August 13, 2025: Diana Zuckerman testified at the FDA panel meeting about the risks of dermal filler for decolletage. Known risks include pain, lumps, rashes, stroke, and interference with breast cancer screening. We explained that patients and their physicians need specific information about the frequency of these risks so that they can make informed decisions about whether they want this cosmetic procedure.
Read More »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
NCHR Public Comment on the Continued Implementation of the National Youth Tobacco Survey
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 »NCHR Written Comments on the Reauthorization of PDUFA
August 14, 2025: National Center for Health Research written comment urges FDA to use PDUFA user fees to improve drug safety and effectiveness, not just faster approvals. All programs included in Commitment Letter should emphasize the scientific standards and evidence that will ensure that drugs and biologics have meaningful benefits for patients that outweigh any risks.
Read More »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 »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.
Only social media should be: X/Blueky: Why have tens of thousands of patients been harmed by mesh used in hernia repair? FDA’s proposed solution will not solve the problem of dangerous mesh complications.