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NCHR Public Comment on Improving the Generic Drug User Fee Act (GDUFA IV)

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NCHR Public Comment on Improving the Generic Drug User Fee Act (GDUFA IV), August 11, 2025


Re: Reauthorization of GDUFA Amendments Public Comment from National Center for Health Research [Docket No. FDA-2025-N-0873]

The National Center for Health Research is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products, and we do not accept funding from companies that make those products or have any financial interest in our work.  Since our founding in 1999, we have focused on FDA policies and issues pertaining to the quality of medical care and are pleased to have the opportunity to share our views on improvements needed for GDUFA IV.

Our U.S. healthcare system relies on generic drugs and would be unaffordable without them. We wish Congressional appropriations would be sufficient to support all of the FDA’s essential work, but we know that the FDA needs user fees to ensure getting safe and effective medical products to market in a timely manner. However, speed is not the most important part of that equation.

In its summary of its request for public comments, the FDA stated that GDUFA is designed to facilitate timely access to safe and effective generic drugs for the public, by requiring that generic drug manufacturers and other relevant entities pay user fees to “finance critical and measurable generic drug program enhancements.” As described in the GDUFA III Commitment Letter, FDA committed to achieve certain performance goals, and to provide enhancements “designed to foster the development, assessment, and approval of complex generic products.”

Transparency

We appreciate the accomplishments of GDUFA III, but to achieve its stated goals GDUFA needs to be improved in ways that matter to patients and the U.S. healthcare system. We support recent HHS and FDA statements about transparency and about the need for the FDA to regulate industry, rather than to be influenced by unduly cozy relationships with industry.  An important first step would be for user fee negotiations to include patient, consumer, and public health advocates, instead of only representatives of industry and the FDA negotiating behind closed doors.  Unfortunately, all user fee negotiations have focused on what industry wants and needs and what they are willing to pay for, and not on what patients and consumers want and need. That needs to be improved, and no user fee programs are more important to patients, consumers, and healthcare in the U.S. than GDUFA.

All of us depend on generic drugs, whether taken for headaches or potentially deadly cancer or heart disease.  Patients have been told to trust that generic medications work, but if our experience with a specific generic drug is inferior to what we previously experienced with the brand name version of the drug, our trust in all generic drugs can be harmed. In some cases, problems with specific generic drugs have been well-documented. That has happened too often in recent years, and that is why patients’ and health professionals’ trust in generic drugs has eroded. GDUFA needs to explicitly show that user fees will focus on ensuring that generic drugs are truly equivalent to brand name treatments in all the ways that matter to patients.  Speed should be secondary, because when patients and health professionals realize that some generic drugs are ineffective or unsafe, it harms patients but also harms companies whose products are safe and effective.

Performance Goals

Performance goals need to be improved. Too few have been focused on safety or effectiveness.  We are glad that metrics have included the number of inspections and timeliness of inspections and follow-up warning letters, import alerts, and regulatory meetings, and those metrics should be continued.  However, they are not sufficient.

Last summer, the FDA determined that Synapse (a company in India) “faked and forged” data submitted to the FDA. FDA withdrew the bio-equivalency rating of 400 of their drugs, but they are apparently still on the market.  Neither patients nor pharmacists have access to the names of those drugs.  Why is that?  That decision is terribly unfair to patients, but it is also unfair to companies whose safe and effective generic medications are competing with those 400 drugs.  

More important, it is unfair to all generic companies that make excellent medications when patients don’t know which generic drugs they can trust, and which they can’t trust.

Valisure has also conducted research showing a sizable number of generic drugs are substandard, with doses that are too high, too low, or drugs that are contaminated or have other problems. That’s important information for consumers to know, so the FDA should follow-up on Valisure’s findings to get those drugs off the market.  However, it is equally important that the agency should be on the forefront of conducting that type of research, requiring recalls of those inferior drugs, and warning patients that those medications need to be replaced with those made by a different generic or brand name company. If the FDA does not have sufficient staff to do that, they should hire additional staff, and GDUFA should help to make that possible.

These are just a few examples of why post-market surveillance, pre-market and post-market inspections, and re-inspections are so important and why GDUFA should include funding for staff who will accomplish those quality performance goals.  GDUFA should include relevant metrics in the Commitment Letter that show that these problems are being addressed and that FDA can therefore ensure that generic drugs are truly safe and equivalent to brand name drugs. That’s the promise that GDUFA and the FDA have made to patients, and it needs to be kept.  

Here is an important list of the kinds of metrics that are missing from previous GDUFA Commitment Letters and should be included in FDA monitoring under GDUFA IV.  They are not new ideas; this is the exact same list that the FDA states are criteria for all generic drugs.  The FDA says they must be:

  • Pharmaceutically equivalent
  • Capable of making the drug correctly
  • Capable of making the drug consistently
  • The active ingredient is the same as the name brand and the same amount gets in the body
  • Inactive ingredients are safe
  • Drug does not break down over time

We appreciate the progress that has resulted in reducing the backlog of generic drug applications.  However, many patients and knowledgeable health professionals currently lack confidence in generic drugs, and in some cases their concerns are well-founded. To regain public trust, we respectfully urge the FDA to improve GDUFA by adding performance goals metrics that are focused on ensuring safety and equivalence in GDUFA IV in the ways recommended above.

We would welcome the opportunity to discuss these issues and answer any questions.  We can be contacted at info@center4research.org.

Medical device industry says future MDUFA hikes unsustainable

In the News, News Stories & Editorials, We're In the News

Elise Reuter, MedTech Dive, August 5, 2025

Medical device companies advocated against future increases to user fees at a public hearing Monday for the next medical device user fee amendments. Meanwhile, Food and Drug Administration leaders, facing congressional budget cuts, made a case for more user fees, emphasizing the importance of the program.

The five-year agreement determines the amount the FDA can raise from the medtech industry to supplement congressional appropriations. In the current MDUFA program, which ends in September 2027, the FDA’s device center negotiated a boost in user fee funding in exchange for meeting certain review timelines and staffing levels. The next agreement would take effect in October 2027 and run through 2032. 

Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, said the FDA “requires sustained and increased investment by the medical device industry” to meet its goals. The device leader added that “holding steady does not lead to excellence — it leads to mediocrity.”

However, device industry lobbyists at the meeting indicated a preference for few changes.

“Each MDUFA cycle included significant resources and investments, including increasing the number of [full-time employees] to support the program,” said Janet Trunzo, senior executive vice president of technology and regulatory affairs for AdvaMed. “Now that we have approached nearly 25 years … of user fee programs for medical devices, we are now in a position of merely fine-tuning the current program.”

Mark Leahey, CEO of the Medical Device Manufacturers Association, called for the process to return “back to the basics” in comments on Monday. Leahey said the funds from MDUFA should go to reviewers and medical officers, and added that the industry wants more visibility as to where the funds are going and “where people are right now, realizing there’s been some attrition over the last six months.”

