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Testimony of Dr. Akashleena Mallick at the FDA TPSAC Meeting on ZYN Nicotine Pouch Products Submitted by Swedish Match U.S.A, Inc.

Testimony & Briefings

January 22, 2026

I am Dr. Akashleena Mallick. I am a physician and public health researcher with the nonprofit National Center for Health Research.

A modified-risk authorization requires a clear benefit to public health. That standard is not met here. I will explain why.

I want to begin by supporting the concerns previously raised by UCSF and Tobacco Free Kids about the use of nicotine pouches by about half a million U.S. middle and high school students. I will now focus on the medical, pediatric, and public health harms of ZYN.

A modified-risk order requires proof of less disease. The FDA found no data on the health impact of ZYN. Relying on General snus data is inappropriate because these products differ in use, toxicology, and marketing. We agree with the FDA that data on Swedish adults do not apply to U.S. teenagers. That’s why FDA’s General Snus MRTP is not a valid precedent for ZYN.

Claims of reduced risk for cancer, heart disease, and stroke would require decades of follow-up to make them comparable to the risks of cigarettes. No such data exists. Short-term biomarkers and toxicant comparisons cannot prove disease reduction. Nicotine itself harms the heart and blood vessels, as concluded by the American Heart Association and the European Society of Cardiology. Nicotine raises blood pressure and heart rate and worsens vascular function- key pathways for heart attack and stroke. Without long-term data showing fewer cancers, heart attacks, or strokes, any claim of reduced risk is misleading and probably incorrect.

US poison center data show nicotine pouch exposures rose dramatically, from 181 cases in 2022 to over 900 cases by early 2025. Nearly three-quarters of these cases involved children under age five, mostly from accidental ingestion. A peer-reviewed national study found that nicotine pouch ingestions in young children rose more than 760 percent in just three years and were more likely than other nicotine products to cause serious harm or hospital admission. These injuries are happening now.

ZYN has a record of aggressive marketing with a rewards program that encourages more frequent use, including in children and adolescents. If the goal of ZYN was to give a safer alternative to smoking, why is ZYN successfully focusing its marketing on children and teens, most of whom don’t smoke?

Independent research shows that modified-risk claims are often misunderstood as “safe.” Leading to dual use, delayed quitting, and use by non-smokers who then become addicted. Some states apply lower taxes to MRTP products, and companies push for those cuts. Lower prices increase use among both smokers and non-smokers.

The FDA said e-cigarettes would help adults quit. Instead, they helped fuel a youth nicotine epidemic. Nicotine pouch sales have already risen more than 10-fold, from 126 million units in 5 months in 2019 to over 800 million units in 3 months in early 2022.

There is no long-term evidence that ZYN reduces mouth cancer, lung cancer, heart disease, or stroke. But there is clear evidence of pediatric poisonings, likely cardiovascular harm, problematic marketing, and increasing risks to public health.

For these reasons, ZYN nicotine pouches do not meet the legal standard for modified-risk authorization.

Thank you.

Click here to read our written comment to the FDA on the Modified Risk Tobacco Product applications for ZYN nicotine pouch products.

5 topics to watch as MDUFA negotiations restart

Uncategorized

Elise Reuter, MedTech Dive, January 14, 2026

Medtech lobbyists and the Food and Drug Administration’s medical device center began negotiations last year on an agreement that sets a significant portion of the center’s budget. The Medical Device User Fee Amendments, or MDUFA, determine how much the FDA can raise in industry fees over a five-year period, supplementing taxpayer funding.

The FDA and industry must come to an agreement before September 2027, when the current MDUFA agreement is set to expire, although stakeholders expect an agreement to go to Congress this year. Device lobbyists called for a renewal of the current agreement, with a similar funding amount and structure, while patient groups emphasized the need for increased safety and transparency. Many stakeholders also raised concerns about the FDA’s capacity after staff cuts that took place last year.

Here are five topics to watch as the FDA and industry near a deal:

  1. Negotiations are moving quickly

The medtech industry and the FDA meet multiple times per month to hammer out an agreement for MDUFA VI, which must go to Congress for approval before the current program expires in September 2027. Those meetings take place behind closed doors, and sparse meeting minutes provide an indication of where the discussions are headed. Patient and physician groups, and other stakeholders, participate in separate, monthly meetings.

Diana Zuckerman, president of the National Center for Health Research, a nonpartisan think tank, told MedTech Dive that the FDA and industry aim to bring a commitment letter to Congress this year, possibly before the midterm elections this fall. Zuckerman and other stakeholders said an agreement could come as early as the first quarter of 2026.

“They seem to be moving quickly,” Zuckerman said. “They’re happy with the way things are. Industry is happy. FDA is happy.”

Medtech lobbying groups AdvaMed and the Medical Device Manufacturers Association, or MDMA, declined to comment on the negotiations. When asked about the timing and amount of funding the FDA hopes to see in the next agreement, Department of Health and Human Services spokesperson Andrew Nixon pointed to meeting minutes.

In broad summaries of their discussions, the FDA described a need for more resources, while the medtech industry called for similar terms to the current user fee agreement. The current program, MDUFA V, allows the FDA’s Center for Devices and Radiological Health to receive $1.78 billion to $1.9 billion over five years, with the final tally depending on whether the agency meets certain performance and hiring goals.

The MDMA noted a “significant ramp up in user fees under MDUFA V, especially in the last two years of the program,” according to a summary of an Oct. 29 meeting. 

