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