Citing the latest user fee rates, Leahey said more than $427 million in fees were authorized for fiscal year 2026.

“We have to realize the size and scope of the investments here,” he said. “And this is not a sustainable pathway.”

The meeting kicked off a process where the FDA will seek public comment through Sept. 4, before beginning negotiations with industry. When a final agreement is reached, the FDA will present it to Congress, which must approve the next MDUFA program.

[….]

Patient advocates call for more fees, transparency

While industry pushed back against further fee increases, patient groups called for more fees to offset federal budget cuts to the FDA. Diana Zuckerman, president of the National Center for Health Research, said that given recent cuts in FDA staffing and the importance of speedy device reviews, “it’s inevitable that improving quality requires increasing the fees.”

Zuckerman said that while she would like to see Congress provide enough appropriations for the FDA’s device center, “we want to make sure that there’s funding for everything that’s needed, and, unfortunately, appropriations isn’t making that possible.” 

Zuckerman also called for user fees to be used for postmarket device safety, as well as for more transparency during the negotiation process, positions that were supported by other patient advocates during the meeting. 

In the past, user fee negotiations have been behind closed doors, and patients, consumers and health professionals have not been able to join or observe the meetings, Zuckerman said. In the last round of negotiations, the FDA also faced scrutiny for not publishing meeting minutes from its conversations with industry in a timely fashion. 

“At the very least, we should have access to remotely watch those negotiations, instead of just depending on minutes that are often vague or very delayed so that stakeholders have no opportunity for meaningful input,” said Tess Robertson-Neel, on behalf of the Patient, Consumer, & Public Health Coalition, a group of more than two dozen nonprofits. 

Robertson-Neel added that user fees should be increased, and the FDA should focus on being “more patient-centered and transparent and less cozy with industry.”

Alexander Naum, policy manager for Generation Patient, a nonprofit representing young adults living with chronic medical conditions, said that user fees must increase and the next MDUFA agreement should include clear postmarket device safety performance goals. He also asked for the FDA to commit funds to expanding its program for tracking medical device adverse events. Naum cited a statistic that the FDA receives more than 2 million reports annually of suspected device malfunctions, serious injuries or deaths.

“So many of us rely on medical devices for our survival,” Naum said.  “Many of these devices present the potential of unexpected adverse events.”

Read the article in MedTech Dive here.

FDA Public Meeting on MDUFA VI: Invited Presentation of Dr. Diana Zuckerman

Policy, Testimony & Briefings

August 4th, 2025

I’m Dr. Diana Zuckerman, president of the National Center for Health Research, a patient-centered, evidence-based public health think tank. Our Center is very involved in FDA issues pertaining to the safety and effectiveness of medical products, and I appreciate the opportunity to share my views today. My perspective is as a scientist trained in epidemiology and public health, and also as a patient with three implants in my body.

MDUFA performance measures have focused on speed, but they should also evaluate whether patients are protected from ineffective or unsafe products. All FDA user fees have performance goals that emphasize speedy reviews and FDA staff being available for meetings with companies to help them understand what they need to do to obtain approval or clearance. That makes sense –industry is paying for something that they want.

However, PDUFA uses a much greater percentage of its user fees for post- market surveillance and safety analysis, compared to MDUFA. All user fee negotiations are behind closed doors and patient, consumers, and health professionals are not allowed to be there or even to observe. We should be part of the process. Instead, we’ve been told that in past MDUFA negotiations, CDRH asked that user fees help support these kinds of safety and quality issues but that industry refused. Equally discouraging, CDRH complied with industry’s refusal.

The MDUFA V Commitment letter shows what happens when patients, consumers, and health professionals are excluded. The letter sounds like parents telling their children what they need to do to earn their allowance. Statements starting with “FDA will do x or “FDA’s response letter will include y” were made “200 times in the Commitment Letter. There were just a few statements starting with FDA and industry will ___” and even fewer saying
what industry needs to do. This raises the question: Is Industry being regulated by FDA or do MDUFA agreements reverse that balance?

Why are performance goals all about what FDA has to do? Performance goals
should also be based on the types of accomplishments most important to patients, pre- and post-market.

Before FDA determines if a product can go on the market, CDRH lead reviewers are supposed to be like project managers who can rely on subject matter experts. But there aren’t enough subject matter experts. So, lead reviewers have to review the software, cybersecurity, electrical safety, biocompatibility etc. even if they don’t have that expertise. So, to meet their deadlines and keep their managers happy, many reviewers will assume criteria are met that they were not able to evaluate.

Those inferior reviews are common when a Commitment letter focuses on speed
of review, with no metrics for quality.

Let’s compare MDUFA commitments to user fees for other federal agencies, using the same analogy Congress used when it first passed FDA user fees. When we visit a National Park such as the Grand Canyon, we pay user fees (called entrance fees) to get in and those fees help pay for staff that keep the parks running. That’s in addition to the appropriations that all taxpayers pay. But those of us paying for admission don’t get to boss the Park Service
employees around. We don’t tell them what to do. We pay extra fees for food and lodging – shouldn’t the device industry pay extra for necessary inspections and post-market activities that help to make CDRH effective?

Bottom line: Entrance fees help ensure that parks function well, and MDUFA should help make sure CDRH functions well – by helping improve the quality of FDA reviews and the outcome for patients using devices.

Thanks to an analysis by Device Events, a company founded by a former FDA staffer, I can tell you that the number of adverse events more than tripled from 65,000 per month in 2015 to 225,000 per month this year (equivalent to 2.7 million/yr). Was that because of MDUFA pressure for speedy reviews? Some of these adverse events are very serious. In fact, this year so far, there have been 6,754 death reports to the FDA for medical devices. Let me give one example of a very common medical device, dental implants. There are 2.9 million adverse event reports for dental implants in MAUDE, and another 2.1 million that were included in summary reports, for a total of 5 million adverse event reports. But FDA has not held a public meeting for dental implants, nor has FDA provided public information about what those adverse events are or whether some types of dental implants may be safer or more effective than others. Everyone should have access to that information, and FDA should consider those specifics when it reviews new dental implants as well as those already on the market.

Since fewer than 5% of devices that FDA regulates provide clinical trials of safety or effectiveness before going on the market, it is essential that user fees should help pay for timely post-market reviews. That is especially important when FDA is being forced to speed up reviews and when staffing cuts have made reviews less thorough than they should be, and in-person inspections less frequent.

What kind of performance goals make sense for MDUFA?

CDRH lacks sufficient staff to review DTC ads, detailing activities, or ads to
doctors that directly or indirectly promote inappropriate off label use. User fees
should help pay for those activities.