Bottom of Form

In the same discussion, AdvaMed called for the FDA to keep the current MDUFA V framework, adding that the program has reached a “steady state.” The FDA had been considering a simpler fee structure without adjustments for hiring goals and add-on payments for performance.

  1. Patient groups and industry are worried about staff cuts

After the Trump administration slashed the FDA’s workforce last year, industry and patient groups alike have been raising concerns about the impact. While the FDA has never stated how many people were cut, the HHS said last spring that it would cut 3,500 FDA workers, and a ProPublica analysis in August found that the CDRH had lost more than 20% of its staff due to cuts and attrition.

“The FDA clearly has expressed to us, stakeholders outside the industry, that they’re shorthanded,” said Michael Abrams, a senior health researcher at consumer advocacy nonprofit Public Citizen. “They’re feeling stressed for obvious reasons. The FDA has received huge, nondiscriminate [Department of Government Efficiency] cuts.”

In discussions with industry, the FDA’s device center has acknowledged challenges. For the majority of 2025, “staff have been focused solely on review work, which has created some system strain,” the agency said in an Oct. 29 meeting.

[….]

The CDRH committed to “maintaining or achieving appropriate staffing levels” to meet its goals in a Dec. 2 meeting. A week later, industry groups called for confirmation that new hires funded under MDUFA V will be realized by the end of fiscal 2027, according to meeting notes.

Madris Kinard, a former FDA public health analyst and CEO of Device Events, said it may be challenging to hire people, adding that it can take six months to a year to hire at the FDA.

“The people that were let go are in a real bind and may not be willing to go back to something that’s unsure,” Kinard said.

  1. The FDA’s proposals include changes to user fee triggers, higher fees overseas

The FDA proposed changes to “triggers” that determine whether the agency can continue to collect user fees. Currently, there are two triggers intended to ensure that user fees supplement the FDA’s budget rather than replacing congressional funds. Congress must provide a certain level of funding for CDRH, and CDRH must spend a certain amount of non-user-fee funding on device reviews and other costs.

[….]

In the Dec. 2 meeting, the FDA proposed changing the appropriation and budgetary spending thresholds, including increasing both thresholds and the operating reserve to cover extended lapses in funding. Industry representatives said a week later that they were open to discussions on the spending trigger but opposed changing the appropriations trigger.

Another big change proposed by the FDA is to levy more fees from medical device companies overseas than in the U.S.

The agency said the changes would account for the additional resources needed to oversee foreign firms, adding in a Dec. 12 meeting that companies operating within the U.S. may see flat or decreased fees.

  1. Patient groups call for more focus on safety and effectiveness

Patient advocates called for more FDA funding to go toward ensuring devices are safe and effective, rather than emphasizing speed of reviews. Some people, including Public Citizen’s Abrams, called for more funding from Congress to support postmarket reviews and recalls.

Abrams also raised concerns about fast-track programs for medical devices. Last year, the FDA and the Centers for Medicare and Medicaid Services announced a pilot where device makers can ask the agency to waive premarket authorization and investigational device requirements for some digital health products while they collect real-world data.

“[HHS Secretary Robert F. Kennedy Jr.] and [FDA Commissioner Martin Makary] say they want gold standard evidence, but are also calling for lowering standards and fast-track approvals,” Abrams said.

Alexander Naum, policy manager for Generation Patient, a nonprofit representing young adults with chronic health conditions, said he was also worried about fast-track programs, and called for more postmarket monitoring of medical devices. For implants in particular, Naum would like to see reporting requirements to help patients better understand how a medical device is going to age and mature with them.

“We’re just really concerned when that innovation isn’t coming with appropriate safeguards needed to protect patients,” Naum said.

Stakeholders also called for more user-friendly adverse event reporting and more enforcement to ensure device companies report malfunctions, injuries and deaths in a timely fashion. They noted a recent government watchdog report found the FDA needs more staff and authority to oversee medical device recalls.

  1. Without access to industry meetings, public input is limited

Patient groups told MedTech Dive that it was difficult to provide input on the negotiations with industry because they are denied access to those meetings and have to rely on vague minutes to understand what the FDA and device lobbyists are discussing.

During the previous round of user fee negotiations in 2022, the FDA’s device center received criticism from senators after neglecting to post meeting minutes for months. In the current negotiation, minutes are posted weeks after meetings and include few details on the meat of what was discussed.

[….]

This has been a “major barrier” in keeping track of where the FDA and industry are at in negotiations, said Isabella Xu, a policy associate at the Center for Science in the Public Interest.

[….]

Patient advocates also said that sometimes the topics presented by the FDA at stakeholder meetings don’t match what patients care about. The Patient, Consumer and Public Health coalition, a group of more than two dozen nonprofits focusing on medical and consumer products, said in an emailed statement that the scope of the meetings is limited and many of the topics focus on making reviews faster and offering industry more access to FDA staff and expertise. 

“There’s just nothing about issues that a lot of the patient groups really care about,” NCHR’s Zuckerman said. “Yes, patient groups care about access, but they also care about safety and they also care about effectiveness.”

Top drug regulator Richard Pazdur set to leave the FDA

News Stories & Editorials, We're In the News
STAT News
December 2, 2025. Lizzy Lawrence

WASHINGTON — Top drug regulator Richard Pazdur has filed papers to retire from the Food and Drug Administration at the end of this month, adding to the turmoil atop the agency.

Pazdur informed leaders at the FDA’s drug center of his intention to leave the agency at a meeting on Tuesday, according to two agency sources familiar with the matter. The move comes less than a month after he took the role of top drug regulator at the urging of FDA Commissioner Marty Makary.

