Q&A - September 29, 2025

This week’s questions:

• State public health officials are having to make difficult decisions about whether to follow CDC guidance on vaccines and other topics. Could there be a similar erosion of trust by states regarding FDA guidance?

• Anti-vaccine policies poll poorly and Republicans are worried that Secretary Kennedy’s approach could hurt them in the 2026 election. What do you think?

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Q: State public health officials are having to make difficult decisions about whether to follow CDC guidance on vaccines and other topics. Could there be a similar erosion of trust by states regarding FDA guidance? 

A: Possibly. Not yet. Hopefully never.

It also depends upon which function of FDA is being addressed. Here is a way to look at it:

The federal government and states run parallel integrated public health programs (CDC public health guidance and surveillance, FDA food safety programs, and FEMA for disaster relief). To some extent, every state has a mini-CDC agency — generally less well-funded and less well-staffed. But most are quite capable.

Devolving responsibilities to the states — either by intention or by creating a vacuum at the federal level — would be inefficient and, in the aggregate, quite costly. Most states and regional compacts have access to sufficient information and expertise to develop reasonably sound policy and guidance. However, decisionmaking would likely not be as good or as authoritative without national expertise, networks, and information collection. Uniformity is a critical benefit.

Of course, devolution makes no sense in other ways. Each of the fifty states crunching surveillance data or employing multiple experts in Listeria is inefficient and expensive. Importantly, state borders don’t constrain the pathogens that cause communicable diseases and unsafe food. [note: this same logic would apply to FEMA, which is also under attack].

Vaccine production is a separate and specific case. The federal government taking the lead is essential for supply purposes, equity among the states, and the funding of innovation.

At least as far back as Operation Warp Speed, there has been tension between the CDC role (public health guidance on vaccine schedules) and the FDA role (labeling for use of approved vaccine products).

Adding fifty states with an unlimited number of variations seems confusing, unwise, and a serious impediment for manufacturers. Were this to occur, it would be detrimental to public health, disease prevention, and the development of new vaccines. Large-market states would receive significantly more attention than small states, creating a serious equity problem.

States can more readily take up the CDC guidance role than the FDA product labeling role. Neither is desirable.

The FDA’s approval of medical products has no obvious parallel at the state level. No other organization has the capacity, expertise, or authority to approve medical products that will be involved in interstate commerce, which is effectively “everything.” However, this is not without its challenges. For example, Montana is trying to create a haven for doctors to treat patients with unapproved and experimental drugs (https://bit.ly/45TrXS8; https://bit.ly/4m8HWl2).

In summary, the first scenario (states deciding public health policy in the absence of CDC) is unwise. The second (states disrupting the national market for vaccines) is truly awful. The third (states trying to bypass the Food Drug and Cosmetics Act and making decisions on the use of medical products) is a disaster.

Q: I heard that anti-vaccine policies poll poorly and Republicans are worried that Secretary Kennedy’s approach could hurt them in the 2026 election. What do you think?

A:  I am not surprised that current vaccine policies poll poorly. Assuming that’s the case, then the Republican National Committee (RNC) is likely to be concerned.

However, I don’t see that mattering much, if at all. “Hot-button” issues thirteen months before an election are a poor predictor of what will motivate voters to show up and vote a particular way on election day.

Furthermore, I don’t see public opinion translating into enough angst for Republican Senators and Representatives to risk offending the President by calling for the ouster (or restraint) of a cabinet member, especially one who is perceived by the White House as having contributed to Trump’s 2024 electoral success.

Regarding the durability of Robert F. Kennedy, Jr. as Secretary of HHS, I last addressed this three weeks ago in a prior Q&A on Monday (here). My focus then was that Kennedy’s appearance before the Senate Finance Committee on September 4 was great “political theatre” and probably viewed quite favorably by President Trump.

My updated view: Secretary Kennedy’s stock at the White House is undiminished and anti-vaccine policies will continue unabated.

The argument that Kennedy threatens President Trump’s legacy by undercutting Warp Speed... rests on the assumption that either Trump or Kennedy is troubled by the inconsistency. I see no evidence that it does. At the September 4th hearing, one of the questions was whether Warp Speed was a crowning achievement of Trump’s first term. Kennedy agreed it was, but then went right back to bad-mouthing the safety, efficacy, and need for COVID vaccines.

Kennedy’s temperament is probably more like Trump's than that of any of Trump's other cabinet members or close advisors. I sense that Trump is delighted by Kennedy’s shenanigans and sees himself benefiting from Kennedy’s energetic, iconoclastic, pugnacious, and norm-breaking approach. He probably wishes he had more Kennedy’s in his cabinet.

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[1] Weekend announcements receive less attention, especially in this case, being sandwiched between the ACIP vaccine meeting and the Charlie Kirk funeral. Kudos to the Washington Post for covering it. CORRECTION: I have been told that the WSJ first broke the story, not WP. I am glad both publications saw the announcement as newsworthy.

Q&A - September 22, 2025

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This week’s questions:

• Is there something that received less attention but particularly concerns you? (Yes, termination of the Household Food Security survey)

• Will there be a government shutdown? What are the likely impacts for FDA if there is one?

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Q: It has been an overwhelming September for FDA. Is there something that received less attention but particularly concerns you?

A:  Yes. On Saturday, USDA  announced that it was terminating its Household Food Security survey on hunger in America (Washington Post article). The decision to announce this over a weekend only reinforces the bad intent: if we don’t measure food insecurity, then we can claim that it doesn’t exist.[1]

Food insecurity is one of the most pressing health problems in the United States. As a concern, it is roughly on par with 1/ misguided unscientific vaccine policies, and 2/ a war on chronic diseases that has no policy on tobacco reduction.

People sometimes say “a good life” starts with good health...I believe it starts with enough food. Hunger causes health problems, plus it saps the ability of children to do well in school and the ability of their parents to participate in the job market.

If we want America to be healthy, then food insecurity should be a high priority. I don’t have a problem with MAHA’s interest in the safety of food ingredients; I just don’t understand why food insecurity isn’t also at the top of their list.

It is an inconvenient truth, but nonetheless true, that: “hungry people buy whatever sustenance they can afford from whoever can supply it. Quality, safety, and nutritional value become, at best, secondary considerations.” (from my column A Message to MAHA: Every American Should Have Access to a Healthy and Affordable Diet).

In support of my point: in early September, McDonald’s expanded its value menu. In response, many restaurant chains expanded their budget options (Fox Business News).  The CEO of McDonald’s was quoted as saying: “Particularly with lower and middle-income consumers, they’re feeling under a lot of pressure right now.” He added: “What we see is it’s really a two-tier economy right now.” CNBC.

So, yes, terminating the Household Food Security report is a BFD. The 2023 report showed that 47.4 million Americans lived in food-insecure households. (Food Security in the U.S. - Key Statistics & Graphics | Economic Research Service).

By not measuring food insecurity, the administration can pretend hunger in America doesn’t exist. Sadly, the problem will not be resolved by ignoring it.

