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.

Public Comment of National Center for Health Research Regarding Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway

March 10, 2025: National Center for Health Research supports FDA’s decision to require that a confirmatory trial is “underway” before granting accelerated approval, but the definition of underway needs to be defined stringently and clearly. In our written public comment, we recommended setting specific benchmarks and stronger oversight to ensure timely trial completion so that patients and physicians can make informed medical decisions about products approved under the accelerated program. We also state that the closer to completion the confirmatory trial is at the time of accelerated approval, the more useful the research evidence is likely to be. We also urge that no exceptions be made to the requirement.

National Center for Health Research Public Comment on FDA Draft Guidance: Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics

February 4, 2025: In our written public comment, we urged FDA to improve its draft guidance on the accelerated approval process by requiring and enforcing timely confirmatory trials proving meaningful clinical benefit based on validated measures of overall survival and quality of life.

National Center for Health Research Comment on Medicare Coverage for Transcatheter Tricuspid Valve Replacement

January 18, 2025: National Center for Health Research questioned CMS’ proposed Medicare coverage with evidence development (CED coverage) for TTVR because the device isn’t proven to save lives or reduce hospitalization. In our written public comment, we said that patients’ quality of life is also very important, but it should be evaluated in an unbiased way that does not make a device seem more beneficial than it really is.

NCHR Comment on Vitamin D, Calcium, or Combined Supplementation for the Primary Prevention of Falls and Fractures in Community-Dwelling Adults

January 21, 2025: NCHR written public comment supporting the conclusions drawn by the USPSTF and providing suggestions for improvements of their draft recommendation about Calcium, Vitamin D, and combined supplementation to prevent falls and fractures.

National Center for Health Research Comment on USPSTF Draft Recommendations on Cervical Cancer Screening

January 13, 2025: Our public comment on the USPSTF draft recommendation for cervical cancer screening emphasized the need for balanced screening strategies. We highlighted the importance of integrating cytology as a triage step after HPV-positive results, addressing follow-up care, and ensuring equitable access to minimize overtreatment and psychological distress.