A spokesperson for the FDA confirmed the news and said Pazdur’s decision is final. Pazdur did not respond to a request for comment.

“We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” the FDA spokesperson told STAT. “As the founding director of the Oncology Center of Excellence, he leaves a legacy of cross-center regulatory innovation that strengthened the agency and advanced care for countless patients.”

Pazdur is the fourth person to lead the Center for Drug Evaluation and Research this year. The previous director, George Tidmarsh, left the agency in November amid allegations that he used his position to advance a personal vendetta against a business associate, and amid conflict with Center for Biologics Evaluation and Research Director Vinay Prasad.

Three sources close to Pazdur told STAT that concerns about the legality of a new drug review program, Makary and Prasad inserting themselves into drug review decisions, and Makary’s efforts to handpick hires for CDER contributed to Pazdur’s decision to leave.

The elevation of Pazdur, a longtime FDA staffer who was previously the director of the cancer center, was intended to stabilize the agency. Biotech stocks gave up gains after STAT reported on Pazdur’s plan, with the S&P Biotech ETF sliding 1%.

“Really bad news here,” John Maraganore, the founder of Alnylam Pharmaceuticals, posted on social media. “Rick Pazdur has been a National Treasure for efforts in bringing safe and effective cancer medicines to patients.”

[….]

Even patient advocates who sometimes disagreed with Pazdur’s decisions to approve certain cancer drugs expressed dismay at the news.

“Dr. Pazdur’s retirement is a huge loss for the FDA and for patients across our country,” said Diana Zuckerman, president of the National Center for Health Research. “Many of us appreciate that he was willing to express his concerns about FDA’s recent plans to speed up the approval process at a time when FDA had lost staff and expertise.”

Pazdur took the job on assurances that he would be protected from political influence, sources close to him previously told STAT. Political pressure has increasingly affected science at the agency, especially for products of particular interest to health secretary Robert F. Kennedy Jr., like vaccines, antidepressants, and autism treatments.

But it seems that Pazdur ran into issues almost immediately. The Washington Post reported that Pazdur raised concerns about a new program spearheaded by Makary to offer expedited review to drugs that align with national priorities. He noted that the program, called the Commissioner’s National Priority Voucher, was not transparent and could be illegal. Tidmarsh also raised concerns about the program on his way out of the FDA.

[….]

Experts told STAT that the personnel drama at the FDA threatens to undermine the credibility of the agency, which is charged with protecting and promoting public health.

To read the entire article, click here 

Menopause and Hormones

Prevention

National Center of Health Research

Lower hormone levels in menopause may lead to hot flashes, trouble sleeping, vaginal dryness, and fragile bones.

What is Hormone Therapy for Menopause?

Like all medicines, hormone therapy has advantages and disadvantages. The evidence about risks and benefits is complicated, and some health professionals are more knowledgeable than others, so it’s important to read articles like this one before you talk to your doctor, nurse, or pharmacist about hormones.

What are the Symptoms of Menopause?

  • Thinning of your bones, Bones become more fragile, which may lead to loss of height, and bones are more likely to break (osteoporosis)

What are the Benefits of Using Hormones for Menopause?

  • Hormone therapy is the most effective FDA-approved medicine for the relief of hot flashes, night sweats, or vaginal dryness.
  • While you are taking hormones, they may reduce your chances of your bones becoming fragile and more likely to break (osteoporosis). However, when you stop taking the hormones, your bones will become more fragile, so it is important to improve your bone health through diet (calcium) and exercise.

What are the Risks of Using Hormones for Menopause?

The risks of oral hormones (pills) for menopause tend to be greater for older women (over 60) than for women in their 50s, but regardless of age, on average, long-term hormone use tends to cause harm that outweighs the benefits. The more you know, the more likely you are to make the decision that is best for you. For example, combined hormone therapy has been found to increase the chances of dementia, while estrogen alone increases the chances of developing ovarian cancer and decreases the chances of developing breast cancer. For a woman with a uterus, taking estrogen alone increases her chances of developing endometrial cancer (cancer of the uterine lining), while adding progestin to estrogen lowers the risk of endometrial cancer.

As you can see, the advantages and disadvantages vary depending on which hormones, your age, and your medical history.

Research on combined estrogen and progestin shows it probably can increase the chances of cognitive impairment (early Alzheimer’s or dementia) in women older than 65.

Will Hormone Therapy Protect the Heart and Prevent Strokes?

The evidence is mixed on heart disease, but hormones seem to increase the risk of strokes.

 

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

The National Center for Health Research is a nonprofit, nonpartisan research, education, and advocacy organization that analyzes and explains the latest medical research and speaks out on policies and programs. We do not accept funding from pharmaceutical companies or medical device manufacturers. Find out how you can support us here. 

The FDA Commissioner Is Missing the Point of Advisory Committees

News Stories & Editorials, We're In the News

Makary’s hand-picked panels lack diversity of opinion, robust evidence reviews, and credibility

by Diana Zuckerman, PhD, November 22, 2025

Zuckerman is the founding president of a nonprofit think tank, and a former Congressional Committee staffer who investigated FDA policies.

The recent controversies about the safety of antidepressants during pregnancy and hormone therapy for menopause were heightened by how decisions are being made. Earlier this month, HHS officials announced that boxed warnings would be removed from hormone therapy drugs to treat symptoms of menopause, several months after a group of 12 experts handpicked by FDA Commissioner Marty Makary, MD, MPH, recommended removal of the warnings.

Makary asserted that traditional FDA advisory committees — which have historically been convened before making such a change — are outdated because they are “bureaucratic, long, often conflicted, and very expensive.” He said he plans to instead rely more on his expert panels, which he described as more “spontaneous” but still “robust.”

