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NCHR Public Comment on the Continued Implementation of the National Youth Tobacco Survey

Policy, Testimony & Briefings

August 15, 2025

Re: Proposed Data Collection Submitted for Public Comment and Recommendations; Docket No. CDC–2024–0106

The National Center for Health Research (NCHR) appreciates the opportunity to submit these comments in strong support of the continued implementation of the National Youth Tobacco Survey (NYTS) for the 2026-2028 cycle. 

NCHR is a nonprofit think tank committed to advancing evidence-based policies that improve the health of adults and children. We focus on evaluating medical products, prevention strategies, and public health surveillance systems to ensure they are safe and effective. We are very concerned about the health risks associated with youth tobacco and nicotine use.

We strongly support the continued implementation of the National Youth Tobacco Survey (NYTS) for the 2026-2028 cycle. NYTS is the cornerstone of public health surveillance in this field. Discontinuing or significantly weakening it would create an irreversible gap in the nation’s health data infrastructure. The sustained operation of NYTS is an essential prerequisite for the effective implementation of public health strategies, and an essential component of the MAHA movement.

NCHR Recommendations

We respectfully urge CDC and FDA to jointly support and implement the National Youth Tobacco Survey for the 2026–2028 cycle, including the following priorities:

  1. Retain core trend measures to ensure continuity in time-series analysis, while expanding items that address emerging products (e.g., nicotine pouches, synthetic nicotine);
  2. Ensure oversampling of key populations, including but not limited to under-represented age groups, racial/ethnic minorities, and adolescents with mental health risks;
  3. Release the full public use dataset for each wave promptly and restore datasets from 2020–2023 which were recently removed from public websites; and
  4. Preserve CDC’s scientific leadership in survey design and analysis, while supporting strong interagency collaboration with FDA to ensure funding and continuity.

NYTS Is Irreplaceable for National Youth Tobacco Surveillance

Since its annual implementation beginning in 2004, the NYTS has remained the sole nationally representative source on tobacco and nicotine use among middle school students (grades 6–8) and the most comprehensive dataset for high school students (grades 9–12) [1]. NYTS captures a full spectrum of tobacco and nicotine products. These include traditional cigarettes, cigars, e‑cigarettes, heated tobacco, nicotine pouches, and newer synthetic products [2]. This dataset allows for the tracking of both established and emerging patterns of use. NYTS also measures behavioral variables, such as exposure to pro‑ and anti‑tobacco messaging, social norms, perceived harms, peer influence, pathways of access, dependence indicators, and cessation behaviors, along with contextual factors like mental health and school connectedness [1]. 

The NYTS is the only national survey that provides this level of detail on an annual basis. Surveys such as the Population Assessment of Tobacco and Health (PATH), which focuses on longitudinal regulatory research; the Youth Risk Behavior Surveillance System (YRBSS), which is limited to high schoolers and conducted biennially; and the National Survey on Drug Use and Health (NSDUH), which covers broader substance use across age groups, offer valuable data. However, none of them match the NYTS in comprehensive youth-specific tobacco surveillance [3]. The rapid release cycles of NYTS support timely and responsive policy action. For example, when JUUL’s popularity surged among youth between 2017-2019, NYTS was the only system capturing the magnitude and speed of adoption, a responsiveness that remains unmatched in national surveillance [4] [5].

NYTS Has a Proven Track Record and Will Contribute to MAHA Goals

NYTS data have driven some of the most consequential youth tobacco policies. For example, between 2017 and 2019, NYTS data showed that current e-cigarette use among high school students more than doubled, rising from 11.7% to 27.5%, prompting the FDA to declare youth vaping an “epidemic” and initiate enforcement actions restricting flavored products [6] [7]. These findings also informed the federal Tobacco 21 law, raising the minimum purchase age to 21, which is a milestone policy supported by evidence showing youth nicotine use trends [1] [8]. Furthermore, NYTS data underpinned evaluation of FDA’s “The Real Cost” campaign by tracking shifts in youth perceptions and behavior over time [1] [9] [10]. NYTS has also provided evidence that some youth are more at risk than others, which provides state and local governments with the information they need to develop policies to improve the health of all their children [1]. Taken together, NYTS has served as the early warning system that benefits federal and state health strategies.

