FDA Matters Blog

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.

Our complex and far-flung food supply is only safe because tens of thousands of people work vigilantly every day to make it so. A well-funded federal-state-local-global network lessens the risk, although even with adequate funds the risk never goes away.

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…

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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

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.”

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…

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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.

“FDA Matters: The Grossman FDA Report” provides short-form analysis and commentary on FDA policy and regulatory issues.

We intend to publish one or two columns a week. We respect your privacy, and our mailing list will never be used for any purpose other than dissemination of analysis and commentary relating to FDA.

STEVEN GROSSMAN 2/23/25 STEVEN GROSSMAN 2/23/25

SPECIAL EDITION: FDA, Lay-offs, and User Fees Explained

Information for Reporters

Last Saturday’s Reduction in Force (RIF) at FDA included some FDA employees whose salaries are “fully paid by user fees.” This surprised many and set off a lot of speculation as to how that saved the government money and whether it meant that FDA was unilaterally changing the terms of the user fee agreements.

Short Takes and Updates—February 20, 2025

1 FDA At Risk on Four Fronts
All the federal public health programs are under siege. While my focus is on FDA, I want readers to know that NIH and CDC face similar (but not identical) threats.

Reduction In Force (RIF). The new Administration sent lay-off notices to…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. FDA At Risk on Four Fronts

All the federal public health programs are under siege. While my focus is on FDA, I want readers to know that NIH and CDC face similar (but not identical) threats.

Reduction In Force (RIF). The new Administration sent lay-off notices to an unknown number of FDA staff over the holiday weekend. The common element is that they were on probationary status and thus have a lower level of job protection. I described and commented on this in my column earlier this week: If Being Mission Critical Is Not Important Enough, What Is?

The situation is still unclear as of midday on February 20. Over the last 24 hours, I have been responding to reporters with the following statement:

From watching OMB and FDA interpret these types of orders and directives in 2017, I learned there is a lack of clarity when they are first announced. Whether and how much FDA would be affected requires reading the fine print—in the overall declaration and then how it is to be applied to the massive responsibilities, different personnel systems, multiple funding sources, and wide range of skills needed at FDA.

In this case, we do not know the numerator (laid off by center/office) or the denominator (total laid off at FDA), so it is impossible to talk about either general or specific impacts. We need to let the dust settle.

For those of us who are watching, it is frustrating not to know. For FDA employees--those who are living it—it is probably closer to excruciating.

FY 2025 Appropriations/Possible Shutdown. FY 25 has been funded by Continuing Resolutions since October 1 of last year. The current CR expires on March 14 and so far, there is no deal on total spending or specific bills. According to Politico, “Republican appropriators sent a new offer to their Democratic counterparts over the weekend.”

FDA is at risk in two ways. If they reach an agreement, there is potential for FDA funding to be cut. If they do not reach an agreement, then there could be an additional CR or a shutdown.

Budget Reconciliation. Compared to the other two threats, this one is going to take longer and unwind a bit more slowly but could lead to substantially greater downward pressures on domestic discretionary programs. I did a deep dive on this last week: FDA and Budget-Reconciliation 2025: A Primer and supplemented it here. The process continues in both the House and Senate.

Impoundment of Appropriated Funds (new and a wildcard). President Trump and OMB Director Russ Voight have asserted the President’s authority to impound Congressionally-appropriated funds….notwithstanding Constitutional provisions that have always been interpreted to the contrary. It is possible that FDA funds could be impounded, and the agency drawn into this battle. (h/t to Alec Gaffney at Agency IQ. You can sign up for their daily newsletter, FDA Today, at https://www.agencyiq.com/subscribe-fda-today/).

2. FDA and the Upcoming Attempt to Gut Medicaid: Are There Any Overlapping Issues?

The status of Medicaid may seem to be in doubt[1], rather than pre-determined. However, under the pending House Budget Resolution, House Energy and Commerce committee will be expected to deliver $880 billion in savings over the next decade. There is no way to achieve that result without massive reductions in the Medicaid program. All options to do so are painful[2].

