FDA Matters Blog

STEVEN GROSSMAN 4/25/25 STEVEN GROSSMAN 4/25/25

How Many People Still Work for FDA & Other FDA Thoughts

FDA’s responsibilities have not changed since January 20th. However, its capacity to carry out its duties has been meaningfully reduced by the Administration’s downsizing. We should all be able to agree on that.

It has not been clear how many people still work for FDA after the RIF and voluntary departures. How many employees are left to get the work done? That seems especially important to know[1].

Yet, in the absence of an announcement or the release of budget documents, we have been left in the dark.

I have been working with the assumption that there are 19,500 full-time equivalent employees[2], which is based on extrapolating from older budget documents and reflects the flat taxpayer funding and modest user fee increases in FY 24 and FY 25. My number should be reduced by 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).

That projects to roughly 15,000 remaining employees and is a 20% to 25% downsizing of the FDA workforce. Also, we can reasonably assume there are unfilled vacancies that occurred between July 1 and December 31, 2024. It is unclear if they are included in the 4,500 or are additional to it.

In contrast to my rough calculation of a 20% to 25% downsizing, one news organization is calling it a 15% downsizing of FDA. They did not include voluntary separations because that number has never been announced. Anecdotally, we know there are a lot of voluntary separations, but excluding them makes sense if we do not know whether it is 100 or 1000.

Further, that news organization was working from the Office of Personnel Management’s official FedScope database, which shows the FDA workforce in September 2024 as just under 21,000 (here). That is an official source, presumptively more accurate than mine. However, I cannot reconcile the OPM numbers with any data I have in my files[3]. Using their methodology, FDA might have as many as 17,500 FTE employees remaining.

How many employees are left to do the work is profoundly important. Yet, we have a discrepancy of 2,500 FTE employees between two good-faith estimates!

I am not sure my numbers are right. In fact, I hope that they are way too low.

I am not critical of the other analysis. It is a less speculative than mine and based on better documentation of January 1 staffing levels. However, it probably does not account for other sources of departures and may overstate the baseline headcount.

If somebody has better numbers, please let me know.

False Choices: Priorities Do Not Need to Compete

Based on his recent interview, Dr. Makary believes that the microbiome[4] is the key to many chronic conditions. Coming from a family with a long history of gastrointestinal diseases, this seems plausible, even intriguing.

However, “plausible and intriguing” is a reason to put more resources into a particular area of research……not a reason to put less into other areas that have already proven their value (e.g., cell and gene therapy).

Why would we choose one or the other, rather than pursue both?

The same could be said about two of Secretary Kennedy’s priorities. Why does an autism focus need to be framed in a way that diminishes other areas of research on childhood diseases? Why emphasize chronic disease as if infectious diseases no longer have the power to rapidly reshape human destiny.

To be clear, I favor more attention and investment in the microbiome, autism, and chronic diseases. In the process we should not lessen our efforts on cell and gene therapy, other childhood illnesses, and infectious diseases. We need to be able to find the resources to give proper attention to all of these priorities.

Applying Chesterton’s Fence to Industry Representatives on FDA Advisory Committees

I was quoted in BioSpace, this week, observing that:

Industry representatives on advisory panels do not vote; do not have a professional or monetary interest in the outcome; and have little ability to sway the outcome. Yet, they do provide a useful perspective that other panelists often value. Nonetheless, the appearance is jarring, and it is understandable that questions are being raised.

Missing from my quote and most of the public discussion has been a description of the benefits of including industry reps. Once companies deliver their presentations and answer questions, they must remain silent.

If the committee discussion misstates the company’s data or position, often the industry representative is the one who clarifies the company’s point and gets the advisory committee’s discussion back on track.

I do not see the tide turning in favor of keeping the industry representatives. However, I wish that someone had applied Chesterton’s Fence[5] first: do not take down a fence until you understand why someone put it up.

I have written several times about the other part of the problem: since RIF’s were random and arbitrary, is there any reason to think the remaining workforce has the needed distribution of expertise to match the agency’s responsibilities. https://www.fdamatters.com/fdamatters/rx-for-fda-an-agenda-for-the-commissioner
Full-time equivalent (FTE) is a way to standardize headcounts within a workforce. Two half-time employees equals one FTE.
I wonder if the dramatically higher OPM number counts total employees rather than FTE’s. Or maybe there are one thousand never-to-be-filled slots in the total that are now permanent vacancies.
https://www.niehs.nih.gov/health/topics/science/microbiome#:~:text=The%20microbiome%20is%20the%20collection,our%20bodies%20and%20inside%20us
https://www.fdamatters.com/fdamatters/chestertons-fence-the-meaning-of-deregulation-other-thoughts-about-fda

STEVEN GROSSMAN 4/22/25 STEVEN GROSSMAN 4/22/25

FDA and Politics: An Unhealthy Combination

Dr. Makary is a physician, healthcare quality and outcomes researcher, and self-styled iconoclast. When he accepted the Commissioner position in November 2024, I am sure he believed that Trump 2.0 would be a hospitable place to harness those personal attributes in the cause of a more effective, consumer and patient-focused FDA.

Dr. Makary is a physician, healthcare quality and outcomes researcher, and self-styled iconoclast. When he accepted the Commissioner position in November 2024[1], I am sure he believed that Trump 2.0 would be a hospitable place to harness those personal attributes in the cause of a more effective, consumer and patient-focused FDA.

I am certain, as well, that at that time he would have wholeheartedly affirmed my mantra: FDA will be okay as long as it is committed to incorporating good policy, good medicine, good public health practices, and good science into all agency decisions.

A Lot Has Changed Since Dr. Makary Said “Yes” to Being Commissioner

From the perspective of last Fall, I doubt he anticipated that this Administration would devote itself so vigorously and globally to “norm-breaking.” Or that it would relentlessly pursue its positions with a highly politicized and deeply personal fervor.

Likewise, he could not have foreseen in the Fall of 2024 that the value of public and private investment in life sciences and health would be so dramatically devalued in March and April of 2025[2] or that his staff would be cut by more than 20% via random and arbitrary RIF’s[3]. He could not have foreseen that “radical transparency” would include frequent suspension of the “notice and comment” provisions of the Administrative Procedures Act, which are the bedrock of our government’s commitment to be inclusive of all views.

When Dr. Makary said yes in November 2024, I doubt he intended to fill the agency with political appointees or to politicize agency decisions or to abandon good science.

A Tradition of Keeping FDA Out of Politics

Traditionally—and this is a deeply imprinted cultural norm—the Commissioner stays out of product decisions. And so does the Secretary[4]. Such decisions are made by the center directors, who, to my knowledge, have never been political appointees. Even the center directors have tried their best (not always successfully) to keep the focus on what the review team decides, often with input from an advisory committee.

Product approvals should be based on science, not politics. FDA’s process, while not always perfect, is intended to reinforce that.

So far, no line has yet been crossed in 2025[5]. The three appointments announced this week are known quantities with strong ties to the agency[6].

Nonetheless, pressures are building. The leadership ranks have thinned considerably, and more appointments are coming. Also, presumably, a backlog of decisions has been growing since January.

As far as I can tell, there are no legal barriers to politicization. Specifically, FDA statutory authority is assigned to the Secretary, who has delegated it to the Commissioner, who I believe has delegated certain decisions to the center directors. All of these delegations can be withdrawn, in whole or part, at any time.

All of which is to say: the integrity of FDA and of FDA decisionmaking are at risk. It is up to Dr. Makary to either be the bulwark against politicization….or to defer to his boss and the prevailing ethos of the new Administration.

I am sure that some readers are saying: Steven, why are you putting this in writing? Do not give the new Administration any ideas. To which I can only respond: nothing in this column is a surprise to the Administration, HHS, or FDA.

The issue is whether–despite deeply rooted tradition and good common sense--Dr. Makary and his bosses want to politicize the agency. It is not whether they have the authority or means to do so.