NYTS provides the empirical foundation the FDA needs to fulfill its statutory mandate under the Family Smoking Prevention and Tobacco Control Act of 2009 to prioritize youth protection in tobacco regulation [4] [11]. Without it, the agency lacks a reliable means to monitor youth use trends, assess product-specific risk, or measure regulatory impact. Additionally, NYTS informs at least seven Healthy People 2030 objectives [2]. These include tracking adolescent use of e‑cigarettes, cigarettes, flavored products, and other nicotine-containing products [2]. In addition, state Youth Tobacco Surveys can be compared with NYTS data to better evaluate local progress.

In conclusion, youth nicotine and tobacco use are serious and constantly changing public health concerns. NYTS is the most reliable national system for identifying emerging trends and guiding effective prevention strategies. Discontinuing or weakening this survey would severely undermine efforts to reduce youth exposure to nicotine and tobacco products and to prevent long-term addiction.

We strongly support the full approval and continued implementation of this essential survey. For questions or further discussion, we can be reached at info@center4research.org

 

References

 

  1. Gentzke AS, Wang TW, Cornelius M, et al. Tobacco product use and associated factors among middle and high school students — National Youth Tobacco Survey, United States, 2021. MMWR Surveill Summ. 2022;71(5):1-29. doi:10.15585/mmwr.ss7105a1
  2. Centers for Disease Control and Prevention. About National Youth Tobacco Survey (NYTS). CDC Smoking and Tobacco Use. Updated May 15, 2024. Accessed Aug 11, 2025. https://www.cdc.gov/tobacco/about-data/surveys/national-youth-tobacco-survey.html
  3. Boakye E, Erhabor J, Obisesan O, et al. Comprehensive review of the national surveys that assess E-cigarette use domains among youth and adults in the United States. Lancet Reg Health Am. 2023;23:100528. doi:10.1016/j.lana.2023.100528
  4. Wang TW, Gentzke AS, Creamer MR, et al. Tobacco product use and associated factors among middle and high school students — United States, 2019. MMWR Surveill Summ. 2019;68(12):1-22. doi:10.15585/mmwr.ss6812a1
  5. Cullen KA, Gentzke AS, Sawdey MD, et al. e-Cigarette use among youth in the United States, 2019. JAMA. 2019;322(21):2095-2103. doi:10.1001/jama.2019.18387
  6. Creamer MR, Jones SE, Gentzke AS, Jamal A, King BA. Tobacco product use among high school students — Youth Risk Behavior Survey, United States, 2019. MMWR Suppl. 2020;69(1):56-63. doi:10.15585/mmwr.su6901a7
  7. US Food and Drug Administration. Spotlight on Science – Winter 2020. Updated January 9, 2020. Accessed Aug 11, 2025. https://www.fda.gov/tobacco-products/ctp-newsroom/spotlight-science-winter-2020
  8. Agaku IT, Nkosi L, Agaku QD, Gwar J, Tsafa T. A rapid evaluation of the US Federal Tobacco 21 (T21) law and lessons from statewide T21 policies: findings from population-level surveys. Prev Chronic Dis. 2022;19:210430. doi:10.5888/pcd19.210430
  9. The ASCO Post Staff. The Real Cost campaign may have prevented thousands of youths from initiating e-cigarette use. The ASCO Post. March 18, 2025. Accessed Aug 11, 2025. https://ascopost.com/news/march-2025/the-real-cost-campaign-may-have-prevented-thousands-of-youths-from-initiating-e-cigarette-use/ 
  10. Kowitt SD, Sheldon JM, Vereen RN, et al. The impact of The Real Cost vaping and smoking ads across tobacco products. Nicotine Tob Res. 2023;25(3):430-437. doi:10.1093/ntr/ntac206
  11. US Food and Drug Administration. Family Smoking Prevention and Tobacco Control Act – An Overview. Updated August 29, 2024. Accessed Aug 11, 2025. https://www.fda.gov/tobacco-products/rules-regulations-and-guidance-related-tobacco-products/family-smoking-prevention-and-tobacco-control-act-overview

FDA Panel Urges Caution, More Data on Dermal Filler Use in Decolletage Area

We're In the News

By Alicia Ault, August 14, 2025

A FDA advisory panel recommended that manufacturers of dermal fillers collect more information on use in the decolletage area of the body and said that some patients might be at higher risk of complications from injections because of the proximity to breast tissue.

The FDA has not approved dermal fillers for use in the decolletage — a body area that advisory panel members said was not well-defined. It is generally considered the triangular area that runs from the neck and clavicle area to in between the breasts.