User fees should also support FDA staff to create Patient Booklets, Informed Consent Checklists, and other materials that CDRH has used to help ensure that patients can make informed decisions. This is especially important when the device labels are intended for doctors, not for patients. User fees should also support Dear Doctor” letters, warnings to patients, and recall campaigns. PMA reviews should be rated on whether clinical studies are too small or too short-term. Safety and effectiveness data should be analyzed for male and female patients of different ages. Performance goals should also specify how many approvals were based on at least one randomized, controlled trial demonstrating robust evidence of a favorable benefit-risk profile. Post-market surveillance should sometimes result in FDA warnings, recalls, or withdrawals. Performance data should specify how often the FDA uses these mechanisms and the reasons for those actions.

What about the money?

MDUFA user fees are a fraction of PDUFA user fees, even for the largest device companies. The 510k user fees are too small to pay for a thorough speedy review, so either the review times need to be longer or the fees need to be greater. Given the cuts in FDA staffing this year, and the importance of speedy reviews to industry, it’s inevitable that improving quality requires increasing the fees. If those increases are adequate, it will still be possible for the FDA to waive fees for the smallest device companies, as they’ve done in the past.

A final word: User fees should be based on the average cost of each review. Past commitment letters have said the fees will be reduced if the number of applications exceeds expectations. That makes no sense at all – each review requires time and attention. FDA should reject industry demands that fees be reduced if more applications are received.

FDA ‘Expert Panels’ Raise Concerns of Evading Regulations, Ethics

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Do panels cherry-pick experts and evidence that align with FDA leadership’s views?

by Rachael Robertson, July 24, 2025

Bypassing its standard pathways for scientific discussions, FDA has recently held a slew of so-called “expert panels” that sidestep legal procedures and ethics guardrails, raising concern about cherry-picking of experts and evidence.

The panels appear to be a new feature of Trump administration officials, and have no parallel in agency programs from years past, sources said. They’re usually moderated by FDA Commissioner Marty Makary, MD, MPH, and FDA principal deputy commissioner Sara Brenner, MD, MPH.

There have been about four panels so far: one on selective serotonin reuptake inhibitors (SSRIs) and pregnancy; another on hormone therapyopens in a new tab or window for menopause; one on infant formula ; and another on talc in food, drugs, and cosmetics.

Adriane Fugh-Berman, MD, director of PharmedOut, a project at Georgetown University Medical Center in Washington, D.C., said she suspects these expert panels “may be a run around advisory committees,” which are usually vetted, occupationally diverse, academically credentialed researchers who address a particular question.

Fugh-Berman told MedPage Today that most of the panelists at the menopause meeting, which she attended as an audience member, would not have met the criteria to serve on an advisory committee.

“There was no process for selection; they seem all to have been chosen by Makary,” Fugh-Berman said. “It was a parody.”

Steven Grossman, JD, an FDA regulatory and policy consultant, also weighed in on the menopause expert panel on his FDA Matters blogopens in a new tab or window. He noted that the panel quickly elevated an important topic, although it completely veered from the advisory committee system, which while not perfect, “has served FDA very well for many years.”

However, convening the expert panel broke many norms, and “poor adherence to process renders any conclusion highly suspect,” he wrote.

Regulatory Grey Zone

The Federal Advisory Committee Act requires that advisory committee meetings be announced in the Federal Register 15 days in advance and that meeting materials must be made public. A period of open comment where anyone can speak is also necessitated under this law, explained Sarah Wicks, JD, MPH, an associate at Hyman, Phelps & McNamara.

She noted these panels “don’t seem to fit squarely within the scope of the law.” So far, they have been announced just days in advance, with panelists selected behind closed doors.

“That doesn’t necessarily mean it’s wrong, it’s just more a question of what the intent of these meetings are, and how the information gained from these meetings [is] going to be used,” she told MedPage Today.

An HHS spokesperson told MedPage Today that these expert panels “are roundtable discussions with diverse panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and individual experts may offer their recommendations for regulatory action.”

[….]

 

A Less Transparent Process?

Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, D.C., also attended the menopause expert panel, even though it was announced just days in advance.

“If people aren’t being given enough notice to attend, that’s a real problem,” she told MedPage Today.

The panel had a limited number of slots for in-person attendees, so many people who would have attended could not. Yet the room was full of supporters of the panelists, including some of their patients. Zuckerman suspected that some people were alerted to the meeting before others, though an FDA spokesperson did not answer MedPage Today’s question on whether that was the case.

Earlier in the day of the expert panel, Zuckerman was already at FDA in an advisory committee meeting hosted in a large room that ended before the expert panel, meaning there could have been space to host the menopause panel in a room with the capacity for anyone who wished to attend.

“It felt like they only wanted invited guests there in the same way that the panel was all invited to have a particular point of view,” Zuckerman said. “When you have a meeting where everybody’s selected to have a consistent point of view with each other and presumably with the commissioner, and nobody from the public is allowed to say a word, and most people from the public aren’t even allowed to be in the room, that’s … not the transparency that this FDA promised.”

The HHS spokesperson said the “fact that our rooms are filling up for the expert panels proves just how successful they are,” adding that the events are livestreamed for anyone to watch.

 

The spokesperson did not answer MedPage Today‘s specific questions about upcoming expert panels, if everyone is invited to attend the panel at the same time, or why the public is not permitted to speak.

Susan Mayne, PhD, a former director of the FDA’s Center for Food Safety and Applied Nutrition — who has served in three different administrations, including the first Trump term — and said she’s never seen FDA veer from established processes like this before.

For instance, Mayne, who regulated talc in cosmetics during her tenure at FDA, knew that one of the panelists at the talc meeting, Daniel William Cramer, MD, ScD, had been a paid expert witness in litigation against manufacturers who used talc in their products — a significant conflict of interest that wasn’t disclosed at the panel.

[….]

Zuckerman, who was in the room, noted that several panelists mentioned other ways they would financially benefit from the boxed warning being removed from hormone therapy labels — like having more business at their practice — that weren’t included in their disclosures.

[….]

By hosting these panels without following established FDA processes, Makary is acting “like a spokesperson rather than a commissioner,” Zuckerman said.

F.D.A. Panel to Reassess Hormone Therapy Warnings

In the News, We're In the News

Roni Caryn Rabin, New York Times, July 17, 2025

Dr. Marty Makary, commissioner of the Food and Drug Administration, has convened an expert panel on Thursday that he said will “set the record straight” about hormone therapy for menopause, a treatment that he champions despite mixed findings about its risks and benefits.

Although there is no public agenda, the panel is discussing whether the risks have been overstated, deterring women who might benefit.

All menopause treatments containing the hormone estrogen carry a black box warning that the medication should not be used to prevent cardiovascular disease or dementia, and that it increases the risk of strokes, blood clots and probable dementia.

The label also warns of the possibility of breast cancer.

