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 »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 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.
Read More »Testimony of Dr. Diana Zuckerman at the FDA Advisory Committee on Oncological Drugs on Benrep for Multiple Myeloma
July 17, 2025: Dr. Diana Zuckerman testifies for NCHR about GSK study flaws of Benrep at FDA Oncology Drugs Advisory Committee. The very high risks of ocular toxicity outweighs the benefits and other better treatments are available.
Read More »FDA Public Meeting on MDUFA VI: Invited Presentation of Dr. Diana Zuckerman
August 4, 2025: Diana Zuckerman presented on behalf of NCHR at FDA’s first public MDUFA VI meeting of 2025. She focused on device performance goals that enhance safety, effectiveness, and transparency prior to FDA approval or clearance, and evaluating safety, effectiveness, and information for patients post-market. A major focus was on user fees being used to improve the data needed for informed consent for patients, consumers, and providers.
Read More »NCHR Comment at FDA Advisory Committee on Rexulti Used with Zoloft
July 18, 2025: We testify at FDA Advisory Committee about the lack of evidence that Rexulti combined with Zoloft treats PTSD better than Zoloft alone. Rexulti wants approval for PTSD to sell more product but it doesn’t seem to work, and its side effects include suicidal thoughts and behaviors, weight gain, diarrhea, anxiety, uncontrolled body movements, diabetes, compulsive behaviors, and stroke.
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