Agency officials and committee members noted that fillers are increasingly being used off-label to improve skin texture, crepiness, skin thickness, fine lines, and wrinkles in the decolletage. The most common fillers used in the neck and decolletage are made up of hyaluronic acid (HA), calcium hydroxylapatite (CaHA), or poly-L-lactic acid (PLLA), according to the American Academy of Dermatology Association (AADA).

At a meeting on August 13, the FDA’s General and Plastic Surgery Devices Panel was asked to review safety concerns, in anticipation that manufacturers will soon seek FDA approval of fillers for use in the decolletage area and need guidance on trial design and post-marketing studies. The agency raised the possibility that fillers could migrate from the injection site or form nodules and/or granulomas and interfere with mammograms, cause false positive readings on breast imaging or clinical exams, or impact breast feeding and lymphatic drainage.

The committee — made up of dermatologists, plastic surgeons, oncologists, and radiologists — did not formally vote. The panel members agreed that patients who are breastfeeding or pregnant should be excluded from receiving injections because of the unknowns. Individuals with darker skin types or known wound-healing issues — both of whom might easily form keloids or nodules — or those with a history of radiotherapy, lymphoma, or other blood cancers were also seen as potentially higher risk populations, said panel chairman Hobart Harris, MD, MPH, the J. Engelbert Dunphy endowed chair in surgery at the University of California, San Francisco.

Sandra R. Shuffett, MD, a breast imaging specialist in Lexington, Kentucky, and temporary panel member, said she was concerned that fillers could obscure tumors on breast imaging tests. “My focus is to find a cancer as small as possible,” she said, adding that an unseen tumor could quickly grow larger, necessitating more serious treatment.

The FDA has not received reports of problems with breast feeding or imaging but a post-approval study of Radiesse (CaHA) found that it obscured bone visualization. There have also been reports of lymph node enlargement near dermal filler injection sites.

[….]

Radiesse manufacturer, Merz Aesthetics, told the panel that, between 2018 and 2025, it received 44 reports of potential adverse events in the decolletage area, with none reporting migration of material or radiological interference. Radiesse is approved for decolletage wrinkles in the European Union and Canada.

Social media may be fueling more use of fillers in the decolletage, especially among those taking GLP-1 receptor agonists for weight loss who are seeking “to improve the skin rippling in the chest,” said Karol A. Gutowski, MD, a Chicago-based plastic surgeon who spoke to the committee.

Representatives from dermatology and plastic surgery organizations said they had crafted guidelines for safe use of fillers in the decolletage but warned that filler use was often unregulated.

“Filler adverse events are likely under reported, and they’re increasing in frequency as the popularity of injectable fillers increases,” said M. Laurin Council, MD, director of dermatologic surgery at Washington University School of Medicine, St. Louis, who spoke to the panel on behalf of the American Society for Dermatologic Surgery.

Many panelists suggested women undergo baseline breast imaging before receiving filler in the decolletage area and collecting more data — such as on the volume of filler used during procedures — and added that perhaps a registry should be created. But some were skeptical.

“Probably 75% of these injections are done by non-medical people,” such as attendants at medical spas or storefront wellness centers, said panelist Alan Matarasso, MD, a New York City-based plastic surgeon and past president of the American Society of Plastic Surgeons. Matarasso said that manufacturers should be responsible for tracking their products, not clinicians.

“When these things are being done in strip malls and other places, we’re not going to get the data that we need, because people are not going to cooperate with this,” said Gutowski.

There is no approved method of removing dermal fillers. That gave some panel members pause. But dermatologists and plastic surgeons said that HA-based fillers could be dissolved with hyaluronidase. Even so, CaHA and PLLA fillers can’t be dissolved and “must break down naturally over time,” said Natalie Curcio, MD, MPH, a Nashville-based dermatologist who spoke to the panel on behalf of the AADA.

Temporary committee member Karla V. Ballman, PhD, professor of biostatistics at the Mayo Clinic College of Medicine and Science, Rochester, Minnesota, said that patients should be informed, perhaps via wording on a product label that “at the current time, there is no approved method of removal” of a filler.

[….]

At the panel meeting, consumer advocate Diana Zuckerman, PhD, president of the National Center for Health Research, said that listing adverse events was not enough. “Risks should be quantified with meaningful statistical data on the short term and long term risks,” said Zuckerman, who spoke during the open public hearing. “FDA should require well designed and full clinical trials so that patients have the information they need to make informed decisions,” she said.