But proponents like Dr. Makary say there’s evidence that hormone therapy — approved for the treatment of symptoms like hot flashes — may prevent cognitive decline, heart disease and some cancers, in addition to conferring benefits that are not in dispute, like reducing osteoporosis-related fractures.

Hormone therapy for menopause has become the focus of intense debate among women. Many argue that a landmark trial may have exaggerated its harms, dissuading physicians from prescribing the treatment and leaving patients without relief from troublesome menopausal symptoms.

Other advocates for women’s health contend there are risks to long-term use that now are being minimized.

Dr. Makary has dismissed findings of a heightened risk of breast cancer in women who took combined estrogen and progestin, saying the research caused a “breast cancer scare” that has deterred women from getting a useful treatment.

“There’s probably no medication that improves the health outcomes of a population more than hormone replacement therapy for women who start it within 10 years of the onset of menopause,” except perhaps antibiotics, Dr. Makary said on a podcast.

“Women live longer, feel better. The benefits are overwhelming.”

[….]

Earlier this week, an editorial in the journal American Family Physician reviewed what it called the “limited benefits” and “significant harms” of hormone therapy, and said potentially fatal outcomes like strokes and breast cancer were being trivialized.

Critics of the panel noted that its 12 members include many physicians who generally agree with Dr. Makary, and that the forum provides no opportunity for public comment.

“This is not like any other public meeting held by the F.D.A. in the past,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank in Washington. “No one in the audience is being allowed to speak. No one can ask questions.”

She expressed concern that most of the panelists have positive views of hormone therapy and that some may have financial conflicts of interest because they run exclusive practices that treat menopause with hormones.

Four panelists are members of Let’s Talk Menopause, an advocacy group supported by Pfizer, Bayer and other pharmaceutical companies that has called for removing the black box warning from local vaginal estrogen products used to treat dryness and sexual symptoms.

A fifth runs a concierge practice specializing in menopause that charges $1,450 for a first appointment. (Dr. Heather Hirsch says on her website that she takes a “no bullshit approach” to menopause.)

Several other panelists do not accept insurance. One, Dr. Kelly Casperson, sells a $48 monthly “program membership” for adults “ready to take back their bodies, intimacy, confidence and life.”

[….]

Also on the panel is Dr. JoAnn E. Manson, a professor at Harvard Medical School who was a lead investigator of the largest randomized controlled clinical trial of hormone therapy for menopause, the Women’s Health Initiative. She is attending remotely.

In an interview, Dr. Manson said that the F.D.A. might be interested in re-evaluating the black box warnings, but noted that there are “major differences” between hormone pills and a product that delivers low doses vaginally for relief of dryness or to prevent urinary tract infections.

Observational studies suggest benefits and few risks associated with the low-dose and locally delivered hormones, but the boxed warning may discourage women from getting relief with them, she said.

[….]

Treatment should be individualized, Dr. Manson said. Oral estrogen alone may lower the risk of breast cancer, but it should be taken only by women who have undergone hysterectomies because it can cause uterine cancer.

Both estrogen alone and combined estrogen and progestin increased the risk of strokes in the W.H.I.

The Women’s Health Initiative, the rigorous trial Dr. Manson worked on, was created because observational studies had linked hormone therapy to long-term health benefits for women. But the branch of the trial studying combined estrogen and progesterone was halted abruptly in 2002 because of signs of an increase in breast cancer and overall health risks.

Still, the danger to individual women was very small, especially among women in early menopause.

Two years later, the branch studying menopausal women taking estrogen alone was halted a year early because participants were at increased risk of stroke.

There was no increase in breast cancer with estrogen alone, and the hormone lowered heart attack risk in women in their 50s, Dr. Manson said. But a related study suggested estrogen alone or with a progestin might raise the odds of cognitive impairment and dementia when started after age 65.

[….]

New hormone formulations have also come on the market since then. Some physicians believe the these products are safer, but they were not tested in the W.H.I. because they were not widely in use at the time.

Conjugated estrogen and combined estrogen and progestin taken orally were tested because “those were the most common formulations that were being used when the W.H.I. was designed in the early 1990s, and those were the formulations that were showing many benefits in the observational studies,” Dr. Manson said.

To read the entire article, click here

NCHR Testimony FDA Advisory Committee on Oncological Drugs on Benrep for Multiple Myeloma

Policy, Testimony & Briefings

July 17, 2025

I’m Dr. Diana Zuckerman, president of the National Center for Health Research. Thank you for the opportunity to share my views today.

The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on the safety and effectiveness of medical products. We do not accept funding from companies that make products that are the subject of our work and therefore have no conflicts of interest.

My perspective is as a cancer survivor who in trained in epidemiology and public health and held research positions at Yale and Harvard before coming to DC to work in the US Congress, HHS, White House, and as the president of a research center. On a personal and professional level, I understand the importance of the FDA and this Committee and I thank you for your service.

In order to consider whether the benefits outweigh the risks of Blenrep, it’s important to ask who was studied in the research you’re considering today.

  • Fewer than 5% were U.S. patients (and why so few?) Thank you to Dr. Pazdur
    for his comments on that issue today.
  • 5% were Black in one study, and none in the other. More important than the
    percentage, there were only 12 Black patients, and that is much too few to
    generalize whether the drug is safe or effective for them. The number of Asian
    and Hispanic patients were also too small to conduct subgroup analyses or to
    generalize.
  • Patients over 75 were also under-represented: 15% & 12% in the two studies.
    That is fewer than half of the percentage that is typical for this disease.

Under these circumstances, would the treatment be approved for Whites only, or not
approved for Blacks? Nobody would want to do that.

There are other flaws in the studies

  • The Comparator arm in DREAMM-8 is not an approved regimen in the U.S.
  • We agree with the FDA that there are other, better treatment options for
    multiple myeloma. And half the patients had only one previous treatment, and
    those were not the most popular treatments available, which again indicates
    that these patients are not generalizable to patients in the U.S.
  • Many patients lowered dosage due to poor tolerability of selected dosages – so
    how can FDA approve an indication based on those dosages?

I’ve attended hundreds of FDA Advisory Committee meetings and I’ve never seen such
a serious side effect as ocular toxicity that affects most patients. As the FDA pointed
out, even blurred vision can be debilitating and risky. Unfortunately, we did not hear
from patients who were harmed by that adverse event.

  • Ocular Toxicity is unique and serious
  • May be asymptomatic at first, which means it can be more harmful because when it is finally diagnosed, it may not be reversible
  • In real world, toxicity monitoring will not be as careful as in a clinical trial. And the rural patients who might most benefit from this treatment option would be the ones least likely to have access to careful monitoring by an ophthalmologist.

In conclusion, Blenrep has benefits, but are they enough to outweigh risks?

