Top drug regulator Richard Pazdur set to leave the FDA – STAT reports Pazdur sudden FDA retirement as CDER head as we agree with industry in questioning if FDA can function as a scientific and public health agency when it can’t keep dedicated staff amid controversial decisions on vaccines and other medical products.
The FDA Commissioner Is Missing the Point of Advisory Committees – Diana Zuckerman’s oped in MedPage Today says FDA was never perfect but the media and public could see how the agency reviewed risks and benefits when they held public meetings where scientists and public citizens debated controversial medical products. In recent months they’ve switched to one-sided rubber stamp meetings followed by announcements of their decisions at events that feel like pep rallies. For example, research shows that hormones for menopause can be helpful or harmful, depending on your age and the type of hormones and your personal medical history. They are not safe for everyone, and can cause cancer, strokes, and dementia for many women. But the FDA expert panel focused on the benefits and ignored most of the risks.
Healio: HHS revises hormone therapy black box warning for menopause treatment – Healio.com reports Commissioner Makary and HHS Secretary RFK Jr. plans to eliminate black box warnings on menopause hormone therapy but they exaggerate hormone benefits say Drs. Diana Zuckerman, Barbara DePree and Nanette Santoro.
Politico Prescription Plus: FDA Removes Black Box HRT Warning – Politico, November 11, 2025: FDA Commissioner Marty Makary announces that FDA seeks eliminating most black box warnings from hormone therapy for menopause and accuses “dogma” that scared women. CPTF’s Diana Zuckerman said risks of cancer and heart disease are well established and claims of incomparable benefits are PR rather than science.
AFP: US to remove warnings from menopause hormone therapy – AFP News, November 11, 2025: France 24 explains FDA decision to delete most black box warnings for hormone therapy for menopause, despite controversies about the risks. CPTF’s Diana Zuckerman says warnings needed to be updated but hormones have serious risks and limited benefits.
The FDA removes long-standing warning from hormone-based menopause drugs – AP News, November 10, 2025: AP explains FDA decision to delete most black box warnings for hormone therapy for menopause, despite controversies about the risks. CPTF’s Diana Zuckerman says FDA lost credibility for deleting such important warnings without scientific review using FDA Advisory Committee.
Inside Health Policy: FDA To Proceed With ‘Expert Panels’ Amid HRT Conflict Concerns – Inside Health Policy, November 10, 2025: Inside Health Policy describes controversy about FDA “Expert Panels” and quotes CPTF Diana Zuckerman on why these panels have conflicts of interest and eliminating menopausal hormone therapy black box warnings about cancer and heart disease is a mistake.
FDA ‘serious’ about hormone therapy changes – Politico, October 28, 2025: Politico predicts FDA will revise black box warnings on hormones for menopause, but it isn’t clear how. CPTF’s Diana Zuckerman explains warnings are needed but require more nuance because the evidence is different for hormone creams compared to pills, and evidence of risks and benefits for pills depend on factors such as the type of hormones and the age, medical history, and other differences in the women.
New Blood Tests for Early Cancer Detection Get Some Love From House Members – MedPage Today, September 18, 2025: This news article describes Energy & Commerce Health Committee hearing on bills that would require Medicare cover Breakthrough devices and controversial Multi-cancer Screening tests. NCHR president Dr. Diana Zuckerman testified, describing the cancer tests as “not ready for prime time” and explaining that the latest research shows they are very inaccurate, with some having a false positive rate over 90%
FDA Leaders Moving to Abandon Advisory Committee Reviews of Specific New Drugs – STAT News, September 12, 2025: FDA seeks to abandon Advisory Committees for specific drugs and use them for bigger issues says CDER head George Tidmarsh. We point out that Expert Panels are also replacing Advisory Committees with one-sided reviews.