As reconciliation efforts advance in the House and Senate, the status of Medicaid is going to be grabbing headlines. On the one hand, the President’s agenda and tax cuts cannot be paid for without the Medicaid cuts. On the other hand, the traditional Republican position on the value of Medicaid is going to clash with the reality that Medicaid (including program expansions of the last dozen years) are popular in many red states.

My question to FDA Matters’s readers: do FDA and FDA stakeholders have a stake in the Medicaid battle? If so, what are the issues?

3. What I Am Listening To

Wayne Pines and Shelly Garg have launched FDA Watch (https://fdawatch.libsyn.com/), which offers podcasts about FDA. I recommend signing up.

This week’s guest is Janet Woodcock, discussing FDA’s future and the evolving regulatory landscape. You can also catch my appearance on January 20, along with Marc Scheineson of Alston & Bird, discussing the “The New-Look FDA in 2025.”

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.

Politico has reported this morning that: “Hours after pledging that the safety net program [Medicaid] “is not going to be touched,” Trump surprised some of his own staff Wednesday when he endorsed a House budget that would gut Medicaid.”
https://www.medpagetoday.com/publichealthpolicy/medicaid/114286?xid=nl_mpt_morningbreak2025-02-20&mh=29c54ab68180a56fae3d0da7029532a9&zdee=gAAAAABm4xE_8LqQ41dXUZAuGt2ybZFptmDDrkqWtRSJDN7TumcpCbqCgoGHLH3C0yUuUSbSeq0P-58l2HJlKPNjmbPnXTXnf_uS9sNSi6wLif3Sob3Ci7A%3D&utm_source=Sailthru&utm_medium=email&utm_campaign=MorningBreak-B_022025&utm_term=NL_Daily_MB_B

STEVEN GROSSMAN 2/18/25 STEVEN GROSSMAN 2/18/25

If Being Mission-Critical Is Not Important Enough, What Is?

FDA employees--public-spirited and committed—are the heart of the agency and can proudly point to a lengthy record of accomplishment. Our country has safe food and safe and effective medical products because of their efforts. We are all affected: every American uses FDA-regulated goods and services at least several times each day…. read more…

FDA employees—public-spirited and committed—are the heart of the agency and can proudly point to a lengthy record of accomplishment. Our country has safe food and safe and effective medical products because of their efforts. We are all affected: every American uses FDA-regulated goods and services at least several times each day.

It is said that FDA’s best days are quiet ones—everything runs smoothly, nothing of public concern happens. Given the vastness of the agency’s responsibilities that is an incredibly high standard.

Although the numbers are still uncounted, the agency suffered a brutal and seemingly arbitrary purge of probationary employees over the holiday weekend. Not only were relatively new employees swept away, but also many employees who received competitive promotions in the last two years (a process by which many of them might be considered “the best of the best.”). As extensive as the Reduction in Force (RIF) seems to have been, there are likely to be more attempts to lay off FDA employees.

It is wholly appropriate for the FDA community to deeply mourn its institutional and individual losses.

Employees on probation were an arbitrary target—chosen solely because they are an easier target than employees with more job protections. As far as I can tell, there was no triage based on protecting priority FDA functions and services or assuring needed skills.

For many years past–and presumably for many years to come—a key goal of advocates has been to impress upon Congress, the Executive Branch, and the public that FDA is an extraordinarily valuable agency providing a core function of government. The explicit message: the agency needs more money so it can better fulfill its growing mission. The implicit message: if cuts need to be made in government spending, FDA’s funding should be among the last to be considered.

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. But that’s no crazier than cutting FAA staff who assure safe air travel after three incidents in the last few weeks (here), or probationary FBI agents (here), or cutting (since rescinded) the jobs of personnel who maintain nuclear safety and security (here). USDA work that relates to Avian Flu also experienced frontline cutbacks (here) that are inexplicable.

If any of these agencies were told: next year you will have to function with fewer employees….it would be awful, but foreknowledge and flexibility would certainly help the agency lessen the damage by prioritizing mission-critical activities.

