January 13, 2025: FDA has drafted new targets to reduce the high levels of sodium (salt) in Americans’ diet. NCHR urged the FDA to lower voluntary sodium targets for restaurants and food companies so that they meet the recommended maximum daily consumption. If voluntary targets aren’t met, NCHR told the FDA that targets should be mandatory in order to save lives.
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 Regarding Device Trial Participation Snapshots
January 13, 2025: In response to FDA’s draft of medical device Snapshots, NCHR urged FDA to add more information about risks and benefits in wording that is easy to understand. The information should also quantify the risks and benefits and explain the implications of the strengths and weaknesses of the evidence. The SnapShots should be brief but should include the information that helps patients and physicians make important decisions about whether the device has benefits that outweigh the risks for patients.
Read More »December 12, 2024: Testimony of Dr. Siddiqui at FDA Vaccines and Related Biological Products Advisory Committee Meeting
December 12, 2024: NCHR Postdoctoral fellow Dr. Saman Siddiqui testified at the FDA Advisory Committee meeting about the need for better clinical trials of RSV vaccines for infants and toddlers because of serious risks in that age group.
Read More »Invited Panel Presentation of Dr. Diana Zuckerman at FDA OMUFA Meeting
November 20, 2024: We were invited to present at the FDA OMUFA November 2024 meeting on the OTC user fee program commitment letter. We appreciate the priority given to safety OMORs (Monograph revisions) but are concerned that the funding is focused on speed of reviews and industry access to FDA staff, not to pay for staff to conduct FDA safety reviews of OTC medications being sold for years without evidence of safety and effectiveness. OTC products will be safer if consumers and public health experts are present when negotiations take place.
Read More »Testimony of Dr. Zuckerman at FDA Joint Advisory Committees Meeting on Clozapine REMS for Neutropenia
November 19, 2024: We testified at the FDA Advisory Committees joint meeting that the REMS to prevent neutropenia in Clozapine patients is essential to save lives, but that some barriers to patient access should be reduced. Clozapine can cause a dangerous reduction in an important type of white blood cells, making patients vulnerable to infections that require hospitalization and can be fatal.
Read More »