[….]

Read full article here.

After 10 Years, the FDA Is Still Letting Women Down

In the News, News Stories & Editorials
By Michelle Llamas, BCPA August 14, 2025

In Drugwatch’s 2015 investigation, How the FDA Let Women Down, we highlighted issues with drug and medical device approvals that posed greater risks to women.

Now, we’re diving deeper into regulatory processes to highlight how far they’ve come — and where the administration still falls short in terms of device testing and clinical trials for medical products marketed toward women.

The FDA’s 510(k) clearance process is still allowing moderate-risk devices on the market without clinical trials. Some of these products, such as pelvic mesh, continue to hurt women.

The agency has also been working to approve drugs faster than ever, offering fast-track options for new drugs for serious illnesses such as cancer.

However, mistakes can lead to devastating outcomes when drugs are approved based on lower-quality data. In some cases, the FDA proposed using one clinical trial with patients instead of two to approve drugs faster.

More recently, the FDA has championed AI to help achieve faster drug approvals, but AI has been known to produce false data.

As health care evolves, so do women’s needs and safety concerns. Stronger data and testing requirements can help protect women from dangerous medical devices and drugs.

Medical Approval Processes May Fall Short

While the FDA requires clinical trials for drugs to hit the market, a large number of medical devices are sold without trial data — exposing women and men to health risks.

The 510(k) clearance process allows medium-risk (Class II) medical devices like surgical mesh, some hip implants, catheters, pregnancy tests and others on the market without clinical trials as long as they are similar to devices already on the market.

[….]

Drug approvals, on the other hand, require more testing and clinical data for the FDA to approve them. However, in some cases, the quality of the data submitted may be an issue, and drugs could be approved based on lower standards.

Medical Devices: Inadequate Testing, Conflicts of Interest and Delayed Warnings

Donna Miser’s doctor implanted a surgical mesh bladder sling that was supposed to help her with stress urinary incontinence (SUI), a condition that causes urine to leak when there’s increased pressure on the bladder. Exercising, sneezing or coughing can all trigger these leaks. SUI affects 1 in 3 women.

But no one told her about the risks of mesh.

The implant is supposed to be permanent, but after a few years, the mesh eroded into her bladder and vaginal walls and cut into her urethra in multiple places. She’s since had several surgeries to remove the mesh.

“Someone’s really dropped the ball. I do not understand how so many women got implanted with [this] product. That surgeon looked at me with a smile on his face, telling me, ‘I have got the answer. I’ve got the cure for you. We’re going to put this in you,’” Miser told Drugwatch. “It wasn’t tested. It wasn’t approved.”

[….]
When Miser said her mesh wasn’t tested or approved, she wasn’t wrong. The 510(k) process allows devices to be approved without clinical trials if they are similar to products already on the market, which are called predicate devices.

The issue with 510(k) approvals is that products can enter the market based on similarities to decades-old devices. This was the case with the surgical mesh implanted in women for SUI or pelvic organ prolapse (POP), a condition where organs slip down and bulge into the vagina.

Another, more rigorous (but less frequently used) path to device approval, Premarket Approval (PMA), requires more scientific evidence. The PMA is intended for high-risk Class III medical devices, such as pacemakers or defibrillators.

Mesh implanted through the vagina for POP has since been reclassified to a Class III device and now requires more testing before it’s sold, but SUI mesh remains a Class II.

[….]

“Missing Safety Device Data May Delay FDA Warnings

The FDA’s Manufacturer and User Facility Device Experience (MAUDE) system is a searchable database for medical device complications. The FDA uses it to flag safety data and determine if it needs to take action.

Madris Kinard of Device Events used to work at the FDA as an adverse events subject matter expert for devices and unique device identification (UDI). Kinard spoke to Drugwatch and cited a report on a problematic birth control device called Essure. With Essure, doctors implanted two metal coils into the fallopian tubes. This caused scar tissue to develop, blocking the tubes and preventing sperm from reaching the egg.

Women reported thousands of complications from Essure that led them to get it surgically removed.

Kindard’s FDA database analysis showed that about 32,000 device complaints from inspections of Essure’s manufacturer in 2011 and 2013 hadn’t made it into the FDA’s database. Kinard said it’s not clear whether these complaints contained adverse event reports because the details haven’t been made public. The FDA still hasn’t responded to her Freedom of Information Act (FOIA) request.