Q: Will there be a government shutdown? What are the likely impacts for FDA if there is one?

A: The battle over FY 26 funding brings to mind Otto von Bismarck’s aphorism that “Laws are like sausages; it is better not to see them being made.”

Funding for FY 25 ends at midnight on September 30. Without new legislation (either funding bills or a Continuing Resolution), the government will shut down the morning of October 1. Why is passage of a CR not simple and straightforward?

First, each party has a different version of what needs to be contained in a CR. Second, the House and Senate are both in recess this week, with the House scheduled to return on October 6 and the Senate on September 29. Before leaving town, the House passed two CR’s, but (as expected) the Senate did not approve either bill.

So, there are three possibilities: the Senate reconsiders the House bills; the House returns to DC for negotiations and votes; or the government will shut down. The consensus among various pundits is that the likelihood of a shutdown is about 50/50, which is to say, nobody has a clue how this will play out over the next 10 days. The President has just agreed to meet with Democratic leaders on Thursday. After that meeting, the odds regarding a shutdown will be re-assessed. [Update: Trump just cancelled the meeting. CBS News]

FDA notes:

• There is an exceedingly small, but non-zero, chance that the Ag/FDA funding bill for FY 26 passes before October 1. In that case, FDA, in its entirety, could operate without interruption at whatever level is appropriated in the funding bill. That is likely to be a bit less than the FY 25 funding level.

• If there is a CR, it is likely to extend through October 31 (Democrats) or November 21 (Republicans). Funding will be at FY 25 levels, and the agency will be limited in its ability to start new initiatives.

• If there is a shutdown, FDA will operate under this plan (here) or an updated FY 26 version that HHS would probably release at the end of this week or, at the latest, on Monday. While FDA’s situation is more favorable than most other agencies (75% of the FDA workforce will be able to continue to work), it will not, by any means, be “business as usual.”

There are a lot more nuances in shutdown workloads, which I will address if 1/ the likelihood of a shutdown grows, or 2/ HHS’s updated shutdown plan is announced.

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[1] Weekend announcements receive less attention, especially in this case, being sandwiched between the ACIP vaccine meeting and the Charlie Kirk funeral. Kudos to the Washington Post for covering it. CORRECTION: I have been told that the WSJ first broke the story, not WP. I am glad both publications saw the announcement as newsworthy.

Q&A - September 8, 2025

This week’s questions:

• Is Secretary Kennedy at risk of losing his job?

• What is Kenvue? Doesn’t J&J make Tylenol?

• How realistic is it to dramatically shorten product review cycles?

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Q:  Is Secretary Kennedy at risk of losing his job?

A: Many people were wondering this past week about Secretary Kennedy’s job tenure....what with stories about the MAGA/MAHA split and his rambunctious appearance before the Senate Finance Committee, where he drew negative feedback from three Republican Senators.

The hearing was political theatre (a great show IMO), and everybody played their roles well  (here and here).  Kennedy was self-assured and unyielding. Actual shouting matches in Senate hearings are rare, but there were several between Kennedy and Democratic Senators. He accused one of them of being “a liar.”

Despite the President’s claim not to have seen a tape of the hearing, I have to believe that someone at the White House created a highlight reel for the President, and that he was delighted with Secretary Kennedy’s performance. All by itself, that would suggest Kennedy has some job security, at least to the extent that any official in the Trump Administration can count upon having a firm grasp on their job.

Three Republican Senators were critical of Secretary Kennedy, perhaps suggesting to some that broader Senate opposition to Kennedy might be coming. At least for right now, I don’t see that happening. The bulk of Senate Republicans will still be looking to President Trump for guidance on vaccine policy, not to their state health departments.

The approach taken by the Republican Senators was an interesting one, mirroring an argument that Michael Bloomberg laid out in an op-ed last week (here) and which is based on a Trump remark.  The goal was to get the Secretary on record saying that Operation Warp Speed (which stimulated the creation of the COVID vaccine) was a towering achievement of President Trump’s first term, worthy of a Nobel Prize. Kennedy agreed, but then went right back to bad-mouthing the safety, efficacy, and need for COVID vaccines.

As to the consequences of the hearing...you can’t judge the room by what was being said. It was political theatre. What matters is what Senators say to each other about Secretary Kennedy when the cameras aren’t rolling and no one else can hear. That still has to play out.

More than a guess but less than a prediction: Secretary Kennedy retains his position for now and continues his negative attitude about vaccines. The White House may force him to soften the attacks on COVID-19 vaccines, but probably not overrule him on the narrowing of the labeling.

Q: What is Kenvue? Doesn’t J&J make Tylenol?

A: Kenvue was created in 2023 by J&J spinning off its former Consumer Health Products division into a new company. It is the maker of dozens of consumer product brands, including Band-Aid, Neutrogena, Listerine, Aveeno, and Benadryl. More details are here.

Q: How realistic is it to dramatically shorten product review cycles?

A: FDA stakeholders and the agency--working together--have opportunities to shorten review times. It is, however, a complex situation, including concerns about budget and manpower needs. Numerous other trade-offs need to be discussed and resolved before comprehensive reform becomes possible. I plan to come back to this topic in the near future and devote at least one full column to it.

In the meantime, a good starting place is an explanation of the difference between real- and perceived-time savings. In their own ways, both can contribute to shorter reviews.

“Real-time improvements” would involve finding ways to increase productivity. If, for example,  AI can accurately and reliably summarize a 500-page protocol in a day that would otherwise take a week, that provides a net gain in productivity and allows for the possibility that four days could be subtracted from review times.

AI aside, productivity gains might come from consolidating forms, eliminating duplicative steps in the review process, and changes in review flow or staffing. It is worth exploring Dr. Makary’s idea of compressing the final decision (not all of the work) into a noticeably shorter timeframe through an in-person meeting.

“Perceived-time improvements” would come from finding ways to move more of the agency’s and sponsor’s efforts so that they are carried out before Day 0 (when the NDA or BLA is submitted). Rolling review--where companies submit chapters of the application to FDA for review before submission--displaces some amount of time that the agency would otherwise have to expend during the 6–9-month review process.

In most instances, rolling review should generate perceived-time improvements relative to the submission date. It may also affect agency productivity, but I do not have the data to show whether rolling review takes more or less time and manpower than conducting the entire review after submission.

As noted, I will be writing more about “shorter review times” in the near future.

Q&A - September 1, 2025

This week’s questions:

• What’s at stake when a CDC director won’t sign off on the Administration’s vaccine policies, is fired, and several senior center leaders resign?

• What happens next at CDC?

• What are the possible impacts of the CDC situation on FDA and NIH?

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Q: What’s at stake when a CDC director won’t sign off on the Administration’s vaccine policies, is fired, and several senior center leaders resign?

A:  I try to avoid hyperbole and am sensitive to recency bias....so I won’t say the CDC situation is the worst I have seen in my many years in DC. It is undoubtedly near the top.