  • The primary endpoint of progression free survival was met – but that is compared
    to an unapproved treatment in DREAMM-8 and not compared to optimal
    treatments in DREAMM-7. Since the unapproved treatment is not available,
    we’re left with basically just one study indicating a benefit, not two.
  • Given the very clear risks, the small number of U.S. patients, the under-
    representation of Blacks and older patients, and the availability of other effective
    treatment options, what should patients be told of this drug? Can Black patients
    or patients over 75 be adequately informed of the benefits and risks of this
    treatment for them if this treatment is approved?

FDA Panel to Revisit Menopausal Hormone Therapy

Uncategorized, We're In the News

DAVID LIM and LAUREN GARDNER, Politico;  July 15, 2025

MENOPAUSAL THERAPY IN FOCUS 

The FDA will hold a panel discussion Thursday on hormone therapy for menopausal women, a pet issue for Commissioner Marty Makary that’s separately garnered attention in the states and on social media.

The agency’s X post announcing the event billed it as a forum to “discuss treatments, education, and comprehensive care beyond symptom management.” In a video posted Monday afternoon, Makary said the meeting would “address the evidence and medical dogma in this field.”

Background: An NIH-backed clinical trial of hormone therapy’s benefits and risks to prevent chronic diseases like heart disease was halted in 2002 after investigators said the risks of breast cancer, blood clots and stroke outweighed its symptom-relief properties.

[….]

Makary focused a chapter of his 2024 book “Blind Spots” on the controversy, blasting the study’s administrators for misinterpreting the data. He touted recent studies suggesting hormone therapy could cut risks for heart attacks and cognitive decline “better than billion-dollar drugs.”

The asks: The slate of panel speakers that HHS shared with POLITICO features some doctors whom Makary namechecked in his book — and at least two researchers whose analyses of WHI data have supported its safety in younger women closer to perimenopause onset who don’t have underlying risks for heart disease or breast cancer.

It also includes doctors who promote hormone therapy for menopause. At least three speakers serve as medical advisers to a group petitioning the FDA to remove the boxed warning from the label for vaginal estrogen products, arguing that it improperly deters providers and patients from using them. Dr. Janet Woodcock, the agency’s former top drug regulator, rejected a similar petition in 2018, finding that any label changes should be supported by “well-controlled studies.”

[….]

The caution: Diana Zuckerman, president of the National Center for Health Research, disagrees with criticism of the label, arguing it’s “very balanced” because it encourages providers to prescribe the lowest possible dose that works for as short a time as possible.

“That’s good advice for pretty much any pharmaceutical” besides antibiotics, she added.

The process: Zuckerman also expressed concern about the “expert panel” approach Makary has taken since becoming commissioner, especially given Makary’s promotion of hormones’ benefits in his book. The event lacks an open public comment opportunity, and the agency had yet to publicly post the speaker list Monday evening despite sharing it with POLITICO.

“It’s a very one-sided presentation, and interestingly, he criticizes NIH for their study — for being one-sided on how they presented — and he’s really equally one-sided on the opposite side,” Zuckerman said.

To read the entire article, click here  FDA panel to revisit menopausal hormone therapy – POLITICO

GDUFA IV Statement of Dr. Diana Zuckerman, President of CPTF

Policy, Testimony & Briefings

July 11, 2025

I’m Dr. Diana Zuckerman, president of the National Center for Health Research.  I appreciate the opportunity to speak today.

My perspective is based on my 35 years of working on issues pertaining to the safety and effectiveness of medical products. I have post-doctoral training in epidemiology and public health, and was a faculty member and researcher at Vassar, Yale, and Harvard before moving to Washington to work as a Congressional investigator on FDA issues in the U.S. Congress. Prior to my current position, I also worked at HHS and the White House. Our research center is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products or have any financial interest in our work.

I am one of the FDA’s biggest fans, because I fully appreciate the agency’s importance.  As a founding Board member of the Alliance for a Stronger FDA, I work with nonprofits and industry to increase appropriations for the FDA. We all know that our healthcare system relies on generic drugs and frankly would collapse without them. I wish appropriations would be sufficient to support all of FDA’s essential work, but we know that the FDA needs user fees to ensure getting safe and effective medical products to market in a timely manner. However, speed is not the most important part of that equation.

There have been many inspiring statements in the FDA this year about transparency and about the need for the FDA to regulate industry, rather than be influenced by unduly cozy relationships with industry. An important first step would be for user fee negotiations to include patient, consumer, and public health advocates, instead of only industry and the FDA negotiating behind closed doors. Unfortunately, all user fee negotiations have focused on what industry wants and needs and what they are willing to pay for, and not on what patients and consumers want and need.

On a personal note, my life has depended on generic drugs, which I’ve taken for cancer treatment and for high blood pressure. Like most patients, we trust that generic medications work but we don’t always know for sure. We all depend on generic drugs and understand their importance, so all of us in this room are in this together, and we need to work together.

Trust in generic drugs is essential to help to make healthcare more affordable. Trust in the FDA and in generic drugs has eroded in recent years, and that’s why GDUFA needs to explicitly show that user fees will focus on ensuring that generic drugs are truly equivalent to brand name treatments in all the ways that matter to patients. Speed should be secondary, because when patients realize that some generic drugs are ineffective or unsafe, it harms patients but also harms companies whose products are safe and effective.

Let’s talk about Performance Goals in GDUFA. Up until now, too few have been focused on safety or effectiveness. We are glad that metrics have included the number of inspections and timeliness of inspections and follow-up warning letters, import alerts, and regulatory meetings, and those metrics should included. However, they are not sufficient.

Last summer, the FDA determined that Synapse (a company in India) “faked and forged” data submitted to the FDA. FDA withdrew the bioequivalency rating of 400 of their drugs, but they are still on the market. Neither patients nor pharmacists have access to the names of those drugs. Why is that? That is terribly unfair to patients, but it is also unfair to companies whose safe and effective generic medications are competing with those 400 drugs. And it is also unfair to generic companies that make excellent medications when patients don’t know which generic drugs they can trust.

Valisure has also conducted research showing a sizable number of generic drugs are substandard, with doses that are too high, too low, or drugs that are contaminated or have other problems.

These are just some examples of why post-market surveillance, inspections, and re-inspections are so important and why GDUFA should include funding for those purposes and include those types of metrics in the Commitment Letter.

GDUFA should include metrics showing that these problems are being addressed and generic drugs are truly safe and equivalent to brand name drugs. That’s the promise that GDUFA and the FDA have made to patients and it needs to be kept.

Here is an important list of the kinds of metrics that are missing from previous GDUFA Commitment Letters and should be included in FDA monitoring under GDUFA IV. They are the exact same list that the FDA states are criteria for all generic drugs. They must be:

• Pharmaceutically equivalent
• Capable of making the drug correctly
• Capable of making the drug consistently
• The active ingredient is the same as the name brand and the
same amount gets in the body
• Inactive ingredients are safe
• Drug does not break down over time

We’ve heard about the progress that has been made at the FDA thanks to GDUFA. That progress is wonderful, but to regain trust, improvements should be measurable and included as metrics in GDUFA IV.

