Drugwatch, August 14, 2025: This excellent 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.
Read More »News That Quotes Us & Our Work
We are often quoted in major newspapers and magazines, and on well-respected TV shows, radio programs, and websites where we share our opinion on issues that matter to you and your health. Stay up to date on health news and our take on it by reading the articles in this section.
FDA Panel Urges Caution, More Data on Dermal Filler Use in Decolletage Area
Medscape, August 14, 2025: 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
problems.
Stakeholders at odds over FDA’s draft guidance on hernia mesh labeling
Regulatory Affairs Professional Society, August 11, 2025: This article published by the Regulatory Affairs Professionals Society provides an excellent summary of key responses to the FDA’s request for public comment on regulations for hernia mesh. It clearly shows the conflicting perspectives of the device industry and healthcare experts about patients’ need for specific information about the risks and benefits of hernia mesh.
Read More »Medical device industry says future MDUFA hikes unsustainable
MedTech Dive, August 5, 2025: NCHR’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.
Read More »Inside Health Policy: Prasad Leaves FDA After Sarepta Furor, Conservative Backlash
Inside Health Policy, July 29, 2025: Vinay Prasad leaves his key post at the FDA after a conservative backlash from Laura Loomer and WSJ. Sarepta’s gene therapy Elevidys has killed 2 patients so Prasad’s concerns were appropriate and the opposition is not focused on the evidence. We point out that FDA must require better evidence that Elevidys is safe & effective and should limit access meanwhile in order to restore trust in the FDA and the gene therapy.
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