Along with the rest of the stakeholder community, I have a preferred outcome and await evidence of which course of action they pursue.

https://hub.jhu.edu/2024/12/01/marty-makary-fda-appointment/
For example, if one were to believe (I do not) that life sciences should be advanced solely in the private sector and not publicly-stimulated through NIH, then you still need to support FDA. Without an expert and credible FDA with predictable standards and well-understood process, there will not be much private investment in the life sciences.
https://www.fdamatters.com/fdamatters/random-arbitrary-rifs-drive-the-initial-makary-agenda
In the rare instances this has been challenged, it has always been around reproductive issues and products. To the best of my knowledge, it has always been resolved without impacting issues or products beyond reproductive ones.
With the possible exception of one review of a vaccine that is past its PDUFA due date. This is a serious concern, but not sufficient by itself to decide that FDA has been politicized.
https://www.statnews.com/2025/04/22/fda-marty-makary-new-leaders-deputy-commissioner/

STEVEN GROSSMAN 4/17/25 STEVEN GROSSMAN 4/17/25

Leaked FY 26 FDA Budget Document Explained

There is a document widely-circulated this morning that purports to be the OMB passback to HHS of the draft proposed FY 26 HHS President’s budget request. It includes proposed numbers for FDA funding for the coming fiscal year.

It is still subject to negotiation and therefore may change between now and the release of the President’s request. Note that it is not the FY 25 recissions package—anticipated in the next week or two—that would, if enacted, reduce current-year FY 25 funding and make the proposed FY 26 cuts look smaller.

The table (below) compares the FY 26 leaked proposal with the FY23 numbers for the budget authority (BA) portion of FDA funding. This is the non-user fee portion that comes from taxpayer funding[1].

In the aggregate, FDA BA funding in FY 24 and FY 25 (current year) are slightly lower than FY 23. Individual line items varied more, so the comparison with FY 23 should be viewed as illustrative of the general magnitude of proposed changes over a three-year period. They are not definitive, relative to the FY 24 and FY 25 appropriations. In particular, Human Drugs BA spending decreased in FY 24, so that the one-year decrease (compared to FY 25) is not as great as it looks by reference to the three-year decrease.

Based on the text and the table, the following conclusions can be drawn:

I have focused only on the BA appropriations level because user fee funding levels are derived by formula rather than calling for any policy judgment by either the Administration or Congress[2].
There is a statement in the HHS text that these proposed appropriations numbers are sufficient to meet maintenance of effort funding requirements (i.e., permitting user fees to be collected). I have no way to confirm this, but OMB/HHS/FDA have accurate numbers for the necessary amounts. It is, therefore, reasonable to assume their statement is accurate.
I have called into question the long-term prospects for user fees (here). However, proposing sufficient appropriated funding to meet the maintenance of effort requirements in FY 26 suggests that the intent is to at least complete the existing five-year cycle. The real risk in the long-term is to reauthorization in 2027, as reflected by the expressed opposition of Trump/Kennedy to industry funding of some FDA activities.
The overall cut from FY 23 funding levels would be in the vicinity of 17%. I will have more to say about this in my follow-up next week.
The food budget cut is accompanied by reference to moving all routine facilities inspections to the states. The viability of this approach would turn, among other things, on 1/ whether the state contracts would include enough additional dollars to offset increased state costs; 2/ which states have the infrastructure to go it alone; 3/ how much money will be left in FDA for national coordination and enforcement plus reinspections.
There is no funding proposed for buildings and facilities and no monies appear to be allotted for pay increases based on time in grade. (Cost-of-living increases are explicitly rejected). Any such costs will need to be absorbed by FDA within the proposed budget levels.
I have referenced in earlier columns that FDA spends about $2 billion in BA funding on medical products programs. This number is derived from a “major functions analysis” that appears in budget documents in most years. It includes funds that are in every line item—not just CDER, CBER, and CDRH. As a result, the OMB passback numbers do not tell us how much overall medical product spending from BA funds will be cut.
The HHS reorganization document circulated at the same time….is interesting but does not appear to affect FDA or its proposed funding.

If subscribers to “FDA Matters: The Grossman FDA Report” (subscribe on the website at www.fdamatters.com) have additional questions, please send them to me. I will try to answer them via a column early next week.

Note that FDA took all budget documents off their website in late January, making it nearly impossible to do any comparative budget analysis. However, I have the FY 23 enacted numbers, which are accurate, and I am using as the baseline. I have seen analysis that uses the FY 24 baseline, which I believe is also accurate. Using FY 23 vs. FY 24 should not make any fundamental change in my conclusions.
Note that total medical product user fees are derived by excluding tobacco user fees, indefinite user fees, and a smattering of food user fees. The total does appear to increase in FY 26 but only modestly and presumably in line with the amounts called for in the five-year user fee agreements.

STEVEN GROSSMAN 4/15/25 STEVEN GROSSMAN 4/15/25

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 from the agency’s 19,000 employee workforce, it cannot possibly sustain its heavy workload.

Outrage is justified…

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.

STEVEN GROSSMAN 4/11/25 STEVEN GROSSMAN 4/11/25

Chesterton’s Fence: The Meaning of Deregulation & Other Thoughts About FDA

Earlier this week, I posted an “FDA-Related Thought of the Day.” According to LinkedIn, it has generated an astounding 29,796 impressions. That’s a lot more interest than it garnered when I first posted it a month ago (here). Here is what I said:

Earlier this week, I posted an “FDA-Related Thought of the Day.” According to LinkedIn, it has generated an astounding 29,796 impressions (and counting!). That’s a lot more interest than it garnered when I first posted it a month ago (here). Here is what I said (slightly edited):

Understaffed regulatory agencies (i.e., FDA) will tend to say “no” more often because they do not have the staff, time, or focus needed to reach “a nuanced yes.”
Think of the breakthroughs at FDA; think about how much extra time and experienced and well-trained staff were required.

The LinkedIn posting drew a brilliant question (thank you Christy): “Would that still be the case [less capacity for a nuanced “yes”] if an administration has a goal of cutting regulatory burden while also taking savings from cutting staff?”

Here is how I replied (again, slightly edited):

In most cases, the opposite of regulation is not "no regulation" or “deregulation”....it is "less burdensome regulation." You want food to be safe--you can decide some current steps are unnecessary, but history tells us that going to "no regulation" does not deliver a safe food supply. Caveat emptor is rightfully associated with a notoriously unsafe food supply and “anything goes” patent medicines.

Deciding that three checkpoint steps assures safety just as well as five checkpoint steps is important in lessening regulation. However, if it really is "as good," then most of the savings will be on the industry side (two fewer checkpoints), not at FDA where they still need to assure the outcome, such as “a safe food supply.”

"Chesterton's Fence" is metaphor for why you cut regulations carefully: Do not tear down a fence until you know why it was put up to begin with.

That leads to two other points:
1/ you do not cut employees today on the promise of cutting regulatory burden sometime in the future.
2/ government is not a business. But no business would do a large RIF without a plan in place to assure the downsized entity can function. In the DOGE-led downsizing, there is no plan--the RIFs were random and arbitrary.

“Deregulation” and “eliminating regulations” are universally extolled and make great campaign slogans. However, they are just that: slogans.

Rather, “less burdensome regulation” or “lessen the regulatory burden” seem like appropriate goals to me. That allows us to encourage re-evaluation and change in the regulatory environment…while minimizing bad outcomes and not carrying forward the biased assumption that less regulation is always better.

Yesterday, the Administration ordered government-wide wholesale repeal of regulations. To facilitate this, they suspended the requirement for “notice and comment rulemaking” under the Administrative Procedures Act. “Notice and comment rulemaking” is the bedrock of government transparency.

Politico was not impressed. https://www.politico.com/news/2025/04/10/federal-agencies-public-notice-comment-trump-administration-00284499. Nor am I. It reinforces my view that “eliminating regulations” is most-often a slogan rather than a mindful exercise.