FDA Panel Urges Caution, More Data on Dermal Filler Use in Decolletage Area – Dr. Diana Zuckerman urged the FDA to require better research and quantify risk information at the Aug 2025 FDA Advisory Panel reviewing risks of dermal fillers in decolletage area above the breast. We agreed with panel members concerns that filler could interfere with cancer diagnosis and breastfeeding, and cause a stroke. We also pointed out that this cosmetic procedure can cause pain, swelling, bruising, and lumps could last weeks or months, which will undermine any cosmetic improvement. Panel members also focused on risks of interfering with cancer diagnosis and breastfeeding
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After 10 Years, the FDA Is Still Letting Women Down – This excellent Drugwatch article explains that FDA lets women down when they approve drugs and devices for cancer and many other serious diseases, which often don’t work well on women and can be harmful. The article quotes Dr. Diana Zuckerman and other experts, and provides examples of specific medical products that you may have used or want to avoid.
Medical device industry says future MDUFA hikes unsustainable – MedTech Dive, August 5, 2025: CPTF’s Diana Zuckerman and Patient, Consumer, and Public Health Coalition’s Tess Robertson-Neel are quoted in the MedTech Dive’s article about the MDUFA VI meeting at FDA in August 2025. Alex Baum of Coalition member Generation Patient is also quoted. They focused on including patient and consumer stakeholders in MDUFA negotiations and using user fees for post-market safeguards and other efforts to improve the quality of medical devices.
F.D.A. Panel to Reassess Hormone Therapy Warnings – New York Times July 17, 2025: This FDA panel hosted by Commissioner Makary ignores evidence of the serious risks of hormone therapy for menopause, such as breast cancer, endometrial cancer, and stroke. Instead it focuses only on benefits, relying on misleading and erroneous information. The panel wants to remove the “black box” warning that tells women about the risks. No public comment was allowed at the meeting. We would have disagreed strongly, except with the issue of whether hormonal cream used in the vagina should not have the same black box warning as the hormonal pills.
FDA Panel to Revisit Menopausal Hormone Therapy – Politico describes the FDA panel on the risks and benefits of hormone therapy for menopause: breast cancer, heart disease,stroke, dementia. Zuckerman points out that the panel is one-sided, ignoring data on risks and not allowing public comments from patients or experts to ask questions or describe studies indicating cancer and other serious risks.
RFK Jr.’s Planned Assault on Corporate Influence Is Clashing With Reality – June 26, 2025: NOTUS news article gives numerous examples from experts who agree with RFK Jr and Makary criticisms of corporate influence on health, but say HHS plans to reduce conflicts of interest are ineffective and FDA remains overly influenced by industry.
In Vague Announcement, FDA Says It Will Cut Ad Comm Conflicts – April 17, 2025, IHP News: Inside Health Policy reports FDA‘s new conflict of interest policy looks like its old conflict of interest policy. CPTF’s Diana Zuckerman and Public Citizen’s Michael Abrams ask how is this new policy different from the existing policy? Industry representatives are already not allowed to vote on FDA advisory committees.
Canadians could lose vital safety information amid deep cuts to the U.S. FDA, experts warn – CTV News, April 13, 2025: Canadian and U.S. experts explain how huge cuts in FDA staff made by the Trump Administration can harm public health in U.S. and Canada, especially by delaying recalls in unsafe medical products and food.
RFK Jr. brings FDA under tighter control with HHS workforce cuts – STAT News, March 27, 2025: We explain why RFK Jr’s plan to cut 3,500 FDA staff will be “extremely disruptive and not productive” for at least a few years. Reviewers’ and inspectors’ productivity will be hurt even if they are not cut and as a result patients and industry will be harmed because new drugs and devices will not be reviewed as quickly or as carefully. RFK’s plans to remove toxic chemicals from food and food packaging will require more staff, not fewer. Why were these cuts decided before the new FDA Commissioner was in place at the FDA and had the opportunity to decide what would be best for the agency and the public?