There are many differences between advisory committees and the “expert panels” held this year. As someone who has participated in hundreds of FDA advisory committee meetings and watched several of these expert panels, I believe Makary is missing the point and undermining the credibility of FDA decisions.

What Is the Purpose of Advisory Committees?

FDA advisory committee meetings are scheduled for drugs, devices, or tobacco products when there is conflicting evidence or a contentious difference of opinion within the agency or between the agency’s point of view and other interested parties (such as the company that makes the product).

Typically, the meeting focuses on whether a new drug or device merits FDA approval, whether there is persuasive evidence that an approved product is less safe or effective than FDA previously concluded, or if a type of product may require more/less rigorous regulatory standards than currently required.

Most meetings are around 8 hours long (although this varies): approximately 2 hours for the company to provide evidence on safety and efficacy; 1-2 hours for FDA scientists to express their views of the evidence; 1 hour for an “open public hearing” for patients, family members, or health professionals or organizations to express their views; and 3 hours of advisory committee questions, discussion, and voting. A full meeting transcript is made publicly available afterwards and typically the meetings are all livestreamed now as well.

The members typically include about a dozen medical experts (mostly clinicians) who do not work for a federal agency; at least one patient or consumer representative; and one industry representative (non-voting). Many serve on the committee for several years after being nominated and selected based on their medical specialty; at each meeting, a few additional experts are added because of their relevant expertise. FDA staff are not on the committee, but NIH or other agencies may have one or two non-voting members with relevant expertise.

Weeks before the meeting, advisory committee members are provided with the company’s description of their evidence (often 100+ pages long) and the FDA’s detailed critique of that evidence. These documents, the agenda, names and affiliations of committee members, and information about possible conflicts of interest are made publicly available on FDA.gov 48 hours in advance and stay online for years afterwards.

How Are Expert Panels Different?

Compare that to a 2-hour expert panel meeting, comprised of approximately 8 to 12 experts selected by the FDA, each speaking for a few minutes and answering softball questions asked by the FDA commissioner or other official. The list of speakers is not necessarily released in advance (perhaps in part due to the “spontaneous” nature of the panels), no written documentation regarding the evidence has been provided to the public, and the panel members’ presentations appear mostly consistent with the commissioner’s opinion. The public can attend in person or remotely but can’t ask questions or express their views.

One unfortunate trait that the advisory committees and expert panels have in common is that some members are less “expert” than others. Many are clinicians with limited understanding of statistics or the implications of the FDA regulatory process. Meanwhile, the academic physicians participating do not acknowledge that many clinicians who write these prescriptions may rely on drug and device representatives for information rather than regularly reading studies in medical journals or closely studying very long drug labels.

Another unfortunate trait they have in common is conflicts of interest. Financial ties to industry are discouraged but still exist and are not always disclosed. Both panels include clinicians whose quoted statements at these meetings may influence their salaries by generating positive or negative publicity. An additional possible conflict unique to researchers on expert panels is the assumption that pleasing HHS officials could improve their chances of future federal funding or recognition.

Shortcomings of Advisory Committees

To be fair, during advisory committee meetings, some committee members appear to have not read most of the meeting materials provided in advance, and it sometimes seems the FDA has “stacked the deck” by cherry-picking committee members. Also, the votes may at times be unanimous even when numerous members express great concerns about the product. For example, I once heard a committee member share substantial doubts and then say, “I certainly would not want my mother to take it” — but he voted in favor of the product anyway.

In addition to companies’ hours-long presentations, many recruit and train public comment speakers. Most are patients desperate for a cure who may not realize the product performed no better than placebo. Their stories are often tragic and compelling, and numerous advisory committee members have told me they voted in favor of a product of questionable efficacy because they didn’t want to seem indifferent to the patients’ plight.

As President Biden’s FDA commissioner, Robert Califf, MD, openly expressed concerns about FDA advisory committee meetings. In a meeting with several nonprofit leaders, he made it clear to us that he did not like it when FDA was criticized for approving a product that the advisory committee had voted against. At the end of the day, the advisory committees serve as just that: advisors. They have not been a rubber-stamp; although in the future, FDA may try to take them in a different direction. But the value of this public forum for discussion and transparency cannot be overstated.

Don’t Let Perfect Be the Enemy of Good

Advisory committees are not perfect, but I’ve never seen one that lacks a diversity of opinion. FDA scientists almost always raise important concerns that help committee members consider the risks and benefits of products and strengths and weaknesses of the research evidence.

In contrast, during the expert panel on hormones for menopause, the commissioner and the panel cited studies that, in several cases, were outdated, based on rodents rather than women, or included too few patients or were too short-term to provide meaningful evidence. There were no public speakers and no panel members willing to challenge those flawed research citations, so reporters under tight deadlines had little opportunity to include expert opinions that conflicted with the preordained message of the meeting.

Important FDA decisions deserve scientific scrutiny, challenging questions, differences of opinion, and nuanced summaries. These have, to date, been lacking in the FDA expert panels, making critical information less available to patients and their physicians.

Diana Zuckerman, PhD, is president of the National Center for Health Research in Washington, D.C. She is a former Congressional committee staffer who investigated FDA policies.

You can read the original MedPage Today article here.

Healio: HHS revises hormone therapy black box warning for menopause treatment

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

By Emma Bascom, Michael Monostra, and Andrew Rhoades, November 10, 2025

HHS has announced changes to estrogen hormone therapy black box labeling for menopause treatment in a move that it said corrects misleading warnings.