The President Leads the Executive Branch. The only elected members of the executive branch are the President and Vice President. Subject to Congress (enacting laws or exercising the power of the purse) or the Supreme Court (ruling on lawsuits involving decisions made by the Executive Branch), they are free to interpret their election mandate however they wish. That includes ordering “subordinate officials” to carry out Administration policy.

Subordinate Officials Take an Oath of Office. However, those subordinate officials took an oath of office to uphold and defend the Constitution and to “well and faithfully discharge the duties of the office upon which I am about to enter.” Independent of the substance of the matter, Dr. Susan Monarez, CDC Director, was being asked to announce a national policy on behalf of the CDC that had not, in fact, been approved or even vetted by the CDC. Presumably, she felt that doing so would force her to violate her oath of office. So, she refused to sign off on the proposed vaccine policies.

Priorities beyond the Oath of Office An extreme but not outlandish interpretation of “policies narrowing vaccine availability and accessibility” is that they could lead to mass civilian casualties (mortality and morbidity). The short-term risk is more likely to be measles than COVID, but the long-term risk of a new pandemic to an unprepared society has been widely discussed.

Viewed in this light, the Director of the CDC may have additional moral and legal imperatives — beyond their oath of office — to reject vaccine policies that leave a large portion of the population vulnerable. If mass casualties were to occur, “I was just following orders” would not be a sufficient defense.

Q: What happens next at CDC?

A: In the interim, Jim O’Neill, HHS Deputy Secretary, will also serve as Acting Director of CDC. Under the Vacancy Reform Act of 1998, he can serve in this capacity for up to 210 days (until mid-to-late March 2026). He was a political appointee at HHS in the second Bush and Trump 1.0 administrations, so CDC is familiar to him. Reportedly, he is pro-vaccine but also, reportedly, he has a good working relationship with Kennedy. Like several HHS leaders, he was harshly critical of the Biden administration's handling of COVID.

Q: What are the possible impacts of the CDC situation on FDA and NIH?

A:  Nothing necessarily changes for Dr. Makary and Dr. Bhattacharya (NIH). They already knew--and needed no reminder--that they are employed “at will” and can be fired without cause and at any time by the HHS Secretary and the President[1].

That’s inherent in their jobs and was true for their predecessors, as well.

Hopefully, they now have months of experience in managing their relationship with Secretary Kennedy and have gained his trust. In that time, there are undoubtedly positions they have taken that were ordered by the Secretary...and others in which they anticipated his views and incorporated them on their own initiative. (note: before anybody thinks ill of this--almost all jobs, public and private, require managing your boss and anticipating his/her responses to your own planned decisions and actions).

The future we are experiencing now was foreseeable. Two months ago, mindful of the delicate political balance that all agency heads must navigate, I wrote “Commissioner Makary is operating in a political environment that is arguably more challenging than any FDA commissioner has faced since the agency’s creation in 1906.”

The column, “All of Us Need to Be Rooting for FDA” (https://www.fdamatters.com/fdamatters/all-of-us-need-to-be-rooting-for-fda) raised some eyebrows and resulted in it being widely reprinted. 

My analysis and point-of-view have not changed: a stable and functional FDA, regardless of its flaws, will be better for the American public and stakeholders than a chaotic and dysfunctional agency. The same can be said of NIH.

[1] If so inclined, nothing prevents Secretary Kennedy from treating FDA and NIH the same way he has just treated CDC. Notably,  many HHS statutes affecting HHS’s jurisdiction direct the Secretary (not subordinate officials) to take implementation actions. Agency heads can act because authority is delegated to them by the Secretary. Little prevents the Secretary from withdrawing the delegations of authority and making most or all of the decisions now made by the heads of CDC, FDA, and NIH. For everything else, he can appoint an acting head as he has with CDC.

Q&A - August 25, 2025

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This week’s questions:

• Did your column on MAHA intend to deliver a specific message to journalists and lead advocacy groups?

• What is the most critical FDA issue in September?

• What are some FDA issues that are simmering and will eventually surface?

• Do you have suggestions for how I (and others like me) can take meaningful action or contribute to defending FDA, NIH, and CDC?

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Q: Did your column on MAHA (A Message to MAHA: Every American Should Have Access to a Healthy and Affordable Diet) intend to deliver a specific message to media and lead advocacy organizations?

A: MAHA is a slowly unfolding train wreck. Which is a shame because the MAHA movement raises questions about the American food supply and healthy diets that are worth the time and trouble to resolve. Americans deserve better dietary guidance and a more substantial investment in food safety than they currently receive. At this time, it is unclear how we will derive anything of significant value from the process being set in motion as a response to the MAHA movement

The temptation for the media, as well as the public, is to get drawn into the dramatic clash of absolutes. That is the antithesis of the dialogue and compromise necessary to produce profound and lasting changes in healthy diets. It is crucial to keep in mind that healthy diets are far more complicated than limiting or eliminating dyes, pesticides, and preservatives. Nutrition education and access to wholesome, affordable foods are cornerstones to a healthy diet, as well as many other variables discussed in my column.

IMO, the media and lead advocacy organizations have an obligation to reinforce a more balanced view of the situation. This means continuing to emphasize the primary goal: providing better dietary options that Americans can afford, access, and integrate into their lives. Among other things, this forces nuance into discussions where only absolutes would otherwise be considered and reported upon.

Q: What is the most critical FDA issue in September?

A: FDA funding for FY26 will definitely be in play in September. There is the agency-specific aspect — the potential for FDA funding to advance through a minibus bill and actually become law before the end of the fiscal year. That would lock funding somewhat below the FY 25 level but would take the agency outside further budget fights (which are likely to get uglier) and it would allow the FDA to be unaffected by the threat and drama of a potential government shutdown on October 1.

Another aspect of FDA funding is the reauthorization of the OTC Monograph User Fee program, which must be completed by the end of September. This is important in its own right but is also an early signal of continued Congressional support for the other major user fee programs that expire on September 30, 2027.

Q: What are some FDA issues that are simmering and will eventually surface?

A: Here are a couple of issues that I have not written about recently, but which are sure to make headlines and draw concerns in the near future: 

FDA Headcount Relative to Its Responsibilities. ProPublica published an analysis last week (here), entitled “How Deeply Trump Has Cut Federal Health Agencies.” I cannot vouch for their analysis or intriguing methodology. However, it serves as a reminder that adequate agency staffing is essential for meeting FDA’s responsibilities.

If, as one might expect, FDA staff are triaging the most pressing items, then it is probably too soon to judge how the smaller workforce can fulfill all the agency’s responsibilities that keep food safe and our medical products safe and effective. My mid-April column, “Rx for FDA: An Agenda for the Commissioner,” discusses the challenge of restarting the agency's “engine of production” after layoffs and disruptions. It’s a notable reminder of where we were just four months ago.