Response to Possible/Proposed Massive Reorganization of FDA. The Center for Science in the Public Interest (President Peter Lurie/Director of Regulatory Affairs Sarah Sorscher) posted an insightful critique of the reorganization proposal being circulated by the administration (here).

I reposted it on LinkedIn and added the following thoughts:

“A massive reorganization of FDA—changing functions, philosophy, and process--will endanger consumers and patients, create chaos for industry, and dramatically reduce FDA productivity for months. Therefore, it follows: even if the proposed reorganization of FDA is brilliant (and we can certainly disagree about that), the unknown long-term benefits of such change (5 years?) is unlikely to exceed the extremely high and far more certain short-time costs (2-3 years). Count me as a fan of well-planned incremental changes.”

In turn, the article by the Center for Science in the Public Interest and my comment were reposted by former Commissioner Califf, who observed:

“Hard to tell what is really being planned vs what is being "floated". Transparency would be helpful.”

Response to FDA Commissioner Makary’s Decision to Permit Some Reviewers to Work from Home. Mathew Perrone of Associated Press (AP) reported the story here.

The story quotes me about first steps for Dr. Makary and how “work at home” fits in:

"Dr. Makary needs to rebuild teams and restart the engine of productivity lost to weeks of job insecurity, uncertainty and shortages of team members,” said Steven Grossman, a former HHS official. “Turning commuting time back into work time is a great first step in achieving both.”

STEVEN GROSSMAN 4/7/25 STEVEN GROSSMAN 4/7/25

The Possible Demise of User Fees: Existential Threats Require Outside-the-Box Thinking

Last Thursday, Alec Gaffney of AgencyIQ declared “…the future of FDA’s user fee programs is in extreme jeopardy” (here). Alec has a well-deserved reputation as one of the best FDA analysts. Alec talks; people listen.

For the most part, I agree with him and have been building up to this conclusion since January

Rising Concerns About User Fees Addendum to: “The Possible Demise of User Fees: Existential Threats Demand…”

January 24, 2025 column in FDA Matters: https://www.fdamatters.com/fdamatters/keep-calm-and-carry-on-lessons-from-trump-10

Eight years ago, just before President Trump was sworn in for the first time, I expressed my belief in FDA’s ability to survive change. I wrote:

“Despite the stridency of the rhetoric and the substantial uncertainty about 2017, Republicans and Democrats have, for decades, mutually supported an FDA that is well-functioning and fulfills its incredibly important public health mission.”

It is reasonable to have doubts whether this remains true in 2025.

February 14, 2025 column in FDA Matters: https://www.fdamatters.com/fdamatters/short-takes-and-updatesfebruary-14-2025

1. When Will Congress Engage on the Future of FDA User Fees?

Either the agency is captured by industry (Secretary Kennedy), or it is a hindrance to industry (Vivek Ramaswamy). I understand how it could be neither…but not how it can be both.

The lack of clarity is of concern to nervous corporate executives and many FDA employees. I have pointed out that PDUFA VII and MDUFA V and GDUFA III do not expire until September 30, 2027, with initial discussions only just starting this summer. There is time for this discussion after the new Administration has been in office for a while and taken care of more pressing issues.

I am starting to feel a bit nervous about this answer. So far, the new Administration has shown little patience for waiting on anything. If they feel strongly, they seem to want to engage immediately….contractual agreements and statutes not necessarily representing barriers.

This is not a prediction, just a lessening of my certainty that user fees are off the table until later.

February 18, 2025 column in FDA Matters: https://www.fdamatters.com/fdamatters/if-being-mission-critical-is-not-important-enough-what-is

Government-wide, protecting the more valuable functions of the government (agencies, service and people) formed no apparent part of the employee reductions[1].

It may be crazy to do a RIF at FDA when laid-off employees are mission-critical to medical advances and food safety and play a key role in national and global commerce….

***

In assessing the current situation, I am left with an obvious question that appears to have no immediate answer: if being mission-critical is not valuable enough to save an employee, service, or program, what is?

February 23, 2025 column in FDA Matters: https://www.fdamatters.com/fdamatters/special-edition-fda-rifs-and-user-fees-explained

Footnote 3: To assure that user fees did not supplant BA (appropriated) funding, the user fee laws contain “maintenance of effort” provisions for how much BA money must be appropriated before user fees can be collected. The triggers vary for each program. These “maintenance of effort” provisions are not likely to be triggered by lay-offs but become an issue later if Congress tries to shrink the FDA’s BA budget beyond a certain point. We will address this in a future column if it becomes relevant.

[April 4, 2025, observation: assuming a reasonable amount of bookkeeping flex on BA vs. UF staff, the RIF’s as such do not trigger the crisis. Rather, the triggers become an issues when/if Congress lowers FDA’s BA appropriations, which is likely to be part of an upcoming recission package to be sent to Congress]

March 7, 2025 column in FDA Matters: https://www.fdamatters.com/fdamatters/short-takes-and-updates-march-7-2025

4. User Fees Still Likely to Continue, But Not a Sure-Thing

The process of negotiating the next set of medical product user fees would normally start with some public hearings in the Summer or Fall of this year. That allows enough time to have user fee legislation before Congress by January 2027.

In my Short Takes column of February 14 (here), I suggested that the new Administration might want to begin sooner and have a broader conversation about the purpose and value of user fee programs.

This week, AgencyIQ (in a members-only analysis of recent EO’s and prior RFK, Jr.’s statements) concluded that “user fee programs could undergo major reforms, or even be terminated, during the next reauthorization cycle – all over concerns about undue “industry influence.”

March 27, 2025 story in Roll Call: https://rollcall.com/2025/03/27/targeting-fda-user-fees-would-leave-agency-gutted-experts-say/.

Steven Grossman, a regulatory consultant at HPS Group and author of the FDA Matters newsletter, said in an email to CQ Roll Call that his concerns about the future of the user fee program have grown since the Trump administration took over.

“The risk of dramatically different medical product user fee programs — or none at all — has gone from blue (general risk) to at least yellow (significant risk),” he wrote. “If somebody suggested orange (high risk), I would not say they are exaggerating.”

Writing in a Feb. 14 blog post, Grossman said the process for negotiating the next set of user fee programs would typically start with hearings beginning in the summer or fall, allowing time for the legislation to be drafted by January 2027.

“My hope is that it warns stakeholders not to take renewal for granted,” he said in an email.

April 2, 2025 column in FDA Matters: https://www.fdamatters.com/fdamatters/random-arbitrary-rifs-drive-the-initial-makary-agenda

When you stop trying to rationalize what is going on, you get to the simple but startling truth: random, arbitrary RIF’s are intended to:

1/ destroy government credibility and expertise,

2/ demoralize remaining staff,

3/ make it near-impossible to recruit experts in the future; and

4/ reduce staffing levels to where competent program performance will be challenging if not impossible.

It feels like such a big leap to such a radical conclusion—that the mind wants to deny the possibility.

However, you do not downsize the DOGE way if your only goal is a smaller, more efficient federal workforce that serves the American public and its needs[1].

It was done successfully in the 1990’s with a minimum amount of disruption and only modest RIF’s that were implemented at the end of the process. See my analysis of the “Reinventing Government” initiative.

STEVEN GROSSMAN 4/4/25 STEVEN GROSSMAN 4/4/25

New Administration’s Food Priorities Require Resources, Expertise, and Regulations:Where Will They Come From?

First appeared in Food Safety News. Reprinted with permission.

------------------------------

Secretary Kennedy’ announcement came last Thursday: FDA’s contribution to the pending HHS reduction in force (RIF) would be 3,500 employees. That is not quite 20% of the agency’s total workforce. The RIF would be in addition to an unknown number of FDA employees who have already taken buyouts (voluntary separation).

Random Arbitrary RIF’s Drive the Initial Makary Agenda

In theory, you could RIF 3,500 FDA employees and agree to x number of buy-outs, and still have an agency that could competently carry out a portion of the agency’s vast responsibilities. However, it would be extraordinarily hard to do and impossible without a well-developed plan for what functions can be downsized and which employees eased out.