Pfizer hires FDA drug regulator Cavazzoni, sparking revolving door debate – Politico, February 24, 2025: FDA Director of Drug Center (CDER), Cavazzoni, returns to Pfizer, where she worked before going to the FDA. NCHR and other experts say this revolving door undermines trust in the FDA and highlights concerns about the cozy relationship between the FDA and industry that can weaken standards of safety and effectiveness.
FDA webpages on clinical trial diversity removed after Trump orders – MedTechDive, January 27, 2025: FDA webpages on how to improve diversity in clinical trials and other topics were immediately removed after Trump was inaugurated and ordered numerous federal agencies to pause in communicating with the public. We explain that diversity in clinical trials is not affirmative action, it is needed to ensure that medical products are safe and effective for males and females and for people of all ages and races. The new FDA Commissioner hasn’t been confirmed, so who made these decisions?
In debate over obesity medications, FDA shifts toward importance of drugs in subtle ways – January 10, 2025: The FDA’s new guidance to Pharma on how to develop weight loss drugs reflects a cultural shift that treats drugs as the first resort instead of the last resort if changing eating habits and exercising doesn’t work.
Trump’s pick for FDA to test ‘due diligence’ of Agency’s science – Bloomberg Law, November 25, 2024: Dr. Marty Makary has been named by Donald Trump to lead the FDA. The Johns Hopkins surgeon has been an outspoken critic of FDA’s relationships with industry and his appointment could shake up the status quo. NCHR and other experts are optimistic that Dr. Makary will encourage the agency to reduce conflicts of interest and hold industry to a higher standard for FDA approval of medical products and food safety.
Vivek Ramaswamy’s crusade to change FDA could boost biotech, and himself – The Washington Post, November 25, 2024: This news article quotes NCHR and other experts explaining that Vivek Ramaswamy is a former biotech executive who is very critical of the FDA in ways that reflect his extensive conflicts of interest. If Donald Trump follows Ramaswamy’s advice, Ramaswamy is likely to greatly increase his wealth and patients will be harmed by paying for expensive new medications that do not work.
What Trump’s election win could mean for AI, climate and health – Nature, November 8, 2024: Nature magazine news article on the impact of Trump election includes views regarding health programs. CPTF asks if RFK Jr. stated plans to “reduce corporate greed” will be implemented, given the close ties between the first Trump Administration and the pharmaceutical industry.
Michelle Tarver faces challenges as new CDRH leader. But patient groups, industry are optimistic. – October 31, 2024: MedTech Dive news article quotes industry officials and CPTF and other patient and consumer advocates about new CDRH director Michelle Tarver and hopes for greater respect for patients, consumers, and researchers during user fee negotiations and FDA decision-making regarding the safety and effectiveness standards for medical devices.
F.D.A. names a new chief of medical devices – New York Times, Oct 22, 2024: Michelle Tarver is the new director of CDRH, FDA medical device center, promoted from within the agency. We are hopeful that she will move CDRH to focus more on ensuring safe and effective medical devices, reversing the bias of former director Jeff Shuren. But given her expertise, why has the agency failed to warn Lasik patients as promised?
High Levels of Toxic Flame Retardants Found in Toys, Kitchen Utensils Made From Black Plastic – The Defender, October 2, 2024: Researchers found toxic flame retardants in everyday items made from contaminated recycled black plastic food containers, kitchen utensils, and toys. These toxins are linked to cancer, endocrine disruption, neurotoxicity, and reproductive harm. Plastic recycling is to blame. It is time to come to terms with the misinformation about plastic recycling and demand that FDA and EPA ban unsafe recycled plastic products.
FDA to launch ‘active’ monitoring system to improve medical device safety – Association of Health Care Journalists, September 18, 2024: AHCJ questions the usefulness of FDA’s new active monitoring system to improve medical device safety and NCHR and other experts do too. The FDA plans to start by monitoring two types of devices in the first year but there are thousands of devices that were never studied for safety or effectiveness so that is not going to keep patients safe anytime soon.