 Alternatives to animal research and testing. Over the past 40 years, government, academic researchers, and industry have collaborated to reduce the use of animals in research and testing. It has been hard work, and improvements have been incremental rather than dramatic.

The Administration’s emphasis on increased development and greater acceptance of alternatives is laudable. However, they have overstated how close we are to eliminating animal research and testing. If FDA is not cautious, at some point in the future, there may be deaths or serious morbidities in a phase 1 trial, and there will be a reckoning on why risky preliminary research was not performed on animals first.

Q: As a former FDAer, I’m deeply concerned about the direction in which RFK Jr. is taking the FDA, NIH, and CDC. Do you have suggestions for how I (and others like me) can take meaningful action or contribute to defending these institutions?

A: My own approach is to continue what I have done for several decades: perform policy analyses of issues facing FDA and advocate for positions that help the agency fulfill its responsibilities. I hold the current administration to the same standards that I have applied to its predecessors in the past.

This approach suits my experience and skills but is not generalizable--and would not satisfy your own need to speak out.

Accordingly, I am opening this up to my readers. Are there organizations or other venues for this subscriber to reach out to?

Q&A - August 18, 2025

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This week’s questions:

• Why has CDRH seemed uniquely untouched by this year’s upheaval at the FDA?

• How does the WSJ editorial on drug approvals (here) relate to your late July article (here) calling for a National Agenda for Advancing Therapies for Chronic Progressive Diseases?

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Q: Michelle Tarver at the Center for Devices and Radiological Health (CDRH) has been uniquely untouched by this year’s upheaval at the FDA. She is, of course, particularly skilled at her job, but so were many other people who are no longer at FDA. What other factors might have helped to protect her?

A: For purposes of answering the question, I am going to assume that “CDRH has been more stable than the other centers” is correct. It certainly appears to be true.

The subscriber who submitted the question offered one theory: devices just aren’t as politically high-profile as most other regulated medical products, which has made it easier for CDRH and its director to fly under the radar.

I agree, but the relative lack of visibility has little to do with politics...and nearly everything to do with the nature of the drug and device industries and how their products are developed and regulated. Generally, medical devices are more numerous, face more product-to-product competition, are parts of broad product portfolios, and are created and incrementally improved within comparatively short innovation cycles.

Medical devices rarely fit into the pharmaceutical paradigm — a billion dollars invested over a decade or more, with each product eventually ending in an “all-or-nothing” decision by FDA and “all-or-nothing” revenue for the company. While patients need both drugs and devices, any given medical device approval is far less consequential than most drug approvals. This is reflected in the numbers — CDRH handled 24,400 device submissions in 2024, more than all the drugs and biologics on the market (here).

The timing of Dr. Tarver’s appointment to lead CDRH may have also helped. While she has had a long career at FDA, she was only made the permanent leader of CDRH in October 2024. She was not part of Commissioner Califf’s leadership team in the same way as Jim Jones (Human Foods), Dr. Cavazzoni (CDER), and Dr. Marks (CBER).

I was in a similar situation many years ago, and the incoming leadership decided that I had no loyalty to the old regime and could be reliably treated as one of their own. That may or may not have been a factor in the decision (thus far) not to replace Dr. Tarver.

Q: The Wall Street Journal Editorial Board published a column (here) that was critical of the FDA’s approach to approval of therapies for deadly and rare diseases. How does the WSJ position relate to your late July article (here) calling for a National Agenda for Advancing Therapies for Chronic Progressive Diseases?

A: We are both pulling in the same direction--as a response to recent decisions that seemed inconsistent with past policies and heedless of the plight of the many rare disease patients who face severe disability and death.

However, the WSJ argues from specific examples (drugs from Replimune and Stealth), thus mirroring the case-by-case approach that has dominated orphan drug thinking at the agency. A notable (and unfortunate) feature of this approach is that sponsors (companies), patients, and the FDA are often forced to engage in repeated disputes over clinical development issues on which the FDA should already have established policies and guidance to inform its case-by-case evaluation of NDAs and BLAs.

My column argues for a more systematic approach to addressing the needs of patients meeting three conditions:

• Their disease is progressively debilitating and/or fatal (i.e., they legitimately cannot wait for safer and more effective treatments to be developed and approved),

• They are willing to take on a lot more “safety risk” and “efficacy uncertainty” for even the slightest chance of a benefit, and

• They are dealing with complex heterogeneous diseases that, regardless of patient population size, will make drug discovery and development difficult.

If prompted, I hope the WSJ would see it the same way I do. They should advocate for the resolution of the current disputes in the context of—and as a step toward—reducing and narrowing the uncertainty that will otherwise be at the heart of future conflicts. Sponsors (companies) and patients would greatly appreciate more comprehensive guidance from the agency.

If any FDA Matters subscriber can help bring my perspective to the attention of the WSJ Editorial Board, please assist me in doing so.

Q&A - August 11, 2025

Dear FDA Matters subscribers Q&A Monday is a subscriber-first feature of FDA Matters. It is on the record, so subscribers (including reporters) can use and circulate the Q&A immediately upon receipt.

Subscribers are encouraged to submit questions about any aspect of FDA’s mission, responsibilities, programs, and policies to: sgrossman@fdamatters.com. I will try to respond to questions in a way that makes all of us a little smarter about FDA.

Have a great week,      Steven

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Recent columns:  

Short Takes and Updates August 8, 2025 covering

• The Difficult Path to An FDA that Is “Just Right,”  Neither Too Hard Nor Too Soft

• Former FDA Commissioner David Kessler Submits Citizen’s Petition Calling for Action on Ultra-Processed

Needed: A National Agenda for Advancing Therapies for Chronic Progressive Diseases (July 31, 2025)

Short Takes and Updates July 25, 2025, covering

• Imminent Danger Regarding Food Priorities

• New CDER Leadership

• Re-Exploring Reconciliation Cuts’ Impact on FDA Consumer Protection Responsibilities

 Food User Fees: The Good, The Bad...and the Possibilities (July 14, 2025)

Recent Linked-In and Other Exchanges:

·        Dr. Prasad’s Return--Comment on STAT Article

·       Dr. Prasad’s Return--Grossman Quoted In BioSpace Article

·       Former FDA Commissioner David Kessler Submits Citizen’s Position Defining Ultra-Processed Food

·     Comment on Montana’s Efforts to Expand Right to Try

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This week’s questions:

·       Were you surprised by  Dr. Prasad’s return to the agency?

·       How important is Dr. Kessler’s citizen’s petition and why do you think it moves the needle on the ultra-processed foods debate?

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Q: Were you surprised about Dr. Prasad’s return to the agency?

A: Yes. Resigning under pressure from the White House and being brought back 10 days later is extraordinarily rare. When Commissioner Makary publicly called for Dr. Prasad’s return, I rated the chance of this occurring as no more than ten percent ...and I  considered that an optimistic assessment. So, I was wrong, but the odds were heavily stacked against Dr. Prasad’s return. As Will Roger said: (Trump aside) “there are no second acts in American politics.”

