Caroline Bradford

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.

Stakeholders at odds over FDA’s draft guidance on hernia mesh labeling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.

NCHR Comment on Hernia Mesh Package Labeling Recommendations

Why are there tens of thousands of reports to FDA of patients harmed by mesh used in hernia repair? NCHR points out that the FDA proposed guidance is unlikely to reduce that harm because it does not point out the many serious risks of mesh. We tell the FDA that mesh labeling should have warnings about frequency of the many adverse events of specific mesh products, and FDA should require research to determine which products are safer and which are more dangerous, and for which patients.

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.