— Permission is granted to reprint or recirculate this column, as long as
attribution is made to FDA Matters (www.fdamatters.com) and the author. —

Smaller government is possible, albeit not always warranted. In theory, you could RIF 3,500 FDA employees and agree to x number of buy-outs, and still have an agency that could competently carry out a portion of the agency’s vast responsibilities. However, it would be extraordinarily hard to do and impossible without a well-developed plan for what functions can be downsized and which employees eased out.

On the other hand, if the RIF’s are random and arbitrary, which seems to be the case, then we should stop wasting our time trying to understand the Administration’s RIF/downsizing strategy:

Random arbitrary RIF’s do not make any sense; by definition, they cannot.
There is no actual plan, only slogans about downsizing government, saving taxpayers’ money, and eliminating people who are allegedly overpaid and underperforming.
Government is not a business. But even if it were, no company would downsize without a plan for staying in business afterward (or a plan for liquidation).
The current effort is not the only way to downsize government (my summary of the 1990’s effort here concludes that “federal employees would support downsizing if it is planned, paced, and predictable.”)
Random arbitrary RIF’s is not an efficient or appropriate way to address the problem of large, unsustainable government deficit spending (my budget reconciliation primer).

When you stop trying to rationalize what is going on, you get to the simple but startling truth: random, arbitrary RIF’s are intended to:

1/ destroy government credibility and expertise,

2/ demoralize remaining staff,

3/ make it near-impossible to recruit experts in the future; and

4/ reduce staffing levels to where competent program performance will be challenging if not impossible.

It feels like such a big leap to such a radical conclusion—that the mind wants to deny the possibility.

However, you do not downsize the DOGE way if your only goal is a smaller, more efficient federal workforce that serves the American public and its needs[1].

What Comes Next?

In my RIF FAQ, I discussed the need to protect “review teams” and “inspection teams” and not just reviewers and inspectors. Preliminary, possibly unreliable reports suggest that the reviewers did okay and the inspectors not so much. Even with reviewers, however, I doubt that the teams were defined broadly enough to keep functions intact and unaffected.

Thus, the single most pressing priority for Commissioner Makary is figuring out what FDA can still do, given a workforce that is at least 18% smaller through RIFs and closer to 23% smaller if voluntary separations and buy-outs are included. 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.

This assessment is far more complicated than it might seem. In an earlier column, here, I pointed out that employees are divided into a large number of job categories that reflect education and experience. A PhD biochemist, a biostatistician, a consumer safety officer, a communications specialist, and a laboratory technician are not interchangeable.

Further, funding sources are not always interchangeable. While there is no such thing as a user fee employee (FDA, Lay-offs, and User Fees Explained), an employee’s salary and benefits can only be paid by user fees if their responsibilities are creditable as fulfilling a user fee supported activity.

After realigning functions and teams (by matching responsibilities with available personnel), 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 now. It will take time for teams to re-form and work-arounds figured out. Then it will take still longer for productivity to even approach former levels.

This is far, far from a full list of what will need to be done. Even my limited list presumes that “humpty-dumpty” can be put back together again.

A Thought on Commissioner Makary’s Situation

FDA needs to be able 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 re-create the the most effective FDA he can. As appropriate, we all need to be rooting for him and contributing to his efforts to restore FDA’s credibility as the world’s premier food and drug regulator.

———————————————-

The post-RIF world of FDA will provide many more twists and turns….and I will be offering analysis and insight on an ongoing basis.

If that is valuable to you, please go to www.fdamatters and sign up. As a subscriber, you will receive columns when published….and not have to wait for them to wander randomly into your social media feed.

It was done successfully in the 1990’s with a minimum amount of disruption and only modest RIF’s that were implemented at the end of the process. See my analysis of the “Reinventing Government” initiative.
I am hearing that there are more RIF’s coming, maybe later this week or next week. I view this as plausible but unsubstantiated. If true--and the names are not already determined--then it is an opportunity for Dr. Makary and his team to think strategically and practically about maintaining functional teams.
We have heard 900 to 1000 buy-outs, but we have no way to verify the accuracy of that number.

STEVEN GROSSMAN 3/29/25 STEVEN GROSSMAN 3/29/25

You are Entitled to Your Own Opinions, But Not to Your Own Facts

If things went really bad at FDA, who would still be there at the end—caring enough about the agency and public health to keep fighting? My answer would be Dr. Peter Marks. I know you would agree.

Peter has been grace and integrity personified, as well as a defender of our collective faith in the value of data and science. Human betterment has always been Peter’s goal, regardless of where it led him. We should all adopt that same goal and that same attitude.

Peter’s leadership has spanned pandemic response, biotechnology, cell and gene therapies, blood products, rare diseases, regulatory science, vaccine development, and myriad other areas.

Read more…

— A Tribute to Dr. Peter Marks —

If things went really bad at FDA, who would still be there at the end—caring enough about the agency and public health to keep fighting? My answer would be Dr. Peter Marks. I know you would agree.

Peter’s leadership has spanned pandemic response, biotechnology, cell and gene therapies, blood products, rare diseases, regulatory science, vaccine development, and myriad other areas.

If something was a good idea—his or someone else’s—he has always been willing to pursue it. If you spoke, you always felt that Peter heard you, whether or not he agreed with you.

FDA is immeasurably worse for Peter’s departure, as are the American people. I worry—and you should too—that this is a harbinger of FDA’s fate: to be judged by individuals who do not believe in its fundamental purpose.

I do not think the details of Peter’s resignation matter. We can be fairly sure that he was asked to agree to some action—a statement, advice to the American people, or some study protocol—and felt his attempts to find common ground were not reciprocated. He refers to a commitment to truth and transparency and it is clear that he and the Secretary see these differently.

This was the culmination of a very bad week for FDA. I see two pressing needs.

First, it is important for FDA stakeholders to advocate for agency leadership that is empowered to act in the best interests of the American people. They need to be able to incorporate good policy, good medicine, and good science into agency decisions.

This falls to Commissioner Makary. He has been dealt a terrible hand, but that is all the more reason for him to act decisively to re-establish FDA’s credibility.

Second, the agency is being shattered by a RIF, made worse by the apparent absence of a plan to carry out FDA’s responsibilities with dramatically fewer staff. In a column yesterday, FAQ on FDA and the RIF, I pointed to a number of concerns that need to be addressed. It is particularly important to protect “review teams” and “inspection teams,” rather than just reviewers and inspectors. On this point, I said:

“…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 processing, analyzing, and acting upon the inspector’s findings.”

The political landscape is such that it is unclear how to get things changed, with whom you have to speak, and with what message.

Let us pursue this, as a community, in the spirit that Dr. Marks has shown us—determined, caring, reasoned, unshrinking, and heedless to the odds when there is a right thing that needs to be done.

STEVEN GROSSMAN 3/28/25 STEVEN GROSSMAN 3/28/25

The HHS RIF: Frequently-Asked Questions About FDA

Steven answers questions about the FDA RIF:

Relative to the FDA workforce, how big is the RIF?

Will the RIF exemption be “reviewer” or “reviewer teams,” “inspectors” or “inspector teams?”

Will so-called “user fee employees” be protected from the RIF?

and more on FDAMatter.com today! https://www.fdamatters.com

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.

STEVEN GROSSMAN 3/25/25 STEVEN GROSSMAN 3/25/25

Three Historical Forces Clashing Over the Future of American Government

This past Friday’s column--“What’s Happening to FDA Employees: An Analogy Can Help” (here)—was one of my most widely-read articles. While the analogy helped many readers, the most important thought was in the last paragraph:
The key learning from the 1990’s [government downsizing] is that most, if not all, federal employees would support downsizing if it is planned, reasonably paced, and predictable. The current effort is just the opposite in all three regards.