Here is a statement I sent to the press after the announcement of Dr. Prasad’s return: “It takes time for an outside critic to turn into an inside decisionmaker. So, I am guardedly optimistic that he is returning chastened by the realization that neither the CBER director nor the FDA commissioner can make decisions in a vacuum. Lives are at stake. There are multiple stakeholders, notably patients and companies, as well as the President and Congress. They are all paying attention.”

The two columns I have written since he left office might also contribute to his education. The first was published July 31 and the second was published August 8.

·      Needed: A National Agenda for Advancing Therapies for Chronic Progressive Diseases” (bit.ly/46In13B) begins: “Every day, we are failing patients with chronic progressive neurological, neuromuscular, and genetic diseases.”

·       The Difficult Path to An FDA that Is “Just Right,” Neither Too Hard Nor Too Soft” (https://bit.ly/4m8HWl2). It critiques why Dr. Prasad was viewed by many as “too tough” on rare diseases, especially progressive diseases that limit human development (think DMD) or are fatal (think ALS).

Q: How important is Dr. Kessler’s citizen’s petition and why do you think it moves the needle on the ultra-processed foods debate?

A: For those not familiar with this question, I wrote about it last Friday at Short Takes and Updates August 8 2025.

So far, most of the MAHA effort has been to state goals--some seemingly outlandish, others merely ambitious--and then pressure states to adopt them and companies to acquiesce to them. The common element is that MAHA doesn’t get too specific or prescriptive about either the details or the actual steps to achieve the goals....and thus doesn’t stand in way of others acting, however disjointed the third party efforts may be.

The key is that they are avoiding (at least for now) the lengthy federal process for public input, consensus building, and rulemaking.

Consider:

·       Maybe the food industry can limit its sales of certain foods in West Virginia to avoid new legislation. But it won’t be able to do the same relative to pending legislation in big-market California

·      The Trump Administration has expanded the ways in which the government moves private players through threats and uses the bully pulpit. Food companies (wisely I think) have decided to promise to comply rather than face a drumbeat of bad publicity aimed at painting them as enemies of good health.

·      The Administration’s Request for Information on a definition of ultra-processed food (responses by September 23) is an important and necessary step but certain to produce a broad array of opinions. That will  further delay a federal position and continue to feed the “state laws and company volunteers” approach.

The Kessler petition cuts through all of that--saying not only that “the federal government should do this” but here is the definition, the supporting legal and scientific arguments, and the reason it’s important to act decisively.

Dr. Kessler, always a force to be reckoned with, has once again inserted himself into a public controversy and altered the debate. Whatever any of us think about the substance of the petition, it is pre-emptive of the potentially endless debate about whether there can and should be a viable federal policy on UPF’s.

Q&A - August 04, 2025

Dear FDA Matters subscribers–—“Q&A Friday” is now “Q&A Monday,” a subscriber-first feature of FDA Matters. It is on the record, so subscribers (including reporters) can use and circulate the Q&A immediately upon receipt.

Subscribers are encouraged to submit questions about any aspect of FDA’s mission, responsibilities, programs, and policies to: sgrossman@fdamatters.com. I will try to respond to questions in a way that makes all of us a little smarter about FDA.

Have a great week,      Steven

——

Recent columns:  

Needed: A National Agenda for Advancing Therapies for Chronic Progressive Diseases (July 31, 2025). This is a particularly important column. Please read it and forward it to others in your network.

• Short Takes and Updates July 25, 2025

• Food User Fees: The Good, The Bad...and the Possibilities (July 14, 2025)

Recent Linked-In and Other Exchanges:

Sarepta and FDA

Dr. Prasad’s Departure

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This week’s Q&A Monday features these questions:

·      What is FDA’s most pressing top-down need over the next few months?

·      Does USDA’s plans to move more staff to regional centers have any consequences for FDA?

·      Why did you choose to write about the need for better understanding and tools to evaluate chronic progressive diseases that are severely disabling or fatal?

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Q: What is FDA’s most pressing top-down need over the next few months?

A: Stability of leadership is the agency’s most pressing top-down need. (Note: The most pressing bottom-up need is to decrease staff turn-over, improve morale, and re-establish efficient workflow. Stability of leadership would help.)

On several occasions I have talked about how Commissioner Makary (and then subsequently Dr. Prasad) was an “outside critic who would have to go through a transition to take on the role of inside government decisionmaker.” Commissioner Makary is still in the middle of this--testing different approaches to problem-solving and leadership. That’s understandable and not meant as a criticism.

Dr. Prasad didn’t have the months to think about his new role--as Dr. Makary did; nor was it a good idea to give him even more responsibilities (chief medical and scientific officer) upon arrival. He apparently overturned several staff recommendations despite having criticized his predecessor, Peter Marks, for doing it at all. Likewise, as I examined in my last column (Needed: A National Agenda for Advancing Therapies for Chronic Progressive Diseases), he made several missteps with his handling of Sarepta. I would like to think that reflected his inexperience in the role rather than any hostility toward cell and gene therapy.

At this point, the FDA’s top leadership is thin, especially given the agency’s span of responsibilities and how many members of the team are new to their roles and new to working within the government.

One way to stabilize the leadership situation quickly would be to fill some of the vacant senior positions with individuals already at the agency and with experience in running it. Not acting appointments, but rather permanent ones. This should help stabilize things and, also, should help improve morale among career civil servants.

Q: Does USDA’s plans to move more staff to regional centers have any consequences for FDA?

A: I don’t think so, but it is a matter of concern and something to be watched (e.g., traditionally Congress has played a role and is, at least momentarily, inserting itself into this one). I have been told that 90% of USDA staff are already outside of the DC area. So, the alleged rationale of moving the agency closer to its constituents seems bogus.

Further, this type of action is often undertaken with the hope of shrinking the workforce because a lot of people will resign or retire instead of moving. About 15,000 USDA employees have already left (early retirements, RIF’s, etc.), so it would seem that forcing a few more departures will not have much of an impact.

I am curious if any FDA Matters subscribers can offer more insight into this topic.

Q: Why did you choose to write about the need for better understanding and tools to evaluate chronic progressive diseases that are severely disabling or fatal?

A: For those that missed it: Needed: A National Agenda for Advancing Therapies for Chronic Progressive Diseases. It is one of my most important columns.

FDA’s support has been an essential feature of forty years of progress in stimulating new understanding of rare diseases and the approval of countless drugs to treat and sometimes cure rare diseases.

Yet, within the agency there is a constant tug-of-war about how to address the subset of patients with progressive debilitating and fatal diseases. Compassion and exceptions to the rules are doled out unevenly and, I suspect, inconsistently. Some sense of the agency’s approach; some guidance to patients and industry; and clarity on how, as a class, treatments are evaluated for these diseases. It doesn’t seem too much to ask, even if it requires confronting some difficult issues.