The untold trauma of thousands of women suffering from ‘Breast Implant Illness’, leaving them in agony for years… yet some doctors refuse to accept it is real – The Daily Mail, September 9, 2024: After making the decision to decrease her cancer risk by removing her breasts and getting implants, one woman discovered a community of women suffering from breast implant illness. Celebrities describe similar health problems from implants and recovery after implants are removed. Despite popularity of explant surgery and mounting evidence of BII, many doctors continue to dismiss breast implant illness, leaving women dependent on online support groups for information. FDA has not ensured accurate information for patients.
He Regulated Medical Devices. His Wife Represented Their Makers. – The New York Times, August 20, 2024: Ever wonder why there are so many ineffective and unsafe implants and diagnostic tests and other medical devices harming patients? This NYT investigation explains how FDA official Jeff Shuren was involved in decisions that benefited his wife — who worked for Theranos and other major device companies. Why did FDA allow that to happen year after year?
Open Letter to the FDA: You’re Protecting the Wrong People – MedShadow, July 23, 2024: We agree with Medshadow that it is outrageous that the FDA is warning companies about fraudulent tests that mean their medications may not be safe or effective but are not warning patients who are buying these medications.
Revolving door: You are free to influence us “behind the scenes,” FDA tells staff leaving for industry jobs – BMJ, July 1, 2024: BMJ investigation reveals how revolving door and FDA Ethics office allow former FDA staff to lobby for industry and Dr. Diana Zuckerman explains how this creates conflicts of interest that undermine FDA decision-making.
FDA Brings Lab Tests Under Its Oversight – April 29, 2024: FDA issues the final rule for lab-developed tests (LDTs) and we explain that the rule has a giant deadly loophole allowing thousands of diagnostic tests and genetic tests for cancer and other deadly diseases to be sold without evidence they are accurate.
Feds declare turf, rubber playgrounds “generally safe’ – Politico E&E NEWS, April 18, 2024: EPA released its 2024 report on artificial turf, which says it contains dangerous chemicals but that the exposures are “generally safe.’ NCHR’s Dr. Diana Zuckerman asks what does that mean? If it is generally safe that means it isn’t safe for everyone, but EPA doesn’t explain how many will be harmed and doesn’t explain what is known and not known. It’s not credible.
Why journalists should scrutinize the FDA’s accelerated drug approval process – March 7, 2024 article by Association of Health Care Journalists explains the problems with the FDA accelerated approval process and gives advice on how to cover the evidence accurately. NCHR’s Diana Zuckerman explains that when FDA rescinded approval of the cancer drug Pepaxto, it was an easy call because the company took it off the market 2 years ago because of the higher death rate in a clinical trial.
FDA Warned of Overstepping Authority With Lab Test Rule Proposal – Bloomberg Law, December 7: Bloomberg Law news article describes the strong opposition to FDA’s plan to regulate lab-developed tests (LDTs). We explain why patients can’t trust the results of these diagnostic tests unless FDA makes sure they are accurate.
Consumer and Public Health Groups Support FDA Proposal to Ensure Accuracy of Lab-Developed Medical Tests – September 29, 2023: A coalition of consumer advocacy groups is welcoming a proposed rule released today by the Food and Drug Administration to regulate laboratory-developed tests (LDTs), a category of diagnostic tests developed and used in a single lab.
Are PIP rubber playgrounds safe for Kingston? – October 23, 2023, CPTF president Diana Zuckerman’s oped in the Kingston (NY) Wire explains the risks to children of lead and carcinogenic chemicals in PIP rubber playground surfaces and artificial turf in Kingston and other communities.
Who gets to decide who receives experimental medical treatments? – This excellent news article by MIT Technology Review asks “Who decides who receives experimental medical treatments” and are FDA’s standards for accelerated approval too low for Duchenne Muscular Dystrophy, cancer, and other diseases. We call accelerated approval a disaster.