HHS Secretary Robert F. Kennedy Jr. said in a press conference on Monday that women have been “told to fear the very therapy that could have given them strength, peace and dignity through one of life’s most difficult transitions, menopause,” but “that ends today.”

“We’re challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts,” he added. “When prescribed responsibly and started early, hormone replacement therapy transforms the lives of women.”

The details

The role estrogen replacement should play in menopause treatment has long been controversial. Concerns about menopausal hormonal therapy stem back to the publication of findings from the Women’s Health Initiative in JAMA in 2002.

The study found women receiving estrogen plus progestin had a significantly increased risk for total CVD, stroke and pulmonary embolism, and a nominally increased risk for breast cancer. The trial was stopped early due to “health risks that exceeded health benefits over an average follow-up of 5.2 years,” and its results led to a large decrease in the use of hormone therapy among women.

In July, the FDA convened an expert panel to discuss the safety and efficacy of menopausal hormone therapy, and some members stated the boxed warning should be changed to better reflect the published evidence. In the press conference, FDA commissioner Martin A. Makary, MD, MPH, said the move is based on “a robust review of the latest scientific evidence” and the July panel.

“After 23 years of dogma, the FDA today is announcing that we are going to stop the fear machine steering women away from this life-changing, even life-saving, treatment,” Makary said. “We are also approving two new drugs for the treatment of menopausal symptoms. We are listening to doctors who have been waving the flag in the air saying, ‘Hey, we have this wrong.’”

[….]

In a viewpoint published today in JAMA, Makary and colleagues wrote that the revisions to the labels “signal a meaningful shift toward more nuanced, evidence-based communication of hormone therapy risks — one that prioritizes clinical relevance, distinguishes between different formulations and patient populations, and balances the narrative to reflect both safety and therapeutic value.”

According to the viewpoint, the label updates specifically include:

  • removing boxed warnings for CVD, breast cancer, probable dementia and stroke, but not the warning in systemic estrogen labels for endometrial cancer with unopposed estrogen, since “it is important to remind health care practitioners and patients that this serious risk can be mitigated by adding a progestogen”;
  • removing the recommendation that hormone therapy be prescribed at the lowest effective dose for the shortest possible duration, since “treatment decisions are individualized and fall within the clinical judgment of a clinician in discussion with a patient”;
  • updating timing information to include new guidance on treating women aged younger than 60 years or within 10 years of menopause onset “to optimize the benefit-risk balance”; and
  • tailoring safety information that reflects the risks most relevant to each specific type of hormone therapy product.

[….]

According to Makary and colleagues, current evidence suggests that starting hormone therapy within 10 years of perimenopause onset has long-term health benefits. It has been associated with a reduced risk for fatal cardiovascular events, bone fractures cognitive decline and Alzheimer’s disease, they wrote.

Expert insight

In a statement, Steven J. Fleischman, MD, MBA, FACOG, ACOG president, commended HHS, saying “the modifications to certain warning labels for estrogen products are years in the making, reflecting the dedicated advocacy of physicians and patients across the country.”

[…]

The Menopause Society also released a statement saying it agrees with the decision since “the boxed warning may have been a deterrent to the use of the low-dose vaginal estrogen, which is a safe and effective therapy for a condition that affects most menopausal women.”

“However, systemic estrogen still comes with potential risks that should be reviewed in detail with women initiating therapy,” the organization said. “Risks are greater when initiated in older women and in those who are further from menopause onset. Medical comorbidities, personal and family histories, symptoms, and personal preferences all need to be considered and reviewed with patients considering the use of hormone therapy for management of menopause symptoms or prevention of bone loss.” 

Diana Zuckerman, PhD, the president of National Center for Health Research, told Healio that “the warnings on hormone products for menopause had become outdated and it was time to update them.”

“However, these products still have clear risks, and the benefits are mostly for hot flashes and related symptoms,” Zuckerman said. “They are not the fountain of youth that some people claim, they absolutely are not proven to prevent dementia, and they are definitely not safe for everyone.”

Barbara DePree, MD, NCMP, MMM, director of the Women’s Midlife Services at Holland Hospital in Michigan, told Healio that the decision will likely increase hormone therapy uptake, which is “a win.” Yet she wondered how exactly HHS will tailor the safety information to reflect the most relevant risks for each type of hormone therapy.

“I’m not opposed to that, I’m just curious what data they’ll be using to tailor that information,” she said. “When the FDA panel happened, it felt like some of the benefits were cherry-picked from data.”

DePree was also concerned about claims that hormone therapy can prevent some very serious noncommunicable diseases.

“I’m fine with maybe taking some of the blinking red lights out of it. That gives women some more ease,” she said. “But I also think we’re not in a position to promote its use to prevent some conditions that we just don’t have the data to support, and I’m worried that it’s headed in that direction. With social media and what’s being overstated, I think this will maybe be another step in that direction, which is a little concerning.”

But she said this will likely give providers more confidence in offering the therapy as a safe alternative.

“We’ve had a whole generation of providers who’ve only grown up with data from the WHI, which basically put it completely in a risk category, and I think this brings it back to the middle for those people who’ve not really had the confidence or the understanding to properly screen women who can very safely and appropriately be using hormone therapy,” De Pree said. “We just don’t want it to say it’s the right option for every woman or just because it’s available everybody should do it because we’re going to save brains and hearts because I just don’t think we have the data to support that.”

Nanette Santoro, MD, professor and the E. Stewart Taylor Chair of OB/GYN at the University of Colorado School of Medicine told Healio that the changes “are a positive step for menopausal women and their physicians,” but was “a bit surprised the black box was completely removed.”