Read more…

—A Follow-Up to “What’s Happening to FDA Employees: An Analogy Can Help”—

This past Friday’s column--“What’s Happening to FDA Employees: An Analogy Can Help” (here)—was one of my most widely-read articles[1]. While the analogy helped many readers, the most important thought was in the last paragraph:

The key learning from the 1990’s [government downsizing] is that most, if not all, federal employees would support downsizing if it is planned, reasonably paced, and predictable. The current effort is just the opposite in all three regards.

Over the last few days, I have been asked if I could explain how the political dynamics of 2025 differ from the 1990’s. My answer turned out to be much broader than the question. Here is my take:

In general terms, there are three forces:

those who believe government is a positive force much of the time (pro-government)
those who think government is needed but should be narrower in its scope than it is today (restrained government)
those whose goal is to marginalize government in order to elevate personal and economic liberty (anti-government).

Note that FDA’s status as a core government function is likely to be viewed differently by each.

To be clear, these are generalizations, and any individual might reflect more than one view, depending on the issue and circumstance.

The first and second group (pro-government and restrained government) had common cause in the successful Clinton “reinventing government” downsizing effort in the 1990's. The goal was for government to be more efficient, and each group could see how it served their purposes[2][3]. My recollection is that anti-government forces had no traction in that process, but a more careful reading of the history might come to a different conclusion.

In 2025, the third group (anti-government) is in charge and the second group (restrained government) is being co-opted by them. The first group (pro-government) is in total disarray.

Reflecting the origins of the US as thirteen individual states breaking away from a tyrannical world super-power, the first 150 years of our government’s history can be seen as a clash of anti-government and restrained government forces. The observation “that government is best which governs least” was written by Henry Thoreau, but often mis-attributed to Thomas Jefferson because the sentiment so nearly reflects Jefferson’s (and the Founding Fathers’) views.

It is only since the end of the Gilded Age[4], that a series of Presidents (starting with Teddy Roosevelt) and reformers (like Upton Sinclair, whose exposes created the impetus for what became the FDA) have massively shifted power from private hands to government.

The rationale for this shift in power has become so embedded in our thinking that many of us find it near-impossible to imagine the world of the Gilded Age with no FDA and only occasional and tepid state laws against adulteration of food and drug products

Despite that, a modern anti-government movement exists. As has been pointed out to me, it started with Barry Goldwater and was made legitimate by Ronald Reagan. Reagan’s 1981 Reconciliation package was as far-reaching as any that has come since.

The DOGE purges are Reagan’s dramatic, “first year in office” firing of air traffic controllers, albeit taken to a level beyond anything I think Reagan would have considered. He tended to make his point and move on.

In sum, the Clinton effort and the current Trump effort can be understood together, but only in the context of greater historical forces that have been active in the US since the time of King George III. If history serves as a guide, reactions and counter-reactions are still to come.

The most widely read, by far, was https://www.fdamatters.com/fdamatters/special-edition-fda-rifs-and-user-fees-explained, in which I helped readers and reporters understand why “user fee employees” could be laid-off.
It has been suggested that three trends made the process easier: the efficiencies possible from incorporating the then-new Internet into government work; a declining annual federal deficit; and the “peace bonus” from the end of the Cold War.
FWIW: it may be a total coincidence that the decade of Clinton’s reinventing government ended with four years of budget surpluses. https://www.thebalancemoney.com/us-deficit-by-year-3306306
https://www.investopedia.com/gilded-age-7692919

STEVEN GROSSMAN 3/21/25 STEVEN GROSSMAN 3/21/25

What Is Happening to FDA Employees? An Analogy Can Help

The Federal Workforce is Large….FDA’s Is Small But Important
Deficit Reduction Will Reduce the Federal Workforce….FDA Is Affected But Not Specifically Targeted
President Clinton Significantly Reduced the Federal Workforce…But This Is Different

The MAHA Challenge: Can It Lead to a Healthier and Safer Food Supply?

Let us agree at the outset that food policy and regulation is too important to be ignored. After all, every American ingests food multiple times each day. Nothing else is such a ubiquitous part of our lives.

So, I am fully committed to the value of a major government initiative to improve our food system. It should advance all three of FDA’s primary food responsibilities:

assuring a safe food supply;
protecting us from any harmful food chemicals (additives); and
furthering research and educating Americans to eat nutritiously[1].

So far, HHS Secretary Kennedy’s MAHA (Make America Healthy Again) Initiative is off to a fast start. In the context of addressing chronic disease in children, the topics for the first meeting with “MAHA mothers” were 1/ nutrition, 2/ physical activity, 3/ over-medicalization and standards of care, and 4/ environmental impacts.

On a separate front, Secretary Kennedy met with a few major food companies and delivered the message: “get synthetic dyes (and other controversial ingredients) out of your food, or the government will crack down[2]” (here). He made a short video about the meeting (here).

In a general sense, all of this is good because it puts a spotlight on the neglected area of food policy and regulation. It should stimulate worthwhile changes in our food system and in our health.

As a movement, MAHA is relatively young, so it is a particularly good time to raise questions that need to be addressed. Here are two of mine (more to come in future columns):

Does MAHA Include Continued Support and Investment in a Safe Food Supply? As I pointed out in a column last week, greater attention to chronic diseases is compelling, but it shouldn’t be at the expense of our investment in acute conditions and prevention (here). Similarly, attention to food chemicals and nutrition (collectively, healthier food) is compelling, but it should not be at the expense of our investment in food safety.

Foodborne illness is an ever-present risk. We cannot let our guard down.

Will MAHA Incorporate Both Supply and Demand Approaches to Achieving Healthier Foods? Companies stay in business by supplying the market with products that people want to buy that can be sold at prices that people are willing to pay. They would go bankrupt otherwise. At least in the food space, corporate decisions are top-down, but based on focus groups, taste testing, consumer trends, and sales tracking (i.e., information about individual preferences).

Which is to say, we cannot hope to have people consume healthier foods if we ignore the pivotal role of bottom-up individual decisions (demand) based on taste, convenience, accessibility, cost, and other factors. People tend to talk about wanting to eat healthily, then ignore opportunities to do so. We need to accept Pogo’s admonition that: “we have met the enemy, and they are us.[3]”

Realistically, we need the food industry to offer healthier foods…and we need consumers to purchase healthier foods. Focusing just on businesses (supply) or consumers (demand) will not move the needle. Let us find strategies that help us do both.

A healthier and safer food supply is both politically and substantively possible. We have a head start: a decade of industry/consumer goodwill in the food area that has accumulated as part of the implementation of the Food Safety and Modernization Act (FSMA).

As Executive Director of the Alliance for a Stronger FDA (a post I held until a few months ago), I witnessed two particular examples. First, industry and consumer groups worked together to rally support for strengthening FDA’s relationships with state food and agriculture agencies.

Second, I saw a groundswell of support for FDA to expand its investment in evaluating food chemicals. Groups that were fighting each other in state courts were, nonetheless, in agreement that FDA needed the resources to “up its game” in this area.

This is not necessarily a full list of FDA’s food responsibilities, and it does not include the responsibilities of the Center for Veterinary Medicine. However, it mirrors the three operating divisions within the FDA Human Foods Program https://www.fda.gov/about-fda/fda-organization/human-foods-program.
This and many of the other details are from Helena Bottemiller Evich’s Food Fix column on March 14. For those trying to follow the MAHA effort, her Friday newsletters (free) are indispensable. You can get an even more robust picture by subscribing to her Tuesday newsletter. It is well worth the cost. Her website is www.foodfix.co.
Walt Kelly created the quote and used it in his comic strip on the first Earth Day in 1971. It later became a famous poster. “The quote used as the poster’s headline is still famous today — and the concept embodied in the poster still holds true. We cannot just blame the big bad corporations for the environmental problems we face. Most of the time, they are just giving us what we “demand” as consumers at a cost we are willing to pay and abiding by laws created by politicians we elect. We all need to our own small part, as consumers and voters.” https://www.thisdayinquotes.com/2022/04/we-have-met-the-enemy-and-he-is-us/

STEVEN GROSSMAN 3/14/25 STEVEN GROSSMAN 3/14/25

Short Takes and Updates—March 14, 2025

Zero-Based Defense (ZBD) of Critical Government Programs
Passage of FY 25 CR: FDA Level-Funded But Other Programs Hit
Multiple Budget Battles Yet to Come: FDA at Continued Risk
What I am Reading: Proposed Cuts to Medicaid

1. Zero-Based Defense (ZBD) of Critical Government Programs

In the March 12 FDA Matters blog (here) I observed that incoming leaders during a government transition are likely to think: if it looks easy, then it must be easy. Program success is likely to be unappreciated and resource needs taken for granted.