If that data had been added to MAUDE, it might have given the FDA more information to warn women about Essure sooner.

“That set them back by probably 10 years in identifying these problems,” Kinard said.

[…]

Drugs: Poor Evidence for Approval, Improper Doses for Women and Underrepresentation in Clinical Trials

Unlike the 510(k) clearance pathway for medical devices, drugs require more clinical trial data for approval. One of the most important parts of the drug approval process is when the FDA looks at the risks and benefits from clinical trial data submitted by a manufacturer. The FDA expects the manufacturer to conduct two well-designed clinical trials, but in some cases, it will accept one.

To determine if drugs work safely, the FDA uses four minimum criteria to judge whether manufacturers have provided enough evidence for drug approval.

A new report from The Lever and the McGraw Center for Business Journalism at CUNY’s Newmark Graduate School of Journalism analyzed a government database and looked at 429 drugs approved by the FDA from January 2013 to December 31, 2022.

The report revealed that the FDA approved these drugs without clinical trials that met the minimum four criteria of having a control group, blinding, replication or clinical endpoints.

“More medical products have been allowed on the market in the last decade based on skimpier research, or research studying biological markers that patients can’t feel (such as plaques on the brain or bone density) rather than meaningful health benefits such as living longer or spending less time in a hospital,” Diana Zuckerman, President of the National Center for Health Research and a project advisor for The Lever, told Drugwatch.

Investigative journalists Jeanne Lenzer and Shannon Brownlee spearheaded the database project and found several surprises in the data.

“We knew going in that the FDA had relaxed its scientific standards over the years and that the result was drugs getting on the market without adequate evidence that they work,” Lenzer told Drugwatch. “We didn’t know just how bad it was.”

Lenzer and Brownlee were also surprised by how many cancer drugs in the data they pulled made it to the market without adequate proof they work. The exact cancer medications are included in the table above.

[….]

Improper Dosing Can Lead to More Side Effects For Women

Women experience side effects nearly twice as often as men, and one of the reasons is that medications take longer to leave women’s bodies.

Even with researchers recommending dose reductions for women, the FDA hasn’t taken meaningful action to require sex-specific dosing information on drug labels.

One study in Biology of Sex Differences looked at 86 drugs and found that (when compared to men), women generally had higher blood concentrations of the drugs, and the medications took longer to leave their bodies. This led to higher rates of side effects in women in 96% of cases.

The findings in this study suggest that women may have been prescribed higher doses of drugs than necessary, even when they take the dose recommended on the drug’s label or as directed.

Medications studied included common OTC and prescription medications such as aspirin and Zoloft (sertraline).

[….]

Older Women and Women of Color Still Underrepresented

When we interviewed Zuckerman in 2015, she highlighted the lack of women, people of color or people over age 65 in clinical trials. Over the past 10 years, the FDA has increased the number of women in clinical trials, but still lags behind with women of color and older women.

“Most trials submitted to the FDA include quite a few women, but they are not women of color or women over 65, even though many diseases are more common on people over 65 and at least as prevalent in people of color,” Zuckerman told Drugwatch.

While it’s great that more women are finally included in trials, the benefits might not be seen for a few years. Most drugs on the market today were approved during older clinical trials. The data from these trials were primarily gathered from men, leaving a gap in safety data for women.

Expert Opinion: How Can the FDA Improve Drug Safety?

When it comes to drug safety, the FDA needs to require more stringent clinical trial evidence before allowing drugs onto the market.

“The problem for the agency is it is now hamstrung by Congress, which has, over the years, steadily eroded the statutes governing drug regulation,” Lenzer said. “In addition, we believe that PDUFA has to be repealed.”

The PDUFA, or Prescription Drug User Fee Act, allows the FDA to collect fees from drugmakers in exchange for expediting their medications’ reviews and approvals.

“Nobody wants to talk about that because it would almost certainly require public funding, but an agency that is paid by the industry it is supposed to regulate — almost by definition — cannot be independent. What that means for the FDA is it no longer protects the public health and patients because it’s too busy protecting the commercial interests of its benefactors,” Brownlee added.

[….]

This excellent article has many examples of specific medical products that are unsafe, and provides more information about what needs to be done.  You can read the entire article at https://www.drugwatch.com/featured/fda-still-letting-women-down/
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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

Uncategorized

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