“The changes reflect current data, and it’s great that the route and types of hormones will be dealt with separately as the risks and benefits of estrogen alone compared to estrogen plus progestin are different. These changes should reduce physician anxiety about prescribing hormones, which is important because they are under-prescribed in general,” Santoro said. “And best of all, removing the black box from topical vaginal estrogen is a big relief, because the tiny incremental increase in circulating estradiol that occurs when women use these preparations should not be compared to the systemic dosing regimens and should not be considered to have the same risk.”

However, “some assumptions and statements made here that go way beyond the data that we have available,” which “raise a bunch of red flags for me.”  

“While hormone therapy can indeed be life-changing for symptomatic women, there is not randomized clinical trial evidence that it reduces heart disease, or immune and cognitive decline. There just isn’t,” Santoro said. “And when hormone therapy prescriptions abruptly dropped after the primary WHI publication in 2002, the only population health change that was seen, when hormone therapy went from about 25% of women to less than 2%, was a decrease in breast cancer mortality. There has not been any kind of massive morbidity or mortality as a result of this drop in hormones, although many women suffered with symptoms unnecessarily because of the fear.”

Overall, she said it is “a very good thing that women don’t have to try to decipher the estrogen black box warning (which includes the phrase ‘probable dementia’ and which confuses my patients who read it because they think it means they will probably get dementia if they take estrogen!) and their prescribing clinicians don’t have to have excessive fear of doing harm.”

“[But] the rebirth of the concept that estrogen and hormone therapy are a fountain of youth for women and will extend their lives feels a whole lot like a sharp swing of a pendulum back into the ‘feminine forever’ days.”
[….]

To read the entire article, click here 

Politico Prescription Plus: FDA Removes Black Box HRT Warning

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

Politico Prescription Plus

BY DAVID LIM AND LAUREN GARDNER, OCTOBER 11, 2025

MAKARY’S PRIORITY — In the Hubert H. Humphrey Building’s atrium in front of a crowd of HHS officials, doctors and journalists Monday, FDA Commissioner Marty Makary declared the agency is
urging companies to remove black box warnings for hormone replacement therapy for menopausal women.

[….]

“With few exceptions, there may be no other medication in a modern era that can improve the health outcomes of women on a population level than hormone replacement,” Makary said. “After 23 years of dogma, the FDA today is announcing that we are going to stop the fear machine steering women away from this life-changing, life-saving treatment.”

But the push to remove the warnings of breast cancer, cardiovascular disease and possible dementia isn’t clear-cut, and the process will likely take several months. Makary said the updated package inserts accompanying the treatments will include a nuanced discussion of the recommended ages for HRT use.

An HHS fact sheet released Monday says the FDA will advise women to start hormone replacement therapy within 10 years of menopause or before 60 years old for use of systemic HRT, which delivers the hormone throughout the body instead of a single area. And the FDA is not seeking to change its black box warning for endometrial cancer for systemic estrogen-alone products.

The background: The Women’s Health Initiative — a National Institutes of Health-backed study that looked at the treatments’ benefits and risks — halted a clinical trial in 2002 after researchers said breast cancer, blood clot and stroke risks outweighed the treatments’ benefits in relieving menopausal symptoms. The action prompted many women to stop the therapy.

But Makary slammed the study, saying it was misrepresented and created a “fear machine” around HRT for menopausal women. He argued the study did not show a significant link to breast cancer.

Diana Zuckerman, president of the National Center for Health Research, said it is “well established” that menopausal hormone therapy can increase heart disease and cancer risks in some circumstances.

“I am glad that the Commissioner admitted that there are risks of some types of hormone therapy for some women, but his claim that hormones for menopause is the best way to improve the health of women sounds like a PR statement,
not a scientific one,” Zuckerman said in an email.

Makary dinged advisory committees on Monday as “bureaucratic,
long and often conflicted, and very expensive” when asked why the

FDA did not opt to convene a panel of its outside advisers before making the recommendation.

[….]

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AFP: US to remove warnings from menopause hormone therapy

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

AFP (Agence France Presse); November 11, 2025

Hormone Replacement Therapy (HRT) replaces estrogen that the female body stops producing during menopause with the aim of alleviating symptoms including hot flashes, brain fog, insomnia, night sweats and joint pain.

Previously used routinely, prescription and use of the therapies have plummeted worldwide since a landmark trial in the early 2000s pointed to risks associated with specific HRT formulations.

Since then “black box warnings” — the strongest warning the US Food and Drug Administration can require on prescription drugs — have sounded alarm over increased HRT risks including of certain cancers, cardiovascular conditions and probable dementia.

But critics have pointed to flaws with the early 2000s Women’s Health Initiative, whose trials were halted as risks appeared: namely it focused on women who were a decade-post-menopause and in their 60s, when cardiovascular risks increase regardless.

Today guidance generally indicates that healthy newly menopausal or perimenopausal women — people broadly in their 40s or 50s — are among potential candidates for treatment.

There also are newer, more localized or lower-dose forms of the therapies available.

“We’re challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts,” US health chief Robert F. Kennedy Jr said in introducing the measure.

Many experts had urged revisiting the black box label, which they say can scare women for whom benefits may outweigh risks.

Others have voiced concern that changes shouldn’t come without a rigorous review process.

“The warnings on hormone products for menopause had become outdated and it was time to update them,” said Diana Zuckerman, president of the nonprofit National Center for Health Research.

