The HHS RIF: Frequently-Asked Questions About FDA
Lots of media inquiries yesterday about the consequences of the HHS RIF announcement (Announcement, Fact Sheet). Here is what I told reporters:
“The FDA’s portion of the reduction in force is 3,500 and that would be in addition to those who took buyouts (voluntary separation) earlier. Reviewers and inspectors are exempt. Logically, the policy, compliance, data collection, and regulatory staff are most at risk, as well as those whose jobs might be centralized at HHS.
However, this is a reaction to the size of the RIF and the unknown size and distribution of the buyouts. We will not know for certain until we see the HHS plan.”
Note that the RIF’s are not a 100% certainty. The union representing FDA employees, the National Treasury Employees Union (NTEU), has said it will oppose the RIF by all means possible (statement here). RAPS Focus reported late yesterday that a lawsuit had been filed.
In the “day-after” mode with lots of unknowns, here is my FAQ with some educated guesses:
Q: Relative to the FDA workforce, how big is the RIF?
A: The RIF is about 18% of FDA’s total staff of about 19,000. However, we know that less than 19,000 employees are at risk because:
an unknown number of buyouts have already diminished the total number of employees;
an unknown number of FDA positions are vacant and not likely to be filled…and may or may not count as a “reduction in force” depending on whether the reductions are counted as FTE slots or actual people[1];
review staff and inspectors are excluded from the RIF, although it is unclear whether the intention is “reviewers” or “review teams,” which would make a severalfold difference in how many FDA employees are exempt from the RIF.
certain FDA offices will have their functions centralized at HHS; and FDA is unlikely to be credited with a RIF for any employees who are transferred within HHS and do not contribute to the department RIF target.
Q: Will the RIF exemption be “reviewer” or “reviewer teams,” “inspectors” or “inspector teams?”
A: It will be in the Administration’s interest to define the exemption narrowly and keep the pool of RIF-eligible individuals as broad as possible. However, in practical terms, it would make no sense to protect a medical reviewer from a RIF, but not the individuals who the reviewer relies upon, such as a biostatistician. Likewise, an inspector in the field is of limited value without individuals to analyze, process, and act upon the inspector’s findings.
Commissioner Makary understands this distinction, but it is unclear how much autonomy FDA will have to select which offices, job categories, and individuals will be RIF’ed. The ability to retain effective teams after lay-offs was explored in my column “What is Happening to Federal Workers at FDA: An Analogy May Help,” which can be found here.
Q: Will so-called “user fee employees” be protected from the RIF?
A: No. Whether your salary is being paid from user fees or BA funds makes no difference. You can still be laid off. My article explaining this--“Special Edition: FDA RIF’s and User Fees Explained”—can be found here. FWIW: of my twenty or so FDA Matters columns, this is by far the most widely read.
Q: What do we know or can surmise about the distribution of the 3500 employees who will be RIF’ed?
A: There is enough uncertainty about who is exempt that there is logic, but not evidence, for certain conclusions. My first reaction, provided to media yesterday, was that “the policy, compliance, data collection, and regulatory staff are most at risk, as well as those whose jobs might be centralized at HHS.”
The Commissioner’s staff offices would appear to be at particularly high-risk, as well as their counterparts in each of the Centers. However, I do not believe that will provide nearly enough people for a 3,500 person RIF, plus some of those individuals may be transferred within HHS or retained for other reasons.
I am concerned about the potential for misunderstanding if anyone other than the Commissioner’s office makes the decisions. For example, there are a large number of vital cross-cutting initiatives that are not self-explanatory, such as IT systems development, AI, regulatory science, the Agency for Toxicological Research, cosmetics regulation, and antibiotic resistance.
Q: Should food programs be particularly concerned about the RIF given the Administration’s food program priorities under the MAHA initiative?
A: I have a column that will appear soon in Food Safety News (www.foodsafetynews.com) that addresses this question. It will be reprinted on the FDA Matters website and distributed a couple of days after it appears in FSN.
Q: What is the overriding flaw in the answers I have provided?
A: They all assume that there is an actual plan, and that the RIF will proceed in an orderly fashion with consistent and logical rules as to which offices, job categories, and individuals will bear the brunt of the RIF.
Given the handling of the initial DOGE-led firings that started on February 14, the Administration has given us no reason to believe there is a coherent and realistic plan in place for achieving the target of 3,500 RIF’s at FDA. If there is no plan, then analysis (mine or anyone else’s) may be of limited predictive value.
BONUS: FDA took all budget documents off their website in late January, making it nearly impossible to do any budget or personnel analysis. Fortunately, I was able to find the FY 24 President’s budget request off-line and am sharing it here. The numbers provided there are only accurate as to FY 23 and prior years. The FY 24 numbers relate to the Administration request that was not adopted by appropriators. The relevant budget charts start on page 15 of the text and page 17 of the PDF.
We know the intent is to diminish HHS by nearly 20,000 employees—half from buyouts and other inducements….and half from the RIF. So, net FDA staffing levels are expected to decrease by more than the 3,500.