The cause of patients with debilitating and fatal diseases has been taken up by libertarian-oriented organizations that see it as way to move toward “anything goes” drug approvals. FDA needs to have a strong, pro-patient view on how to help patients with these mostly rare diseases without opening the floodgates for a free-for-all.

Q&A - July 28, 2025

Dear FDA Matters subscribers–—“Q&A Friday” is now “Q&A Monday” so that I can thoughtfully answer questions based on the past week’s news. It is on the record, so subscribers (including reporters) can use and circulate the Q&A immediately upon receipt.

Subscribers are encouraged to submit questions about any aspect of FDA’s mission, responsibilities, programs, and policies to: sgrossman@fdamatters.com. I will try to respond to questions in a way that makes all of us a little smarter about FDA.

Have a great week,      Steven

——

Recent columns

• Food User Fees: The Good, The Bad...and the Possibilities (July 14, 2025)

• Short Takes and Updates July 25, 2025  

Recent Linked-In and Other Exchanges: 

• Does Shortening Drug Reviews Risk A Thalidomide-Type Situation

• Clinical Leader Reprints My “All of Us Need to Be Rooting for FDA”  

• Sarepta Exchange: Steven’s Comment On Herper Article

• Briefing on GLP-1’s

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This week’s “Q&A Monday” features questions on:

• Is there a “revolving door” issue with Dr. Tidmarsh’s appointment as head of CDER?

• Why is the Administration so apparently indifferent to the need for national investment to avoid falling behind China in the life sciences?

• What is an important story that is not being widely discussed? (FDA’s headcount)

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Q: Is there a “revolving door” issue with Dr. Tidmarsh’s appointment as director of CDER?

A: I addressed this indirectly in my Short Takes column this past week (here) by pointing out the many similarities in view and style among Commissioner Makary, CBER director Prasad, and Dr. Tidmarsh.

I would expect CDER policy under Dr. Tidmarsh to be closely aligned with the Commissioner’s view that FDA should cut drug review times dramatically through greater efficiencies, while not compromising safety. I hope that Dr. Tidmarsh will extend that thinking to include speedier review of generics, biosimilars, and OTC monographs.

I do not think FDA is corrupted by individuals moving in either direction between FDA and industry. Whatever the image of this exchange might be, the reality is that almost all FDA decisions reflect the input of multiple people. No one FDA staff person can give industry an undeserved benefit and not have it widely known and discussed.(see Picking Apart the Claims That FDA Controls Industry).

Q: Why is the Administration so apparently indifferent to the need for national investment to avoid falling behind China in the life sciences?

A: In my column entitled:  “Elon Musk and the Future of Government Investment in Our Nation’s Future,” I looked generally at the retreat from government investment for our nation’s future. Subsequently, I have come to realize Elon Musk was just the public face, albeit a most enthusiastic one. The ongoing influential voice in this debate is really Russell Vought, the head of the Office of Management OMB, who was the author of the Project 2025, a blueprint for downsizing government. He’s not going away any time soon.

To the narrower question of investment in the life sciences, I have been mystified. Early in the year, even when slashing budgets and cutting staff seemed to consume all other priorities, I still expected that life sciences investment would be minimally affected. That proved not to be the case for NIH (in terms of dollars) or FDA (in terms of retained staff). Apparently, cost-cutting did consume all other priorities, including the need to invest in projects that keep us ahead of China.

Attitudes toward competition with China have started to shift, albeit slowly. Commissioner Makary’s National Priorities Voucher (NPV) initiative aims to encourage re-shoring of manufacturing, and you can start to see the beginning of efforts to stimulate development of drugs and biologics by shortening review times.

Until proven otherwise, current obstacles to cutting edge cell and gene therapy should be looked at as situational and transitional, rather than policy driven. We will just have to wait and see if that is true.

There appears to be a growing concern about competition with China that goes beyond the traditional issues: balance of trade, tariffs, rare earth materials, and naval dominance. One important voice for turning the spotlight onto life sciences is the National Security Commission on Emerging Biotechnology (NSCEB), which released a report in April. 

Q: What is an important story that is not being widely discussed?

A: The current state of the FDA workforce is important to all stakeholders, but the total headcount appears to be unknown outside the agency. My column on this topic from three months ago is here.

Relative to December 2024, we know the workforce has been reduced by lay-offs, RIF’s, and voluntary separations (whether a response to incentives or in advance of being RIF’ed or natural attrition as people leave the agency for other opportunities).

In the other direction, the decreases in the workforce at the agency have been offset by those asked to return after a RIF notice and the unexpected start of new hiring. I also suspect--although I have no proof--that some of the planned 3500 RIF’s were rescinded before being issued.

It would help to know: FDA has funding for xx,xxx of FTE (full-time equivalent) employees as of July 15, 2025, of which x,xxx positions are currently vacant and are expected to be filled.

Without that--we have no way to assess whether anagency delays (across the agency, not just drugs and biologics) are the result of understaffing, open vacancies, or situational delays that are normal and to be expected.

Q&A - July 18, 2025

Dear FDA Matters subscribers–—Each “Q&A Friday” will go to subscribers first, then posted on the website a week later. It is on the record, so subscribers (including reporters) can use and circulate the Q&A immediately upon receipt.

Subscribers are encouraged to submit questions about any aspect of FDA’s mission, responsibilities, programs, and policies to: sgrossman@fdamatters.com. I will try to respond to questions in a way that makes all of us a little smarter about FDA.

Have a great weekend,      Steven

·       If you were away the week of July 7: FDA in a Post-Reconciliation World

·      July 18: Food User Fees: The Good, The Bad...and the Possibilities

·       Linked-In exchanges: National Priorities Vouchers and Unmet Medical Need, More on Health Canada and GLP-1’s, and Join the discussion on Food User Fees.

Q&A FRIDAY—July 18, 2025

This week’s Q&A Friday features questions on:

·       the FDA panel on HRT therapy,

·       the OTC Monograph user fee reauthorization

·       FDA action on standards of identity for food.

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Q: What do you think of this week’s FDA panel on HRT therapy for menopausal women?

A: I like the quick elevation of an important issue, which should hasten its resolution. I like the fearlessness in taking on a long-standing and widely-debated medical controversy.

The process, however, has been deficient on so many levels that it is hard to know how much credence to give it. Poor adherence to process renders any conclusion highly suspect.

While FDA’s traditional advisory committee system is time and labor intensive and can be slow, it has served FDA very well for many years.

It’s not a perfect system. However, there is a degree of confidence in the results....solely because of the due diligence which is at the core of the required process. Committee members are chosen for their varied views and experiences; then vetted for conflicts; meeting notices are usually released early; briefing books are available three days before the meeting; FDA presents its position; and there is a public comment period and public deliberation over a variety of views.

None of these steps were followed in convening the HRT review panel (NY Times story). Since norm-breaking in general--and a lack of commitment to process in particular--are hallmarks of the Trump Administration (my column here), we can expect more FDA meetings will use this truncated process.