But she told AFP “these products still have clear risks and the benefits are mostly for hot flashes and related symptoms of menopause, not for general health.”

FDA head Marty Makary dismissed that notion of an independent review committee, saying they are “bureaucratic, long, often conflicted and very expensive.”

Over the summer Makary convened a panel of experts overwhelmingly in favor of HRT, which included people with ties to pharmaceutical lobbying.

Adriane Fugh-Berman, who directs a project that promotes rational prescribing at Georgetown University, told AFP that Monday’s announcement was “embarrassing” as it was ahead of any consensus and was “not how regulation should happen.”

There could be benefits of HRT for some people, she told AFP, but cautioned that real risks remain, and more high-quality study is needed.

But the president of the American College of Obstetricians and Gynecologists, Steven Fleischman, commended the FDA’s move, saying “the updated labels will better allow patients and clinicians to engage in a shared decision-making process.”

[….]

The FDA said it is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products.

[….]

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The FDA removes long-standing warning from hormone-based menopause drugs

In the News, We're In the News

BY  MATTHEW PERRONE, November 10, 2025

Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about stroke, heart attack, dementia and other serious risks, the Food and Drug Administration announced Monday.

U.S. health officials said they will remove the boxed warning from more than 20 pills, patches and creams containing hormones like estrogen and progestin, which are approved to ease disruptive symptoms like night sweats. The change has been supported by some doctors — including FDA Commissioner Marty Makary, who has called the current label outdated and unnecessary. But some doctors worried that the process which led to the decision was flawed.

Health officials explained the move by pointing to studies suggesting hormone therapy has few risks when started before age 60 and within 10 years of menopause symptoms.

“We’re challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts,” Health Secretary Robert F. Kennedy Jr. said in introducing the update. The 22-year-old FDA warning advised doctors that hormone therapy increases the risk of blood clots, heart problems and other health issues, citing data from an influential study published more than 20 years ago.

[….]

Debate over the health benefits of hormone therapy
continues

 

Medical guidelines generally recommend the drugs for a limited duration in younger women going through menopause who don’t have complicating risks, such as breast cancer. FDA’s updated prescribing information mostly matches
that approach.

But Makary and some other doctors have suggested that hormone therapy’s benefits can go far beyond managing uncomfortable mid-life symptoms. Before becoming FDA commissioner, Makary dedicated a chapter of his most recent book to extolling the overall benefits of hormone therapy and criticizing doctors unwilling to prescribe it.

On Monday he reiterated that viewpoint, citing figures suggesting hormone therapy reduces heart disease, Alzheimer’s and other age-related conditions. “With few exceptions, there may be no other medication in the modern era that can improve the health outcomes of women at a population level more than hormone replacement therapy,” Makary told reporters.

The veracity of those benefits remains the subject of ongoing research and debate— including among the experts whose work led to the original warning.

Dr. JoAnn Manson of Harvard Medical School said the evidence for overall health benefits is not “as conclusive or definitive” as what Makary described. Still, removing the warning is a good step because it could lead to physicians and patients making more personalized decisions, she said.

“The black box is really one size fits all. It scares everyone away,” Manson said. “Without the black box warning there may be more focus on the actual findings, how they differ by age and underlying health factors.”

Hormone therapy was once the norm for American women

 

In the 1990s, more than 1 in 4 U.S. women took estrogen alone or in combination with progestin on the assumption that — in addition to treating menopause — it would reduce rates of heart disease, dementia and other issues.

But a landmark study of more than 26,000 women challenged that idea, linking two different types of hormone pills to higher rates of stroke, blood clots, breast cancer and other serious risks. After the initial findings were published in 2002, prescriptions plummeted among women of all age groups, including younger menopausal women.

Since then, all estrogen drugs have carried the FDA’s boxed warning — the most serious type.

[….]

Continuing analysis has shown a more nuanced picture of the risks.

[….]

Additionally, many newer forms of the drugs have been introduced since the early 2000s, including vaginal creams and tablets that deliver lower hormone
doses than pills, patches and other drugs that circulate throughout the bloodstream.

The original language contained in the boxed warning will still be available to prescribers, but it will appear lower down on the label. The drugs will retain a boxed warning that women who have not had a hysterectomy should receive a combination of estrogen-progestin due to risks of cancer in the lining of the uterus.

FDA sidestepped its usual public process in reviewing warning

 

Rather than convening one of FDA’s standing advisory committees on women’s health or drug safety, Makary earlier this year invited a dozen doctors and researchers who overwhelmingly supported the health benefits of hormone-replacement drugs.

Many of the panelists at the July meeting consult for drugmakers or prescribe the medications in their private practices. Two of the experts also spoke at Monday’s FDA news conference.

Asked Monday why the FDA didn’t convene a formal advisory panel on the issue, Makary said such meetings are “bureaucratic, long, often conflicted and very expensive.”

Diana Zuckerman of the nonprofit National Center for Health Research, which analyzes medical research, accused Makary of undermining the FDA’s credibility by announcing the change “rather than having scientists scrutinize the research at an FDA scientific meeting.”

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Inside Health Policy: FDA To Proceed With ‘Expert Panels’ Amid HRT Conflict Concerns

In the News, We're In the News

BY Luke Zarzecki , November 10, 2025

FDA will continue to be advised by “expert panels” instead of advisory committees in some cases, FDA Commissioner Marty Makary said as he touted the review method at an HHS event Monday (Nov. 10) announcing the removal of black box warnings from hormone replacement therapy products for menopause. Health research experts told Inside Health Policy the “expert panel” that advised Makary on the decision had conflicts since almost all of its members would benefit financially from the black box warning being eliminated.