My advice: prepare a zero-based defense of the federal role in your area and the resources required to ensure that the activity continues to be successful. As explained in the footnote, this is similar but broader than zero-based budgeting. I would be happy to discuss this with any organization thinking about this approach and would be available to support your efforts.

2. Passage of FY 25 CR: FDA Level-Funded But Other Programs Hit

Later today, the Senate is expected to adopt the FY 25 Continuing Resolution passed by the House earlier this week. The House bill would fund the government through September 30, the end of fiscal year.

FDA was level-funded, which is an excellent result under the circumstances. On the other hand, the Department of Defense Congressionally Directed Medical Research Programs was cut by $859 million, or 57% (here and here). The District of Columbia budget was also cut by a billion dollars.

For those trying to figure out the fast-moving politics: Speaker Mike Johnson managed to accomplish something his predecessors were unable to do: move a Republican spending bill through the House without Democratic support. He then recessed the House until March 24. That forced the Senate to either adopt the House bill or allow a government shutdown. This morning’s Roll Call provides an excellent analysis of how Senate Democrats were out-maneuvered.

3. Multiple Budget Battles Yet to Come: FDA at Continued Risk

FY 25 CR is the very beginning of budget fights. Congress can now turn its attention to reconciliation, recissions, debt ceiling, and the FY 26 appropriations cycle.

In addition, there is a strong possibility that the President will try to impound funds appropriated in the FY 25 CR. Ultimately, the Supreme Court will decide whether impoundment violates the Constitution.

I anticipate that Congressional Republicans will try to avoid a showdown by passing legislation that parallels the impoundment. They would then try to run the political and procedural gauntlet that they just accomplished with the FY 25 CR.

4. What I am Reading: Proposed Cuts to Medicaid

Two new studies have been released on the consequences of deep cuts contained in the House-passed budget resolution, which is a blueprint for reconciliation. Medicaid, the Children’s Health Insurance Program (CHIP) and Medicare will need to generate program savings between $600 and $880 billion over the next 10 years (New York Times). The Congressional Budget Office has concluded: that level of savings is not possible without large cuts to those three programs (Washington Post).

In the March 8 edition of MedPages (here), Dr. N. Adam Brown points out that:

While 80 million Americans are insured through Medicaid, many people don't think of themselves as "on Medicaid" -- even when they are.

Why? Because Medicaid is not branded as Medicaid in most states. If you tell a patient in South Carolina, they might lose Medicaid, their eyes may glaze over. Tell them Healthy Connections is at risk? You have their attention.

Such large Medicaid and CHIP cuts, combined with cuts in medical research and support for academic medical centers, will have a significant impact on our health care system.

Eventually, there will be downstream impacts on FDA’s food, nutrition, and medical product responsibilities. I will explore this topic more fully in a future column. As just one example, if the Administration is consistent in their positions, there will be an open door at FDA for Rx-to-OTC switches.

5. Pass the word: sign-up to receive FDA Matters.

Forward this e-mail to colleagues and friends and urge them to subscribe at www.fdamatters.com.

“Zero-based budgeting” often starts with the implicit assumption that something is needed, and the goal is efficient use of manpower and budget to achieve specified outcomes. Internal consensus is often all that is required.
What I am proposing is a bit broader: establishing a zero-based rationale for why anything is needed from any specific level of government, as well as how to successfully and efficiently deliver relevant and needed outcomes. The analysis must be capable of being communicated to external audiences whose buy-in is required.
Zero-basing analysis of FDA (which I am not suggesting is needed) would, therefore, start with establishing whether safe food and drugs needs government oversight (which we all take for granted), rather than starting with how that function can be performed most efficiently.
Impoundment is unilateral action taken by the executive branch to delay or cancel appropriations enacted into law. Generally, Congress and the courts have found impoundment unlawful. For more background: start here with the PBS explanation. More detail can be found here.

STEVEN GROSSMAN 3/12/25 STEVEN GROSSMAN 3/12/25

What I Learned By Speaking About “FDA in Trump 2.0”

On Monday, I had the honor to address the annual meeting of America’s Blood Centers (ABC). It reminded me how much I learn by preparing for speeches and panels.

From this current effort, I have three main take-aways to share, each quite different from the other:

Understaffed regulatory agencies (i.e., FDA) will tend to say “no” much more often if they do not have the staff, time, or focus needed to reach a nuanced “yes.” Think of the breakthroughs at FDA; think about how much extra time and staff those have required.

Short Takes and Updates—March 7 2025

Taken From This Week’s Headlines
Makary Makes Commitments to Senators and Other Observations
March 14 Government Shutdown Cannot Be Ruled Out
User Fees Still Likely to Continue, But Not a Sure-Thing
What I Am Reading: More on Extending Health Lifespans
What I Am Listening to: FDA Watch/The Evolution of Clinical Trials
and more…

If you have not signed up to receive the FDA Matters newsletter in your email box, go to the home page to sign up.

1. Taken From This Week’s Headlines

Elon Musk learns there is a Budget Control Act protocol, known as recissions, for cutting appropriated funding. He just needs to talk with Congress. (Roll Call March 6 2025)
Per Trump: Cabinet Secretaries, Not DOGE, Decide Agency Lay-Offs. (Federal News Network March 4) (Politico March 6).

2. Makary Makes Commitments to Senators and Other Observations

The purpose of most confirmation hearings is for Senators to gain commitments from nominees that restrict their decisions once in office. (see Lessons from Dr. Gottlieb’s 2017 Confirmation Hearing).

That was in full display at Dr. Makary’s hearing where practically every question contained the phrase: “...will you commit to taking this specific action?” and many of the answers contained the phrase: “….I commit to take the following action.”

Also, it was clear why nominees are never made “acting” in the post to which they are nominated. It allowed Dr. Makary to say: “I had no prior knowledge of the lay-offs” and “I was not consulted about the cancellation of the flu vaccine meeting.” As far as I know, completely honest answers, but also effective in diffusing some of the most potentially difficult questions.

Overall, Dr. Makary answers reflected his intelligence and quick mind. On some points, I agreed with what he said and on others I have serious concerns.

One of his comments was misleading. In parrying a question about the lay-offs at FDA, Dr. Makary noted that the agency staff had doubled since 2007, implying that maybe the agency had grown more than it needed to. Even if it is true that staff doubled[1], it should not be a surprise since–in this same time period–the agency’s budget more than doubled and the agency’s responsibilities multiplied and became far broader and more complex. This illustrates why the FTC (and FDA) advertising standard is that “statements must be truthful and not misleading.”

3. March 14 Government Shutdown Cannot Be Ruled Out

The FY 25 Continuing Resolution only funds government until next Friday (March 14). Supposedly, a deal is in the works that would cover the remainder of the year. If not, maybe Congress will pass another short-term CR. It is unlikely but still possible that we could have a government shutdown.

As the deadline draws near, there are likely to be reports that about 75% to 80% of the FDA workforce will still be on the job because of various public health and safety exemptions and the availability of user fees.

However, that assumes the Trump Administration will utilize the existing FY 2025 contingency plan (as of last October 1) and make minor adjustments for lay-offs. Plans from a decade ago retained many fewer employees than the 2025 plan. There is a non-zero chance that the Administration chooses those earlier (lower) levels to reinforce their “smaller government” theme.

4. User Fees Still Likely to Continue, But Not a Sure-Thing

In my Short Takes column of February 14 (here), I suggested that the new Administration might want to begin sooner and have a broader conversation about the purpose and value of user fee programs.