Thank you for the opportunity to share my views with you today.

MIT Technology Review

Uncategorized

Meet Jim O’Neill, the longevity enthusiast who is now RFK Jr.’s right-hand man

By Jessica Hamzelou, July 1, 2025

June 30, 2025

When Jim O’Neill was nominated to be the second in command at the US Department of Health and Human Services, Dylan Livingston was excited. As founder and CEO of the lobbying group Alliance for Longevity Initiatives (A4LI), Livingston is a member of a community that seeks to extend human lifespan. O’Neill is “kind of one of us,” he told me shortly before O’Neill was sworn in as deputy secretary on June 9. “And now [he’s] in a position of great influence.”

As Robert F. Kennedy Jr.’s new right-hand man, O’Neill is expected to wield authority at health agencies that fund biomedical research and oversee the regulation of new drugs. And while O’Neill doesn’t subscribe to Kennedy’s most contentious beliefs—and supports existing vaccine schedules—he may still steer the agencies in controversial new directions.

Although much less of a public figure than his new boss, O’Neill is quite well-known in the increasingly well-funded and tight-knit longevity community. His acquaintances include the prominent longevity influencer Bryan Johnson, who describes him as “a soft-spoken, thoughtful, methodical guy,” and the billionaire tech entrepreneur Peter Thiel.

In speaking with more than 20 people who work in the longevity field and are familiar with O’Neill, it’s clear that they share a genuine optimism about his leadership. And while no one can predict exactly what O’Neill will do, many in the community believe that he could help bring attention and resources to their cause and make it easier for them to experiment with potential anti-aging drugs.

This idea is bolstered not just by his personal and professional relationships but also by his past statements and history working at aging-focused organizations—all of which suggest he indeed believes scientists should be working on ways to extend human lifespan beyond its current limits and thinks unproven therapies should be easier to access. He has also supported the libertarian idea of creating new geographic zones, possibly at sea, in which residents can live by their own rules (including, notably, permissive regulatory regimes for new drugs and therapies).

[….]

Not everyone working in health is as enthusiastic, particularly when it comes to any potential changes to drug testing and approvals. If O’Neill still holds the views he has espoused over the years, that’s “worrisome,” says Diana Zuckerman, a health policy analyst and president of the National Center for Health Research, a nonprofit think tank in Washington, DC. 

“There’s nothing worse than getting a bunch of [early-stage unproven therapies] on the market,” she says. Those products might be dangerous and could make people sick while enriching those who develop or sell them. 

“Getting things on the market quickly means that everybody becomes a guinea pig,” Zuckerman says. “That’s not the way those of us who care about health care think.” 

The consumer advocacy group Public Citizen puts it far more bluntly, describing O’Neill as “one of Trump’s worst picks” and saying that he is “unfit to be the #2 US health-care leader.” His libertarian views are “antithetical to basic public health,” the organization’s co-president said in a statement. Neither O’Neill nor HHS responded to requests for comment.

“One of us”

As deputy secretary of HHS, O’Neill will oversee a number of agencies, including the National Institutes of Health, the world’s biggest funder of biomedical research; the Centers for Disease Control and Prevention, the country’s public health agency; and the Food and Drug Administration, which was created to ensure that drugs and medical devices are safe and effective.

“It can be a quite powerful position,” says Patricia Zettler, a legal scholar at Ohio State University who specializes in drug regulation and the FDA.

It is the most senior role O’Neill has held at HHS, though it’s not the first. He occupied various positions in the department over five years during the early 2000s, according to his LinkedIn profile. But it is what he did after that has helped him cultivate a reputation as an ally for longevity enthusiasts.

O’Neill appears to have had a close relationship with Thiel since at least the late 2000s. Thiel has heavily invested in longevity research and has said he does not believe that death is inevitable. In 2011 O’Neill referred to Thiel as his “friend and patron.” (A representative for Thiel did not respond to a request for comment.)

O’Neill also served as CEO of the Thiel Foundation between 2009 and 2012 and cofounded the Thiel Fellowship, which offers $200,000 to promising young people if they drop out of college and do other work. And he spent seven years as managing director of Mithril Capital Management, a “family of long-term venture capital funds” founded by Thiel, according to O’Neill’s LinkedIn profile.

O’Neill got further stitched into the longevity field when he spent more than a decade representing Thiel’s interests as a board member of the SENS Research Foundation (SRF), an organization dedicated to finding treatments for aging, to which Thiel was a significant donor.

[….]

Longevity science is a field that’s long courted controversy, owing largely to far-fetched promises of immortality and the ongoing marketing of creams, pills, intravenous infusions, and other so-called anti-aging treatments that are not supported by evidence. But the community includes people along a spectrum of beliefs (with the goals of adding a few years of healthy lifespan to the population at one end and immortality at the other), and serious doctors and scientists are working to bring legitimacy to the field.

Pretty much everyone in the field that I spoke with appears to be hopeful about what O’Neill will do now that he’s been confirmed. Namely, they hope he will use his new position to direct attention and funds to legitimate longevity research and the development of new drugs that might slow or reverse human aging.

[….]

Changing the rules

While plenty of treatments have been shown to slow aging in lab animals, none of them have been found to successfully slow or reverse human aging. And many longevity enthusiasts believe drug regulations are to blame.

O’Neill is one of them. He has long supported deregulation of new drugs and medical devices. During his first tour at HHS, for instance, he pushed back against regulations on the use of algorithms in medical devices. “FDA had to argue that an algorithm … is a medical device,” he said in a 2014 presentation at a meeting on “rejuvenation biotechnology.” “I managed to put a stop to that, at least while I was there.”

During the same presentation, O’Neill advocated lowering the bar for drug approvals in the US. “We should reform [the] FDA so that it is approving drugs after their sponsors have demonstrated safety and let people start using them at their own risk,” he said. “Let’s prove efficacy after they’ve been legalized.”

This sentiment appears to be shared by Robert F. Kennedy Jr. In a recent podcast interview with Gary Brecka, who describes himself as a “longevity expert,” Kennedy said that he wanted to expand access to experimental therapies. “If you want to take an experimental drug … you ought to be able to do that,” he said in the episode, which was published online in May.

But the idea is divisive. O’Neill was essentially suggesting that drugs be made available after the very first stage of clinical testing, which is designed to test whether a new treatment is safe. These tests are typically small and don’t reveal whether the drug actually works.

