues in both the House and Senate.
Impoundment of Appropriated Funds (new and a wildcard). President Trump and OMB Director Russ Voight have asserted the President’s authority to impound Congressionally-appropriated funds….notwithstanding Constitutional provisions that have always been interpreted to the contrary. It is possible that FDA funds could be impounded, and the agency drawn into this battle. (h/t to Alec Gaffney at Agency IQ. You can sign up for their daily newsletter, FDA Today, at https://www.agencyiq.com/subscribe-fda-today/).
2. FDA and the Upcoming Attempt to Gut Medicaid: Are There Any Overlapping Issues?
The status of Medicaid may seem to be in doubt[1], rather than pre-determined. However, under the pending House Budget Resolution, House Energy and Commerce committee will be expected to deliver $880 billion in savings over the next decade. There is no way to achieve that result without massive reductions in the Medicaid program. All options to do so are painful[2].
As reconciliation efforts advance in the House and Senate, the status of Medicaid is going to be grabbing headlines. On the one hand, the President’s agenda and tax cuts cannot be paid for without the Medicaid cuts. On the other hand, the traditional Republican position on the value of Medicaid is going to clash with the reality that Medicaid (including program expansions of the last dozen years) are popular in many red states.
My question to FDA Matters’s readers: do FDA and FDA stakeholders have a stake in the Medicaid battle? If so, what are the issues?
3. What I Am Listening To
Wayne Pines and Shelly Garg have launched FDA Watch (https://fdawatch.libsyn.com/), which offers podcasts about FDA. I recommend signing up.
This week’s guest is Janet Woodcock, discussing FDA’s future and the evolving regulatory landscape. You can also catch my appearance on January 20, along with Marc Scheineson of Alston & Bird, discussing the “The New-Look FDA in 2025.”
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Forward this e-mail to colleagues and friends and urge them to subscribe at www.fdamatters.com.
Politico has reported this morning that: “Hours after pledging that the safety net program [Medicaid] “is not going to be touched,” Trump surprised some of his own staff Wednesday when he endorsed a House budget that would gut Medicaid.”