Nonetheless, I am hopeful that a return to regular processes may eventually occur at FDA, at least some of the time. Prospectively following protocol (e.g., the Federal Advisory Committee Act) can be time-consuming, but the alternative (expert meetings with no balance, no vetting for conflicts, and no FDA presentation) lacks the credibility that has been the hallmark of the FDA’s past actions.

We should wait to see whether this experiment stands the test of time. If the meeting results aren’t readily accepted, then maybe the old FDA advisory committee process might start looking good to FDA’s new leadership.

Q: Is there any current issue that you feel is not getting the media attention it deserves?

A: Yes, the reauthorization of the OTC Monograph User Fee program, which must be enacted into law before October 1, 2025. Discussions have started in the House Energy and Commerce Committee on a pending bill, and I know of no threat to the reauthorization that would prevent the renewal from occurring.

What seems uncovered is the question: how will the discussion around the OMUFA renewal impact the just-starting-to-be-discussed reauthorization of the biggest user fee programs? That process must be completed in time for the President to send a proposal to Congress by January 2027 (18 months from now).

Q: What are standards of identity--why do we have them, why is FDA withdrawing some now?

A:  As is often the case, Food Safety News, one of the best publications to have in your inbox every morning (and free), summed up the situation well:

“The FDA began establishing Standards of Identity (SOI) in 1939 and has since put into place more than 250 of these consumer protections. Products including milk, milk chocolate, various breads, peanut butter, and ketchup have an SOI. The standards often describe in detail what a food must contain and what is optional and sometimes describe the amount or proportion of ingredients or components. Many SOIs also prescribe a method of production or formulation. The goal of the plan to revoke SOIs is to permit the food industry flexibility of the covered foods.” (here)

This sounds good--get rid of obsolete regulations, provide industry flexibility, and continue to protect consumers with SOI’s that are current and needed. So far unmentioned (and unanswered) is a tongue-in-cheek question: Does this action enable five new, presumably needed, regulations to be advanced under the Administration’s standard of getting rid of ten regulations for every new one?

In a recent column (here), I explored how massive cuts to Medicaid, SNAP, and other health and feeding programs are likely to lead to increased consumer fraud in food and medical products.

In light of that, I hope this action--which has been presented as removing obsolete SOI’s--is not the opening salvo in diminishing FDA’s crucial consumer protection role. We need FDA to prepare for a darker world with more incidents of intentional adulteration of foods. As Americans, we cannot afford any weakening of FDA’s inspections and enforcement policies, or any diminishment of the staff assigned to these responsibilities.

Q&A - July 11, 2025

Dear FDA Matters subscribers–—Second edition of Q&A Friday, a new feature for subscribers. Each “Q&A Friday” will go to subscribers first, then posted on the website a week later. It is on the record, so subscribers (including reporters) can use and circulate the Q&A immediately upon receipt.

Subscribers are encouraged to submit questions about any aspect of FDA’s mission, responsibilities, programs, and policies--to: sgrossman@fdamatters.com.  I will try to respond to questions in a way that makes all of us a little smarter about the agency.

Steven

Postings this week:

·       If you were away the week of July 4: All of Us Need to Be Rooting For FDA

·       July 8: FDA in a Post-Reconciliation World

·      LinkedIn exchanges on compounding: Pharmacist view and Health Canada

·      LinkedIn exchanges on food safety and consumer protection after reconciliation: here and here.

Q&A FRIDAY

I am using this week’s Q&A Friday to ask myself some questions about topics and positions that were covered in the forty columns since our launch on January 10, 2025. This should be especially useful for the many subscribers who have signed up recently.

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Q: What is the farthest reaching, most consequential idea that you have advanced in FDA Matters?

A: I would offer up this observation from The Skeptical Enthusiast’s Guide to AI at FDA:  

“When the Clinton administration downsized the federal government in the 1990’s, some of the success of that effort was attributable to embracing new technology. The Internet was gaining traction and there was the opportunity to create efficiencies in government around that then-new technology. A similar opportunity exists today for AI to play a role in making the US government more efficient.”

Then, as now, there is resistance to technological transformation based on fear, uncertainty, and lack of appreciation of the profound and positive changes that are possible. That there is precedent for technological transformation in government should make it easier to accept.

I applaud Commissioner Makary for understanding this opportunity and moving forward enthusiastically......whereas I sense a lot of lip-service from many other government officials.

Then, as now, we need to appreciate that we are working with a technology whose capabilities, strengths and weaknesses are formative, not set. There is an almost irresistible impulse to oversell how far along we are.

We are in the top of the 1st inning or bottom of the 2nd inning in a nine-inning game of AI development and adoption. I would love to see an FDA  plan that recognizes we are in the early phases and articulates next and future actions to achieve full integration of AI at FDA.

Q: What concept has been the most useful in explaining FDA during H1/2025?

A: I became a big fan of Chesterton’s Fence (Chesterton’s Fence and the Meaning of Deregulation and Other Thoughts About FDA). The concept is “don’t take down a fence until you know why it was built in the first place.” The goal is to promote thoughtfulness; not to suppress change.

It popped up a number of times this spring as a way to underscore what was wrong with arbitrary RIF’s and the decimation of many government functions that seemed essential.

In some cases, people were later recalled but it is hard to see how “random returns” beats “prospective planning.” For example, if a major theme of the new Administration is combatting chronic diseases, then why wipe out the CDC National Center for Chronic Disease Prevention and Health Promotion?[1] Similarly, if your goal is to improve nutrition and eliminate certain types of food additives, then laying off top employees in FDA’s Human Foods Program and forcing out Dr. Kevin Hall, NIH’s lead nutrition researcher,[2] looks more like self-sabotage than a plan to achieve success.

As described in the first question, the Reinventing Government effort led to a substantial downsizing in the federal work force over a period of several years. However, it followed Chesterton’s Fence....starting with what government should do and how each department and office contributed to those goals.

Q:  A subscriber asked: your June 30 column, “All of Us Need to Be Rooting for FDA” (here) is an interesting take. Are you hearing a lot of stakeholders rooting for FDA failure?

A: I have not heard anyone actively rooting for FDA failure. However, there is a lot of unhappiness and doom-prophesizing that sometimes feels unrestrained and unconditional rather than measured and constructive. Often, it is heedless of the context in which Commissioner Makary must operate. Sometimes it feels like agency failure is the desired outcome....without any apparent self-awareness of how destructive that would be.

 No one in government should get a free pass--as FDA Matters columns will continue to demonstrate. I would add: we need continued dialogue among all stakeholders and the FDA that reflects that an effective, efficient, and fair FDA is a universal goal.

[1] The proposed merger into the Agency for a Healthy America is neither a good nor bad idea so much as one that will be less effective, less efficient, and could fail unless Chesterton’s Fence is applied. Useful background: https://www.statnews.com/2025/06/04/cdc-chronic-disease-center-folded-into-new-uncertain-home-administration-healthy-america/ [2] He was asked back later--after the error was pointed out--but he was not convinced that his work could be advanced without bias. https://www.statnews.com/2025/05/16/nih-kevin-hall-ultraprocessed-foods-nutrition-censorship/

Have a great weekend,

Steven

Q&A - June 26, 2025

Dear FDA Matters subscribers–

Introducing Q&A Friday, a new feature for subscribers.