That’s an idea that concerns ethicists. “It’s just absurd to think that the regulatory agency that’s responsible for making sure that products are safe and effective before they’re made available to patients couldn’t protect patients from charlatans,” says Holly Fernandez Lynch, a professor of medical ethics and health policy at the University of Pennsylvania who is currently on sabbatical. “It’s just like a complete dereliction of duty.”

[….]

Ultimately, though, even if O’Neill does try to change things, Zettler points out that there is currently no lawful way for the FDA to approve drugs that aren’t shown to be effective. That requirement won’t change unless Congress acts on the matter, she says: “It remains to be seen how big of a role HHS leadership will have in FDA policy on that front.”

A longevity state

A major goal for a subset of longevity enthusiasts relates to another controversial idea: creating new geographic zones in which people can live by their own rules. The goal has taken various forms, including “network states” (which could start out as online social networks and evolve into territories that make use of cryptocurrency), “special economic zones,” and more recently “freedom cities.”

While specific details vary, the fundamental concept is creating a new society, beyond the limits of nations and governments, as a place to experiment with new approaches to rules and regulations.

In 2023, for instance, a group of longevity enthusiasts met at a temporary “pop-up city” in Montenegro to discuss plans to establish a “longevity state”—a geographic zone with a focus on extending human lifespan. Such a zone might encourage healthy behaviors and longevity research, as well as a fast-tracked system to approve promising-looking longevity drugs. They considered Rhode Island as the site but later changed their minds.

Some of those same longevity enthusiasts have set up shop in Próspera, Honduras—a “special economic zone” on the island of Roatán with a libertarian approach to governance, where residents are able to make their own suggestions for medical regulations. Another pop-up city, Vitalia, was set up there for two months in 2024, complete with its own biohacking lab; it also happened to be in close proximity to an established clinic selling an unproven longevity “gene therapy” for around $20,000. The people behind Vitalia referred to it as “a Los Alamos for longevity.” Another new project, Infinita City, is now underway in the former Vitalia location.

O’Neill has voiced support for this broad concept, too. He’s posted on X about his support for limiting the role of government, writing “Get government out of the way” and, in reference to bills to shrink what some politicians see as government overreach, “No reason to wait.” And more to the point, he wrote on X last November, “Build freedom cities,” reposting another message that said: “I love the idea and think we should put the first one on the former Alameda Naval Air Station on the San Francisco Bay.”

And up until March of last year, according to his financial disclosures, he served on the board of directors of the Seasteading Institute, an organization with the goal of creating “startup countries” at sea. “We are also negotiating with countries to establish a SeaZone (a specially designed economic zone where seasteading companies could build their platforms),” the organization explains on its website.

“The healthiest societies in 2030 will most likely be on the sea,” O’Neill told an audience at a Seasteading Institute conference in 2009. In that presentation, he talked up the benefits of a free market for health care, saying that seasteads could offer improved health care and serve as medical tourism hubs: “The last best hope for freedom is on the sea.”

Some in the longevity community see the ultimate goal as establishing a network state within the US. “That’s essentially what we’re doing in Montana,” says A4LI’s Livingston, referring to his successful lobbying efforts to create a hub for experimental medicine there. Over the last couple of years, the state has expanded Right to Try laws, which were originally designed to allow terminally ill individuals to access unproven treatments. Under new state laws, anyone can access such treatments, providing they have been through an initial phase I trial as a preliminary safety test.

“We’re doing a freedom city in Montana without calling it a freedom city,” says Livingston.

Patri Friedman, the libertarian founder of the Seasteading Institute, who calls O’Neill “a close friend,” explains that part of the idea of freedom cities is to create “specific industry clusters” on federal land in the US and win “regulatory carve-outs” that benefit those industries.

A freedom city for longevity biotech is “being discussed,” says Friedman, although he adds that those discussions are still in the very early stages. He says he’d possibly work with O’Neill on “changing regulations that are under HHS” but isn’t yet certain what that might involve: “We’re still trying to research and define the whole program and gather support for it.”

Will he deliver?

Some libertarians, including longevity enthusiasts, believe this is their moment to build a new experimental home.

Not only do they expect backing from O’Neill, but they believe President Trump has advocated for new economic zones, perhaps dedicated to the support of specific industries, that can set their own rules for governance.

[….]

“The notion around so-called freedom cities, with respect to biomedical innovation, just reflects deep misunderstandings of what drug development entails,” says Ohio State’s Zettler. “It’s not regulatory requirements that [slow down] drug development—it’s the scientific difficulty of assessing safety and effectiveness and of finding true therapies.”

Making matters even murkier, a lot of the research geared toward finding those therapies has been subject to drastic cuts.The NIH is the largest funder of biomedical research in the world and has supported major scientific discoveries, including those that benefit longevity research. But in late March, HHS announced a “dramatic restructuring” that would involve laying off 10,000 full-time employees. Since Trump took office, over a thousand NIH research grants have been ended and the administration has announced plans to slash funding for “indirect” research costs—a move that would cost individual research institutions millions of dollars. Research universities (notably Harvard) have been the target of policies to limit or revoke visas for international students, demands to change curricula, and threats to their funding and tax-exempt status.

The NIH also directly supports aging research. Notably, the Interventions Testing Program is a program run by the National Institutes of Aging (a branch of the NIH) to find drugs that make mice live longer. The idea is to understand the biology of aging and find candidates for human longevity drugs.

The ITP has tested around five to seven drugs a year for over 20 years, says Richard Miller, a professor of pathology at the University of Michigan, one of three institutes involved in the program. “We’ve published eight winners so far,” he adds.

The future of the ITP is uncertain, given recent actions of the Trump administration, he says. The cap on indirect costs alone would cost the University of Michigan around $181 million, the university’s interim vice president for research and innovation said in February. The proposals are subject to ongoing legal battles. But in the meantime, morale is low, says Miller. “In the worst-case scenario, all aging research [would be stopped],” he says.

The A4LI has also had to tailor its lobbying strategy given the current administration’s position on government-funded research. Alongside its efforts to change Montana state law to allow clinics to sell unproven treatments, the organization had been planning to push for an all-new NIH institute dedicated to aging and longevity research—an idea that O’Neill voiced support for last year. But current funding cuts under the new administration suggest that it’s “not the ideal political climate for this,” says Livingston.

Despite their enthusiasm for O’Neill’s confirmation, this has all left many members of the longevity community, particularly those with research backgrounds, concerned about what the cuts mean for the future of longevity science.

“Someone like [O’Neill], who’s an advocate for aging and longevity, would be fantastic to have at HHS,” says Matthew O’Connor, who spent over a decade at SRF and says he knows O’Neill “pretty well.” But he adds that “we shouldn’t be cutting the NIH.” Instead, he argues, the agency’s funding should be multiplied by 10.

“The solution to curing diseases isn’t to get rid of the organizations that are there to help us cure diseases,” adds O’Connor, who is currently co-CEO at Cyclarity Therapeutics, a company developing drugs for atherosclerosis and other age-related diseases.