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?

INFORMATION FOR FDA EMPLOYEES from the FDA Alumni Association:

New resource page tailored to the needs of FDAers: Today the FDAAlumniAssociation posted a reference page outlining information sources that FDA staff might find helpful during this time of transition. The reference page is a work in progress, so if there are additional links you believe would be helpful that we should consider adding, please contact FDAAA. A huge shout out to the EPAAlumniAssociation that permitted us to poach some of their information sources. If you are planning to leave the agency or choosing to stay and would enjoy seeing familiar faces, please consider joining FDAAA. We appreciate you! https://lnkd.in/eR3bsQSA

According to one article I read, the White House has claimed that the government-wide RIF followed priorities and chose people whose jobs were less important. The article continued with a quote from a third party to the effect: if that is the case, then the people making the decisions had no understanding of the jobs people were performing.

STEVEN GROSSMAN 2/14/25 STEVEN GROSSMAN 2/14/25

Short Takes and Updates—February 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…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. 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.

2. More on FDA and Reconciliation.

My primer on FDA and reconciliation (here) was widely read and should have an extended shelf life. The point of my primer is that the deep budget cuts from reconciliation (adopted by authorizing committees) will create an appropriations funding environment that puts FDA (and NIH, etc.) at risk.

The tie between reconciliation and appropriations was reinforced at yesterday’s House Budget Committee mark-up, where cost-cutting targets were increased to accommodate the House Freedom Caucus (here). HFC members are eager for deep cuts in appropriated funding.

A couple of readers asked: is FDA also vulnerable to cuts in funding through the reconciliation process itself? Under the House reconciliation bill adopted in the Budget Committee yesterday, House Energy and Commerce Committee was directed to generate a minimum of $880 billion over ten years. At that scale, the primary target will be Medicaid.

To achieve savings from FDA, House E&C would have to adopt statutory language that had a budget impact on the agency. This seems unlikely but not out of the question.

3. What We Are Reading: Reversing Misinformation by Michael Miller, MD.

Inspired by Teddy Roosevelt’s comment that “complaining about a problem without offering a solution is called whining,” health policy analyst, Michael Miller decided that confronting rampant medical misinformation deserved a practical guide for individual action.

More about the book and about “Dr. Mike” can be found here.

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.

“FDA Matters: The Grossman FDA Report” provides short-form analysis and commentary on FDA policy and regulatory issues.

We intend to publish one or two columns a week. We respect your privacy, and our mailing list will never be used for any purpose other than dissemination of analysis and commentary relating to FDA.

STEVEN GROSSMAN 2/12/25 STEVEN GROSSMAN 2/12/25

FDA and Budget Reconciliation 2025: A Primer

Part 1: Meaningful Deficit Reduction Requires More Than Cuts to Discretionary Spending

In FY 2024, the federal government spent $6.75 trillion and collected $4.92 trillion in revenue, resulting in a deficit. The amount…

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

“A cynic knows the price of everything and the value of nothing.”—Oscar Wilde

Part 1: Meaningful Deficit Reduction Requires More Than Cuts to Discretionary Spending

In FY 2024, the federal government spent $6.75 trillion and collected $4.92 trillion in revenue, resulting in a deficit. The amount by which spending exceeds revenue, $1.83 trillion in 2024, is referred to as deficit spending[1].

There is near-universal agreement that the annual federal budget deficit must be reduced. If allowed to continue, it would add $18 trillion to the national debt over the next ten years.

“The iron triangle of deficit reduction” refers to the three ways (and only three ways) in which annual government deficits can be reduced or eliminated[2]:

discretionary spending cuts (defense and/or non-defense);
reduction in entitlement payments and other mandatory program spending; and
increases in federal revenue through economic growth or additional taxes.

All discretionary spending taken together ($1.7 trillion in FY 24) is less than the annual deficit.

Nonetheless, every year, Congress attempts to achieve meaningful deficit reduction through the appropriations process, while also supporting increases in funding for defense, homeland security, and veterans. This puts overwhelming downward pressure on all other discretionary programs, including FDA.