Each Friday’s Q&A will go to subscribers first, then it will be posted on the website about a week later. Like all FDA Matters analysis (including everything on the website) it will be on the record, so subscribers (including reporters) can use and circulate the Q&A immediately.

To maximize the value of this effort, please send your toughest questions--about any aspect of FDA’s mission, responsibilities, programs, and policies--to: sgrossman@fdamatters.com.

I will try to respond to questions in a way that makes all of us a little smarter about the agency.

Steven

Q: Do the efforts to dramatically shorten the approval process risk a thalidomide-type situation with no place for a Frances Kelsey to express concerns?

A: There are many FDA programs that work to shorten biopharmaceutical and medtech review times. Commissioner Makary has just announced another one, the National Priorities Voucher Initiative (NPV), that aims to create a significantly faster pathway by focusing on rolling reviews, enhanced communications with the agency, and rapid implementation of AI systems.

Usually, FDA, companies, and the public are aware--well in advance and long before the NDA filing--that the FDA’s review for approval is likely to generate deeper discussions. The change to a two-month accelerated review would still have to account for earlier, as well as contemporary public critiques from study investigators, review boards, clinicians, investment analysts, mandatory SEC disclosures, and FDA reviewers.

For new chemical entities, there should be additional critique from an FDA advisory committee, although it is unclear how advisory committee review fits into the timeframes for the recently announced NPV initiative.

We only know in retrospect that Dr. Kelsey’s was correct in blocking the approval of thalidomide in 1960. So, I can’t say that a latter-day “Francis Kelsey” wouldn’t “win some and lose some” when concerns are being raised prospectively. However, unlike 1960[1], there would be plenty of opportunities for her to voice her concerns publicly and stimulate additional evaluation of the data.

For additional relevant information about FDA’s decisionmaking process, I would recommend the last section (“FDA Is Not So Easy to Influence”) in my earlier column here.

Q: What is the starting point of the next round of negotiations on medical products user fees?[2]

A: The current user fee agreements will expire on September 30, 2027. Hearings start this summer. That gives negotiators about 15 months to reach agreements, which will then be debated by Congress in early 2027.

Based on HHS Secretary Kennedy’s persistent criticisms of FDA/industry relationships, echoed to a degree by Commissioner Makary, I have assumed the Administration will insist on a different structure that it will claim does a better job of insulating the FDA from industry influence.

Commissioner Makary seems to have softened his stance recently, talking a lot about working with industry and supporting a budget request that implies continued user fees. This may be an acknowledgement that FDA cannot sustain itself on appropriations alone. Also, as Commissioner, he may have a greater appreciation of why medical advances are dependent on the cooperation of the agency, patients, and industry.

Negotiators will need to account for the strength and proven durability of the current user fee structure. Improvements are possible, but some new approaches may look good at first glance but may not prove better in practice.

Old and proven structures, new sensitivities....it’s not yet clear how that will play out.

Q: With regard to the new National Priorities Voucher initiative (NPV), you liked some aspects but “worry about diluting the focus on unmet medical needs.” Why does this concern you?

A: Existing accelerated review programs are gated by a requirement that the products being reviewed address an unmet medical need. It is less clear whether that would be the case under the NPV. As described by FDA:

“The FDA Commissioner will use specific criteria to make the vouchers available to companies that are aligned with the national health priorities of:

Addressing a health crisis in the U.S.

Delivering more innovative cures for the American people.

Addressing unmet public health needs.

Increasing domestic drug manufacturing as a national security issue.”

The program is being created with noble intent. Nonetheless, it seems to me that a speedy FDA review is not an appropriate lever for rewarding activities that are not related to safety, efficacy, or unmet medical need.

Reshoring manufacturing plants or committing to limit price increases are worthwhile national priorities, but neither has anything to do with approvals. I might soften on this when more details become available on the NPV, but at least initially I find it troubling.

Note: Thanks to everyone who submitted this week’s questions.

HPS Group, my consulting firm, is accepting new clients and projects. While FDA Matters will always be a work in progress (new columns and new features coming), I can now turn my attention to the re-launch of my consulting firm, HPS Group.

Let’s chat about whether we can help...if I can’t offer you what you need, I have worked with a vast number of people I can recommend. You can reach me at sgrossman@hpsgroup.com or at 301-257-9660.

Have a great weekend,

Steven

1. https://en.wikipedia.org/wiki/Frances_Oldham_Kelsey

2. Tobacco user fees are excluded because they are permanent, i.e., not re-negotiated every five years and because the industry/FDA relationship in tobacco is completely different than in medical products.

Q&A - June 20, 2025

Dear FDA Matters subscribers--

There was one FDA Matters column this week. Alice, Humpty Dumpty and the New Administration, in which I explored the meaning of radical transparency, gold-standard science, and ultra-processed foods.

I also posted a comment (here) on the new National Priorities Voucher (NPV) initiative at FDA. When we have more details, I will probably produce an entire column about it.

Looking for Questions from Readers. When I wrote “Friday Update” for the Alliance for a Stronger FDA (about six hundred columns over 15 years), some of my best-read columns were in response to questions I received from Alliance members.

In that same spirit of give and take, I welcome questions from FDA Matters’ subscribers (including members of the media). Please send your toughest questions about any aspect of FDA’s mission, responsibilities, programs, and policies to: sgrossman@fdamatters.com.

I will try to respond in a way that makes all of us a little smarter about the agency. As a “for example,” I was asked yesterday whether I thought all the efforts to shorten the approval process risked a thalidomide-type situation with no place for a Frances Kelsey to express concerns. I have an intriguing answer...which I will share in the first FDA Matters Q&A column.

HPS Group, my consulting firm, is accepting new clients and projects. While FDA Matters will always be a work in progress (new columns and new features coming), I can now turn my attention to the re-launch of my consulting firm, HPS Group.

I am a policy analyst, problem solver, and writer with deep experience in FDA and NIH issues and an insightful perspective on advocacy in DC.

At various points, I have done coalition development, strategic plans, built and implemented communications and public affairs programs, and written op-eds and white papers. I have worked in and for associations, in the Senate, at HHS, and at a large public relations/public affairs company. I have been an independent consultant for many years, including while I was at the Alliance.

You may retain HPS Group to provide ongoing counsel or ask for assistance with specific projects from reviewing documents to long-term planning. If it’s challenging, I am up for it...even if it is only a small, short-term assignment helping you think through a problem.

Let’s chat...if I can’t offer you what you need, I have worked with a vast number of people I can recommend.

You can reach me at sgrossman@hpsgroup.com or at 301-257-9660.

Have a great weekend,

Steven