In our public comment to the CDC, we strongly supported the continued operation of the National Youth Tobacco Survey (NYTS) for the 2026-2028 cycle. NYTS is the cornerstone of public health surveillance in this field and we reminded CDC and FDA that evaluating the youth use of tobacco products is an essential tool of U.S. public health strategies to reduce cancer, heart disease, and chronic diseases that are key to the MAHA movement.
Read More »Author: Caroline Bradford
After 10 Years, the FDA Is Still Letting Women Down
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 »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.
NCHR Public Comment on Improving the Generic Drug User Fee Act (GDUFA IV)
National Center for Health Research’s written comment on GDUFA IV urges the FDA to use generic drug user fees to pay for staff and resources that improve generic drug safety and equivalence, not just speedy review. We point out that hundreds of generic drugs that are still for sale have been found to be contaminated, the wrong dosage, or otherwise unsafe or ineffective for patients. To regain the trust of all patients and health professionals, FDA needs to do more testing and inspections and make sure that bad drugs are recalled.
Read More »Stakeholders at odds over FDA’s draft guidance on hernia mesh labeling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.
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