Meaningful deficit reduction can only be achieved by substantially increasing federal revenue and/or significantly reducing the costs of entitlements and mandatory programs.

Addressing revenue and mandatory programs can be done by stand-along bills. However, as a practical matter, major changes in revenue and/or mandatory programs are unlikely except through budget reconciliation.

Part 2: Budget Reconciliation Explained

As envisioned by the Budget and Impoundment Control Act of 1974, Congress has an obligation to develop and pass a budget resolution that determines spending, revenues, deficit or surplus, and the public debt for a fiscal year.

The appropriations committee then takes over and allocates the discretionary programs monies by subcommittee and program so as not to exceed the amount provided in the budget resolution. Most years, Congress does not pass a budget resolution and, instead, total discretionary funding is set as part of a bi-cameral leadership package that includes appropriations bills[3].

In the years that Congress has passed a budget resolution, it is usually for the purpose of creating “reconciliation instructions” that direct authorizing committee to find specific amounts of savings and/or find offsets for increases in the programs they oversee. Reconciliation directions do not go to the appropriations committees because they are already constrained by spending ceilings.

Since 2000, seven out of the eight budget resolutions/reconciliation instructions are associated with a period when the same party controlled the House, the Senate, and the Presidency and six of them increased projected deficits[4]. This reflects the procedural advantages: the budget reconciliation only requires a majority vote in the Senate and cannot be filibustered. That makes it a more desirable way to move major legislative initiatives than the ordinary legislative route.

There are two notable limitations: reconciliation can only be used to make changes that have budgetary impact; and the reconciliation process can only be used twice in every fiscal cycle.

Part 3: Complex Reconciliation Goals/Politics in 2025

Republicans in Congress are trying to achieve three primary goals in budget reconciliation in 2025:

Increase resources available to support President Trump’s agenda, notably increased funding for efforts to secure the border, bolster our military, and increase American energy independence ($342 billion over four years according to a proposal under consideration in the Senate Budget Committee. Mark-up starts on February 12, 2025).
Reduce the annual federal budget deficit from its current unsustainable levels (a 25% reduction in the annual deficit would require $4.5 trillion over 10 years; halving the annual deficit would require about $9 trillion over 10 years).
Find savings and revenue enhancers to pay for the cost ($4.7 trillion over 10 years) of extending the individual tax cuts enacted in President Trump’s first year (2017) and expiring on December 31, 2025.

In the Senate, Budget Chair Graham is trying to do program changes (bullet one) in a bill now…and deficit reduction (bullet two) and taxes (bullet three) in a bill later in the year. Speaker Johnson is trying to achieve agreement in the House for one bill to do all of this—to be moved this Spring.

The politics of this….and how it will play out…are beyond the scope of a blog focused on FDA issues and policies. However, achieving these three goals will probably require $1 trillion per year in additional revenue (tariffs?), mandatory program cuts[5], and savings from continued powerful downward pressure on domestic discretionary spending.

This is a cynical process (h/t to Oscar Wilde) in which many programs will be cut or eliminated because of their cost (price), regardless of their value.

In such an environment, FDA’s fate is not sealed, but its prospects for sustaining and increasing its budget are not promising.

The arguments for the value of FDA to public health, safety, and commerce will need to be voiced loudly by the entire FDA stakeholder community. They will need to do so repeatedly, until the value produced by FDA is seen as so great that paying the agency’s cost (price) becomes seen as a necessity….even in a dramatically smaller federal budget.

https://fiscaldata.treasury.gov/americas-finance-guide/national-deficit/
The fourth major category of budget expenses is interest payments on the national debt. These are set by market forces and cannot be reduced by law or fiat without jeopardizing the government’s ability to finance the totality of the US debt, which exceeds $36 trillion. The public holds nearly $30 trillion of that debt.
There are no consequences if Congress fails to adopt a budget resolution.
https://www.cbpp.org/research/introduction-to-budget-reconciliation
Social Security and Medicare are likely to be spared for political reasons, meaning even deeper cuts in Medicaid, SNAP, and other means-tested human services programs.
According to the 2-12-25 issue of POLITICO Inside Congress, some House Freedom Caucus members are pushing for a $2 trillion target.