Biden’s Crackdown on ‘Junk’ Plans: Minimal Impact on Payers – Health Payer Specialist, July 14, 2023: The White House proposes restricting “junk” health insurance policies to 3-4 months for emergencies, instead of 3 years. These health insurance policies are supposed to be for short-term emergency coverage, not to replace comprehensive health insurance. We explain that these inexpensive policies result in patients paying much more if they have any medical needs – or going without important medical care. Don’t be fooled by misleading ads for cancer coverage or other limited coverage.
Lilly battling rivals for breast-cancer patients – Indianapolis Business Journal, June 9, 2023: We explain to the Indianapolis Business Journal that 3 drug companies are spending $millions to persuade breast cancer patients that their drug is best despite risky side effects. Their ads are confusing and misleading.
For Canadian Patients, Therapeutic Psychedelics Beset by Red Tape – Undark, March 8, 2023: Undark article reviews the red tape in Canada vs. U.S. for access to psychedelics for cancer patients and other depressed patients. In this news article, we explain FDA expanded access program, which tends to make access easier if companies agree to help patients.
Many pediatric drug study results were never posted to a U.S. government database – STAT News, January 24, 2023: Results of 43 clinical trials involving thousands of children were never reported to clinicaltrials.gov or published in a medical journal or otherwise made publicly available, as required by law. We explain how this harms children and families.
Lawmakers, advocates press for diversity in clinical trials – National Journal, February 15, 2023: NCHR joins lawmakers and other advocates in urging FDA and NIH to improve diversity in race/ethnicity, age, and sex in clinical trials as a way to improve medical care for everyone. So far, enforcement is lacking.
A Tiny Lab Finds Danger on Drugstore Shelves While the FDA Lags Behind – Bloomberg News, November 9, 2022: Valisure is a small lab that found carcinogens in Zantac, sunscreen, shampoo, sanitizers, and other products. NCHR asks: Why isn’t FDA doing these routine impurity tests? Too cozy with industry?
A Special Report: Can Breast Implants Cause Chronic Disease? – HealthCentral, October 25, 2022: This excellent review from HealthCentral.com quotes breast implant patients, NCHR and other experts responding to new FDA warnings and troubling research. We explain the research evidence of risks of breast implant illness and lymphoma and point out the misleading denials of risk by plastic surgeons.
Opinion: Are Turf Fields a Safe Place for Kids to Play in Westfield? – Dr. Diana Zuckerman, PH.D, Tap into Westfield: September 12, 2022 As a mother, I used to think that artificial turf and rubber playground surfaces were a clever and attractive alternative to grass fields. As a scientist, however, I learned that my children were being exposed to unsafe chemicals without my knowledge or consent. I recently wrote … Continue reading Opinion: Are Turf Fields a Safe Place for Kids to Play in Westfield?
Letter to the Editor: Asphalt playgrounds are bad for kids. So is artificial grass – Los Angeles Times and Yahoo News, September 7, 2022 To the editor: It’s frightening that L.A. schoolchildren are playing on sizzling asphalt, but the commentary and reporting on it miss an important part of the story. Years of research show that the school playground surfaces that are even hotter than pavement are made from artificial turf or colorful rubber. On … Continue reading Letter to the Editor: Asphalt playgrounds are bad for kids. So is artificial grass
Trump Covid Report Stirs Calls for FDA to Rebuild Public Trust – Celine Castronuovo and Jeannie Baumann, Bloomberg Law, August, 26, 2022 A House report detailing coordinated attempts by Trump White House officials to influence the FDA’s pandemic response underscores the need for more transparency at an agency that’s facing historically low public trust, health policy analysts say. The House Select Subcommittee on the Coronavirus Crisis said this … Continue reading Trump Covid Report Stirs Calls for FDA to Rebuild Public Trust