Makary said advisory committees governed by the Federal Advisory Committee Act, FDA’s longtime method for consulting outside experts, are bureaucratic, long, often conflicted and very expensive. He added the agency can have spontaneous and more robust discussions with medical experts on the less-formal panels.

“We’re doing both advisory committees following the long, FACA process in the government and we are also convening experts to say ‘speak your mind passionately, state your conflict of interest if you have any, speak your mind passionately about an important topic in medicine that is not being talked about and needs to be talked about ’ and this was one of those panels,” Makary said. “We also had a similar forum on SSRIs in pregnancy, we had one on cell and gene therapies, so we are going to continue to have those it allows us to have a robust debate without all the bureaucratic barriers.”

[….]

The idea has sparked criticism. Inviting experts to temporarily testify on ad-hoc informal panels, rather than convening formal federal advisory committees with a charter and set membership, evades FACA disclosure requirements, critics say. Unlike advisory committee meetings, the expert panels do not require publication of a notice in the Federal Register, the keeping of minutes or a transcript, or disclosures from members about conflicts of interest.

HRT warnings

FDA said in a statement Monday it is removing the HRT warnings after a “comprehensive review of the scientific literature, an expert panel in July, and a public comment period.” The change removes references to risks of cardiovascular disease, breast cancer and probable dementia. The agency is not removing the boxed warnings for endometrial cancer for systemic estrogen-alone products.

“Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” HHS Secretary Robert F. Kennedy Jr. said. “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again.”

Conflicts of interest

Diana Zuckerman, president of the National Center for Health Research, told Inside Health Policy in a statement the members of the “expert panel” had conflicts of interest because “virtually all its members would benefit financially from the black box warning being eliminated”

“That’s because they would have more patients seeking their services, and that is a financial conflict of interest as well as a conflict caused by their becoming better known in their field,” she said.

[….]

Adriane Fugh-Berman, a Georgetown professor of pharmacology and physiology, told IHP Makary sought out experts who agreed with him on the topic.

“His handpicked ‘expert’ panels are put together to rubberstamp his preexisting views — they are rife with people with conflicts of interests, include unqualified people, lack any public comment section, and are full of people spouting their often uninformed opinions rather than assessing data,” she alleged.

HHS did not respond to IHP prior to publication on the alleged financial conflicts of interest.

Zuckerman said Makary thinks the only conflict of interests of importance are from pharmaceutical company funding. While the advisory committee system isn’t perfect, she said, FDA’s new format isn’t an improvement.

“In some cases it seems that the FDA designs advisory committee meetings to come to a specific conclusion, and they do that by ‘stacking the deck’ of the committee members as well as the FDA staff presentations,” she said. “Even so, FDA advisory committee meetings are usually much more scientific and nuanced than the recent ‘expert panels’ — a term that should always be in quotation marks because they are very one-sided and some of the ‘experts’ do not seem at all expert.”

Menopause treatment controversy

[….] 

The dispute over hormone therapy for menopause stems from a National Institutes of Health-backed trial of menopausal hormone therapy and its impact on risks of heart disease and other chronic conditions, part of the Women’s Health Initiative, which was halted in 2002 because of patient safety concerns. Researchers said the trial was showing an elevated risk of breast cancer, blood clots and stroke that outweighed the benefits.

Panelists at the FDA event in July said the findings of the Women’s Health Initiative (WHI) study were misinterpreted and the risks of hormone therapy for menopausal women have been overstated, while its benefits have been downplayed. The trial also focused on oral combination drugs, while other options for administration are available now.

Kennedy said Monday hormone replacement therapy reduces the risk of cardiovascular disease and mortality, Alzheimer’s disease, cognitive decline, bone fractures and all-cause mortality. He said the WHI study was not statistically significant.

“It triggered a media frenzy and led to the FDA applying unscientific black box warnings to all hormone replacement therapy products in 2003. The label was designed to frighten women and silence doctors,” he said.

But women’s health professionals urged FDA in August to avoid making changes to its boxed warnings on estrogen hormone therapy products without consulting an independent advisory committee, complaining the July panel included only supporters of hormone therapy.

Fugh-Berman said the WHI study demonstrated hormones do not prevent cardiovascular disease and increased the risk of dementia. She said that the risk of invasive breast cancer was significantly increased for patients who used HRT, and it increased progressively over time.

“Hormones also increase the risk of stroke, pulmonary embolism, gallbladder disease, ovarian cancer, and other conditions,” she said. “Makary’s statements that the breast cancer risk was not significant is entirely wrong.”

Zuckerman said it would be reasonable to revise the black box warning, but not to eliminate it, since some of the hormone products for menopause have scientific evidence that they cause uterine cancer and stroke for some patients, and breast cancer is also a risk for some women.

“In any other product, that would warrant a black box warning. That’s why removing the black box warnings from all hormone products for menopause is a step backwards, despite the FDA commissioner’s statement that these drugs would greatly benefit millions of women,” she said.

[….]

Zuckerman says topical creams have been shown to be safe in the short term, though long-term data is “skimpy.” Systemic hormones have clear risks and some clear benefits, she said.

“The warnings on hormone products for menopause had become outdated and it was time to update them. However, these products still have clear risks and the benefits are mostly for hot flashes and related symptoms of menopause, not for general health,” she said. “Hormones are not the ‘fountain of health’ that Dr. Makary claimed. They absolutely are not proven to prevent dementia and the frequently touted benefit for osteoporosis only lasts while the woman is taking the hormones, not after she stops.”

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