STEVEN GROSSMAN 2/6/25 STEVEN GROSSMAN 2/6/25

Short Takes and Updates — February 6, 2025

Today is the first “Short Takes and Updates” column. For those who have not signed up to receive the FDA Matters newsletter in your email box, go to the home page to register.

1. US to Leave the World Health Organization—An Alternative Interpretation.

For those who followed Trump 1.0 closely and parsed Project 2025 carefully, it is not a surprise that the World Health Organization (WHO) has been targeted by the new Administration. A summary of items in dispute is here.

However, I did not expect the notice of withdrawal to be a “day one” priority nor did I expect it would be in the form of an executive order (here). Fortunately, there is some leeway–best understood as: our participation ends now, but the required notice of one year means we are, at least for now, still members.

At last week’s wide-ranging Kinexum-sponsored webinar (https://youtu.be/9GMdrZ6fdY4 and https://youtu.be/eK9dUwcLNiY), a deep bench of participants with FDA expertise, spoke eloquently about the value and continuing need for WHO. Clearly, exiting WHO would be a loss for both US and global health.

In response, I offered an alternative interpretation of what might happen next. The new Administration likes to open with an extreme position (e.g., tariffs will be imposed in three days) then use that to gain leverage in subsequent negotiations. I am hopeful—albeit far from certain—that WHO will work out that way. It may require changes at WHO—perhaps significant one—but the US will continue to belong. At least that is my hope.

2. The Time Is Ripe for Improving Food Safety.

My earlier column (Down is Good and Up Is Bad ; Or is the Other Way Around?) concluded that: “There is no better time than now to create a comprehensive plan for improving food safety at the federal, state, and local levels — and push forward together as a community for its funding and implementation.”

As reported by Food Safety News (here), the General Accounting Office has issued a new report on food safety (here), which concludes that: “We previously reported on the need for a national strategy to guide federal efforts to address ongoing fragmentation and improve the federal food safety oversight system. This strategy could address our other previous matters for congressional consideration about a government-wide performance plan and sustained leadership for federal food safety. We maintain that such a strategy could create an opportunity to further strengthen federal oversight of the nation’s food supply and reduce the economic and public health effects of foodborne illness.”

To my many friends in the food stakeholder community, as well as the leaders of FDA, CDC, and FSIS: the time is now, let’s work together to make this happen!

Another voice in agreement: Frank Yiannas, former Deputy Commissioner for Food Policy and Response at FDA weighed in this morning with a column in Food Safety News (here).

3. Retirement-eligible FDA Employees Likely Key to How Many FDA Employees Accept the Proposed Buy-Out

My inaugural column on January 10, (Is a Mass Exodus From FDA Coming Soon?), urged FDA employees not to resign prematurely. Despite the subsequent “fork in the road” buy-out offer from OPM, that still seems to be the predominate advice. See analysis and recommendations: here, here, here, and here.

When numbers come out, probably soon, it is important to remember that there are many different jobs, situations, and career goals among FDA employees. As I wrote in the original column, one segment, those who are “retirement-eligible,” may “have a different calculus than those with shorter tenures in the federal government. In many cases, they do not face a significant loss of income if they leave the agency. Presumably, they also skew older and may have less interest in waiting to see how things turn out.”

“An unknown is how much of the FDA workforce is retirement-eligible. Last Fall, an FDA official told me ‘15%.’ However, it was a casual conversation, and I do not know whether his answer was actual or speculative. At the 15% level, with perhaps 25% uptake, the impact of resignations by retirement-eligible individuals would be significant, but perhaps not overwhelming.”

As a point of reference: 15% of 18,000 employees is 2700. If the uptake is 25%, as I have speculated, that would be about seven hundred retirement-eligible employees taking buy-outs. The actual percentage might be higher or lower for this group of individuals. Of course, this does not predict any particular outcome for the remaining 85% of FDA employees.

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