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 »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.
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.
Read More »NCHR Testimony regarding Front-of-Package Nutrition Information Labeling
July 15, 2025: NCHR submitted written comments to the U.S. Food and Drug Administration in support of the proposed rule on front-of-package nutrition labeling, recommending stronger, clearer labeling requirements, especially for young children. They suggested additional testing to ensure consumers understand and benefit from the labels, including those with limited literacy or English proficiency.
Read More »PDUFA VIII Statement of Dr. Amanda Berhaupt, Health Policy Director of NCHR
July 14, 2025: NCHR presentation at PDUFA July 2025 user fee meeting focuses on including patients and consumers in negotiations with FDA and industry and adding metrics to ensure post-market safety and meaningful clinical outcomes for prescription drugs.
Read More »