[….]

RFK Jr.’s Planned Assault on Corporate Influence Is Clashing With Reality

In the News, News Stories & Editorials, We're In the News

Margaret Manto, NOTUS, June 26, 2025

Health Secretary Robert F. Kennedy Jr. has made ending “corporate capture” of the federal health agencies a key tenet of his plan to eradicate what the MAHA Commission Assessment describes as “threats to American childhood that have been exacerbated by perverse incentives.”

But health care lobbyists, regulatory experts and advocates for reduced industry involvement all told NOTUS the same thing: So far, Kennedy’s words don’t match his actions.

“The rhetoric is quite different, but it doesn’t seem like the reality is obviously different,” said Diana Zuckerman, president of the National Center for Health Research, who has criticized the Food and Drug Administration’s funding structure that relies on collecting fees from the companies whose products it regulates. “There’s all kinds of conflicts of interest that have been absolutely ignored by HHS and, as far as we can tell, still are.”

Since ascending to the top of the U.S. public health system, Kennedy has made grand gestures towards his supposed goal of clamping down on corporate influence at the Department of Health and Human Services. He’s held press conferences to tout agreements made with food producers to end the use of certain synthetic food dyes and with insurance companies to speed up the prior authorization process, both of which companies have lobbied against for years.

But these agreements have all been entirely voluntary. In the case of the food dye announcement, that was a direct result of industry influence, said one lobbyist granted anonymity to speak frankly.

“Their biggest win was not real,” the lobbyist said.

[….]

“Secretary Kennedy’s commitment to eliminating undue corporate influence and restoring public trust in health policy is backed by decisive action. Under the Secretary’s leadership, HHS has taken concrete steps to increase transparency, strengthen ethical standards, and prioritize the health and well-being of the American people over industry profits,” the spokesperson wrote.

But the MAHA report, which took aim at a range of public health interventions that the MAHA movement is suspicious of, including vaccines and ultraprocessed foods, was noticeably light on criticism of the agriculture industry and pesticide use — which Kennedy has pledged to reform.

In a hearing last month before a subcommittee of the Senate Committee on Appropriations, Kennedy assured senators that he would “not do anything to jeopardize that business model.”

Other than reworking their pitches to use new, more MAHA-friendly language, companies and the lobbyists who work for them haven’t had to do much to adapt to the new HHS leadership, the lobbyist said.

“I haven’t noticed anything different at all,” they said. “I don’t know anybody who’s had a problem getting a meeting.”

[….]

Since these meetings, HHS has embarked on policies that both advance the MAHA movement’s public health goals and provide potential benefits to industries deemed acceptable.

Earlier this month, STAT News reported that HHS put out a call for proposals for a “bold, edgy” public messaging campaign to “inspire and empower Americans to reclaim control over their health.” The request specifically asks for proposals that highlight health wearables as “cool, modern tools.”

“My vision is that every American is wearing a wearable within four years,” Kennedy said during a congressional hearing this week.

Other policy decisions seem poised to benefit not just certain niches of the health care industry, but key players within the MAHA movement. In early June, the Food and Drug Administration declined to contest a court ruling that overturned a 2024 FDA rule regulating laboratory-developed tests.

The agency had previously argued that increased regulation was necessary to “better protect the public health by helping to assure the safety and effectiveness” of tests that are manufactured and used by a single laboratory, as opposed to commercially available in-vitro diagnostics that are used by labs nationwide and which the FDA requires to be thoroughly verified and validated.

[….]

The FDA is the main arbiter of which drugs, medical devices and food additives are allowed to enter the U.S. market. It has long borne the brunt of Kennedy’s and other HHS critics’ “corporate capture” accusations thanks to its user-fee funding structure, where companies pay to have their products reviewed by the FDA and help supplement the agency’s congressionally allocated funds.

Corporate influence watchdogs are scrutinizing other recent FDA shifts, too.

While FDA commissioner Marty Makary promised “radical transparency” during his confirmation process, earlier this month he announced a nationwide “listening tour” where he will meet with pharmaceutical and biotech CEOs to solicit their input on “how the FDA can modernize its regulatory framework to better support innovation and patient access to safe and effective therapies.”

Companies are required to have an active drug or device application with the FDA in order to send a representative to meet with Makary.

“The listening tours usually actually involve listening to the public, not just listening to each other,” said Zuckerman. “In the past they’d have it at some university or medical center or something, a public meeting. Anybody could sign up to attend, anybody could sign up to ask questions or make comments.”

The HHS spokesperson said the listening tour is intended to “break through the bureaucratic echo chambers that have long hindered the FDA” and that “direct engagement with regulated industry is essential for real reform and accountability.”

Makary also recently announced a new “Commissioner’s National Priority Voucher” program that would speed up the FDA review process for companies whose products “enhance the health interests of Americans.”

Reshma Ramachandran, a professor of medicine at Yale University who studies the influence of pharmaceutical companies, said the new voucher would likely worsen the existing conflict of interest issues at the FDA. She pointed to the shorter review time and deep personnel cuts at the agency as issues that would increase the FDA’s reliance on what the companies themselves say about their products.

“Will FDA have enough capacity to even push back against companies?” Ramachandran said.

HHS’ spokesperson disputed this characterization, saying that the National Priority Review Voucher program is about urgency, not favoritism.

“Expediting reviews for high-impact products does not compromise scientific integrity — it enhances timely access to innovations that can save lives,” they wrote.

One industry expert said he felt that both could be true at the same time.

“The National Priorities Voucher initiative at FDA goes right to the top of my lists of things that make you go ‘hmmm,’” said Steve Grossman, a regulatory consultant and co-founder of the Alliance for a Stronger FDA. “I like the boldness in thinking about FDA’s contribution to public health, the clear commitment to quicker decisions by the agency and the good sense of starting with a pilot program. At the same time, I worry about diluting the focus on unmet medical needs, the subjectivity of who receives the vouchers and the potential manpower crunch.”

Makary also announced earlier this year that the FDA would limit industry representation on FDA committees to what was “statutorily allowed” — something that Zuckerman said has been “pretty much true for years.”

While changes to committee membership may get plenty of attention, “there’s a much bigger universe of ways in which industry interfaces with HHS and all its subsidiary agencies,” said Matthew McCoy, an assistant professor of Medical Ethics and Health Policy at the University of Pennsylvania who studies conflicts of interest.

“It’s not as if that’s the only way in which industry influences can shape the way that policy making happens within these health care agencies,” said McCoy.

—
Margaret Manto is a NOTUS reporter and an Allbritton Journalism Institute fellow.

CORRECTION: An earlier version of this story misstated Steve Grossman’s title. He is a regulatory consultant and co-founder of the Alliance for a Stronger FDA.