5. What I Am Reading: More on Extending Health Lifespans

If you were intrigued by last week’s column (here) on extending the span of life free of chronic diseases and disabilities, you can find more on the topic at: Healthy Longevity For All | The Kitalys Institute and Home | Targeting Healthy Longevity. If you want to read the transcript of last Friday’s webinar on FDA and the development of so-called “healthspan” products, the transcript can be downloaded here.

6. What I Am Listening to: FDA Watch/The Evolution of Clinical Trials

Shelly Garg and Wayne Pines’ FDA Watch Podcast featured me and Anthony Brogno of Lindus Health. You will hear our thoughts on how drug development, drug approvals, and clinical trials could be evolving under the new administration, and much more. You can listen to the podcast here.

I could not confirm the number of staff in 2007 because FDA budget documents have been taken off the agency site and apparently have not been restored.

STEVEN GROSSMAN 3/4/25 STEVEN GROSSMAN 3/4/25

Lessons from Dr. Gottlieb’s 2017 Confirmation Hearing

President Trump nominated Johns Hopkin Professor Martin Makary to be the next Commissioner of FDA. His confirmation hearing is Thursday, March 6 at 10 a.m. The livestream will be here.

As with confirmation hearings generally, the ostensible purpose is to determine Dr. Makary’s fitness to be FDA Commissioner. I expect the Senate HELP committee to conclude that he is qualified. The Senate should confirm him in March or early April…

If you have not signed up to receive the FDA Matters newsletter in your email box, go to the home page to sign up.

President Trump nominated Johns Hopkin Professor Martin Makary to be the next Commissioner of FDA. His confirmation hearing is Thursday, March 6 at 10 a.m. The livestream will be here.

A confirmation hearing is a lot of work for Senators and staff, just to prove Dr. Makary is qualified…something everybody knew beforehand. He is qualified. Why bother with a hearing?

Historically, the real purpose of confirmation hearings is for Senators to extract commitments from nominees that narrow what they can do once in office[1]. Those can be:

relatively benign, such as Dr. Gottlieb agreeing in 2017 to review “a persistent issue with the FDA not properly clearing medical device shipments” or
incredibly divisive, such as FDA’s role in the accessibility of mifepristone, the key component of medical abortions.

All this week you will see articles like: “the five questions that I want Senators to ask Dr. Makary” and “the five toughest questions that Dr. Makary will face.”

Instead, this column goes back to look at Gottlieb’s confirmation hearings in April of 2017—suspecting there will be parallels to what Dr. Makary will face on Thursday.

Gottlieb Confirmation Hearing (2017). Scott Gottlieb Confirmation Hearing Transcript

Senate Outcome: Confirmed 57 to 42 on May 9, 2017. Republicans were in the majority and all voted yes. They were joined by Democratic Senators: Bennet, Carper, Coons, Heitkamp, King (Independent), and Nelson. The forty-two nay votes were all Democrats.

At the confirmation hearing, Gottlieb received a positive introduction by his home state Senator (Chris Murphy), who subsequently voted against him.

Parallels Between 2017 and 2025: Dr. Gottlieb was nominated at the beginning of President’s Trump’s first term. In both years, the Senate was closely divided with a slim Republican majority.

Many of the same issues that concerned Senators then, still concern Senators today: abortion, tobacco, women’s access to birth control, opioids, trial design and standards, biosimilars, off label marketing, pandemic preparedness and medical counter measures, and close ties between FDA and regulated industries…just to name a few. The most frequently discussed issues were 1/ opioids, pain, and addiction, and 2/ health care costs, generics, biosimilars. It will be interesting to see if these are still the top priorities.

The testiest exchange was probably Senator Bernie Sanders trying to extract a commitment from Dr. Gottlieb to support drug re-importation, to align himself with a Trump campaign promise to advance re-importation (pages 17-18 of the transcript).

Most Unexpected Finding: I had forgotten the chaos and norm-breaking that occurred in 2017. There is an eerie similarity to today. In her opening remarks at the hearing, Ranking Member Patty at Murray challenged Dr. Gottlieb to be more forthright “Given the Trump administration’s clear willingness to skirt ethics’ rules and pressure Federal employees to jam their policies through….” (page 4 of the transcript).

Implementation of New Laws Can Stretch into Decades. Senators were interested in how Dr. Gottlieb intended to implement the Drug Quality and Security Act of 2013 (DQSA), the Biologics Price Competition and Innovation Act of 2010 (BPCIA), and the Food Safety Modernization Act of 2010 (FSMA). While there has been much progress since 2017, all of these complex laws still have implementation issues that may well come up at Dr. Makary’s confirmation hearing.

The Most Important Exchange (from Ranking Member Patty Murray)(page 4 of the transcript):

Dr. Gottlieb, in the limited time we have had to review your professional history and background, I have grown increasingly concerned about whether you can withstand political pressure pushing you to ignore science by upholding the gold standard, and if you can lead the FDA in an unbiased way, given your unprecedented industry ties.

Dr. Gottlieb’s response (in his testimony) (Page 8 and 9 of the transcript)

If confirmed, I will lead the FDA as an impartial and passionate advocate for public health. I know what is at stake here. People’s lives are literally on the line when it comes to the decisions FDA makes, its oversight, and its enforcement of Congress’ laws.

The American people deserve to trust that the agency is led in an impartial manner—guided only by the science that informs its work—and an abiding faith to the public health.

That is the mandate by which I would lead this agency, if I were fortunate enough to win your approval. I will respect the intent of Congress. I will make sure the laws you passed are implemented in a timely fashion and in the way you intended.

Every decision I make will be guided by the advice of career experts. I will be guided by the scientific rigor that the public deserves, and the rigor that the hard challenges before this agency demand. It is to take on these challenges that I seek this role.

The FDA stakeholder community will respond with cheers and a deep sigh of relief if Dr. Makary makes the same assurances.

It is acknowledged that—at least so far--- this year’s batch of nominees seem to be less concerned about fulfilling commitments made to Senators during their confirmation hearings.

STEVEN GROSSMAN 2/27/25 STEVEN GROSSMAN 2/27/25

Fresh Thinking: Extending Healthy Lifespans

I never intended FDA Matters to focus only on the new Administration or on existential threats to FDA. Nonetheless, that is mostly what you have gotten from me since we launched on January 10.

I need a break. Maybe you do, too? Let’s talk instead about living longer and healthier…

LIVE EVENT!

Come join us tomorrow, (Friday, February 28) at 11 a.m. ET to discuss the need for a regulatory pathway to enable the development of products that extend the span of life free of chronic diseases and disabilities

https://www.eventbrite.com/e/draft-healthspan-legislation-the-thrive-act-tickets-1246559596309

I never intended FDA Matters to focus only on the new Administration or on existential threats to FDA[1]. Nonetheless, that is mostly what you have gotten from me since we launched on January 10.

I need a break from politics. Maybe you do, too? Let’s talk instead about living longer and healthier.

This Friday (February 28) at 11 a.m. ET, I am going to be part of a web event to discuss the proposed THRIVE Act. The bill (and the event) is a first step in initiating a national discussion on how to enable the development of products that extend healthspan, the span of life free of chronic diseases and disabilities.

I applaud Kitalys Institute and the bill’s champions[2] who have raised valuable questions and developed a foresightful approach to the collective toll of chronic diseases of aging.

Those who reach their seventies are likely to live longer and in much greater numbers than ever before. Will those later years of life come at great personal and societal cost….or be the wonderful and productive years that we all wish for? Can we stimulate innovation in the discovery and marketing of drugs, vaccines, devices, OTC medicines and other products that will slow, and in some cases may completely prevent, the accumulation of chronic diseases?

Creating a pathway for such products is a cause that deserves the attention of policymakers and bold action on the part of our elected leaders. This should be a bipartisan effort, but someone needs to step up to champion it.

Secretary Kennedy, are you listening?

FDA reviews drugs, biologics, vaccines, and medical devices that treat diseases and medical conditions. A small but important segment, notably vaccines, helps prevent specific diseases[3].

The FDA is good at this. That, in turn, has stimulated an innovative biopharmaceutical and medtech environment that has made great strides in treating and preventing diseases[4].

However, looking beyond that, there is no regulatory pathway for healthspan products that addresses the goal of healthy aging and prevention of multiple chronic conditions. Such products do not fit the prevailing disease model of medicine. Plus, importantly, it is not realistic to run 20-year long trials with control groups and pre-specified endpoints.

The THRIVE Act is aimed at encouraging the development of products that prevent multiple chronic diseases and lays out a regulatory pathway that could work. I am told that discoveries from the field of geroscience, (the field that studies the biology of aging), suggest that the major chronic diseases share root causes in the aging process. Based on that insight, we can hope to find single drugs or other products that slow the aging process and delay the onset of multiple chronic diseases, including diabetes, cardiovascular, and neurodegenerative diseases.

If we want healthspan products—and want to delay and prevent chronic diseases of aging—then an appropriate and realistic regulatory pathway is needed.

Build it and inventors and investors will come!

I expect a lively discussion on Friday. Come join us for this kick-off event and the beginning of a movement to find new ways of addressing chronic diseases.

Join us for the web event at: https://www.eventbrite.com/e/draft-healthspan-legislation-the-thrive-act-tickets-1246559596309

For more background, go to https://www.linkedin.com/posts/thomasseoh_healthcare-healthspan-fda-activity-7296924407577362432-EvNq/

Please join us on Friday. Do not wait for the book and movie versions!

–Steven

I created FDA Matters to be a platform for a variety of FDA topics, such as food safety, biomedical and MedTech innovation, orphan drugs, and other policy interests of FDA and its stakeholder community.
This is an effort championed by the non-profit Kitalys Institute (www.kitalys.org) and its three co-founders: Alexander (Zan) Fleming, Founder of Kinexum and formerly FDA’s lead reviewer on a number of drugs for metabolic diseases; David Fox, a Partner at Hogan Lovells and former Associate Chief Counsel at FDA, and Thomas Seoh, CEO of Kinexum.
Prevention has largely been confined to infectious diseases. Statins, which prevent cardiovascular disease, provide one of the very few examples of a drug class that prevents chronic disease. More recently, the GLP-1 drugs have also been shown to prevent cardiovascular disease in people with diabetes or obesity. These are the exceptions, not the rule, in preventing the major causes of death and disability in our country today.
I often ask audiences: why didn’t the original Medicare (1965) include coverage for pharmaceuticals and medical devices? Sixty years ago, neither field was far enough advanced to be considered integral to disease prevention or good health. I promise future columns on how ODA, Hatch-Waxman, and other game-changers have contributed to the success of our current medical products innovation ecosystem.

STEVEN GROSSMAN 2/25/25 STEVEN GROSSMAN 2/25/25

Short Takes and Updates—February 25, 2025

FDA Matters, The Grossman Report latest edition: Never Lose the Whip Count, The Disconcerting Consequences of Lay-Offs By Fiat, and User Fees and Lay-Offs at FDA. Read more…

If you have not signed up to receive the FDA Matters newsletter in your email box, go to the home page to sign up.

1. Never Lose the Whip Count

Today (or this week’s) House vote on the reconciliation budget is likely to be one of the most momentous votes in my lifetime in DC[1]….and also one of the most interesting.

When you are the majority legislative party, you are never supposed to lose floor or committee votes. Some of the reasons: party loyalty, shared ideology, and common approach to policymaking. However, the most important reason is that you control when votes occur and you never schedule one until you know you have the votes to win.

The Speaker of the House has a network of “whips” whose job is to find out whether their Members intend to vote the party line. The axiom: the speaker should always know the whip count[2].

Going into the budget vote, the Speaker has a narrow margin for victory. If Democrats are in full attendance and all vote “no,” then he can lose only one vote[3]. Depending on what pundit you read, the Speaker is probably 8 to 12 Republican votes short.

The politics of the situation are more interesting than his merely “not having the votes.” One to four of the possible no-votes are budget hardliners who want a commitment to more spending cuts than even the dramatic levels already contained in the reconciliation resolution before the House.

Most of the potential no-votes are the opposite: Republican centrists whose Congressional districts contain large Medicaid and SNAP populations that also voted for Trump[4].

This is the interesting part for the centrists: if they vote against the reconciliation resolution, they will probably be “primaried” in 2025 and lose their seats even before the general election. If they vote for the reconciliation resolution, they will face an angry electorate of former Medicaid patients and SNAP recipients and probably not be re-elected.

As of mid-morning, I am hearing that Speaker Johnson’s posture (“no changes”) may be softening as they attempt to find compromises on types of Medicaid changes that would be in play. There also appears to be talk of finding additional revenue (from tariffs?) to lessen the dollars that would need to come from Medicaid. It is unclear where this would leave the hardliners who are also potential no votes.

If you are a student of politics, it does not get more interesting than the hard squeeze from competing forces being felt by these centrist Republican Members.

Post-script: Tuesday night, February 25, the House voted 217-215 to adopt the House budget resolution that starts the reconciliation process. According to this breaking story from Roll Call (here):

Conservative Republicans: They wanted to ensure that “cuts to discretionary spending are made as part of the likely upcoming stopgap appropriations bill needed by March 14.” Representative Warren Davidson of Ohio said that he had “received ‘assurances’ that cuts would be part of that deal and future spending bills.”

Centrist Republicans: “won reassurances from House leaders….that cost-cutting would focus on Medicaid fraud, while not touching benefits for those eligible for the program.”

Presumptively, the Conservatives will get the spending cuts (which are likely to hurt public health agency funding) and the Centrists will discover that Medicaid access and funding are just as important as benefits.

2. The Disconcerting Consequences of Lay-Offs By Fiat.

Several readers asked about the reported return of some laid-off CDRH employees and I pointed to the serious harm regardless of the number of employees recalled.

Probationary employees were the target of the lay-offs, presumably because they have less job protection. This includes employees in their first couple of years of government service, many recruited because of their expertise in innovative areas, such as AI. Employees promoted in a competitive recruitment within the last year or two are also considered probationary. These are competitively-determined winners, highly valuable to the agency and being punished for their ambition.

My response, repeated by several publications: “It is good that some are being called back, but that does not undo the harm of lay-offs done by fiat rather than performance reviews.”

3. User Fees and Lay-Offs at FDA

My February 23 column concluded that:

yes, FDA employees can be laid-off, regardless of funding source;
yes, the FDA lay-offs saves the government money; and
no, the lay-offs does not affect the user fee agreements, although it may affect whether certain milestones are reached on time.

The details and explanation are at: https://www.fdamatters.com/fdamatters/special-edition-fda-rifs-and-user-fees-explained.

Note: Since the original column was published, I have become aware that the lay-offs should not be referred to as a reduction-in-force because that term triggers certain procedures and protections that employees might not have in the case of lay-offs.

4. Pass the word: sign-up to receive FDA Matters.

Forward this e-mail to colleagues and friends and urge them to subscribe at www.fdamatters.com.

The stakes are fully described in my recent column, https://www.fdamatters.com/fdamatters/fda-and-budget-reconciliation-2025-a-primer. Future expenditures (one to two trillion dollars over the next decade) may shift from Medicaid, Supplemental Nutrition Assistance Program (SNAP), and other human services programs to defense, border security, and sustaining tax cuts from nearly a decade ago. In that context, discretionary programs, such as FDA, are certain to be hit harder than might otherwise be the case.
https://www.howdemocracyworksnow.com/glossary/whip-count
The margin is so tight that Represent Elise Stefanik, President Trump’s nominee for UN Ambassador cannot yet resign her congressional seat to take the position.
This is a reminder of the story of the senior citizen loudly decrying government-run medicine, while also arguing against any cuts in his Medicare benefits.

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