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.

Statement of Dr. Diana Zuckerman before the FDA Advisory Committees on Safety and Risk Management and Anesthetic and Analgesic Drug Products On Behalf of the National Center for Health Research

May 5, 2025: NCHR president Dr. Diana Zuckerman testified at the FDA joint meeting of the Safety and Risk Management and Anesthetic and Analgesic Drugs Advisory Committee to discuss the OPC industry consortium new research results on the safety of extended release and long-term opioids. We criticized the biased definition of opioid use disorder (OUD) created by the industry consortium, which resulted in making long-term opioid use seem safer than it really is. We also criticized the labeling on all opioids for not accurately stating that opioids are not proven safe or effective for long-term use.

NCHR Testimony at D.C. Council Public Oversight Roundtable on Environmental and Safety Hazards on DPR Properties

May 05, 2025: NCHR’s Tess Robertson-Neel testified at a D.C. Council roundtable about environmental and safety hazards in DC parks and playgrounds. We highlighted concerns about heat-related injuries, other injuries and serious harms, and the presence of lead, PFAS and other harmful chemicals and metals in artificial turf and playground surfaces. Artificial turf and rubber playground surfaces have serious risks that can endanger children’s health. We urged the D.C. council to invest in safer, healthier alternatives.

NCHR Comment on Medicare Coverage for Tricuspid Valve Transcatheter Edge-to-Edge Repair

May 2, 2025: The National Center for Health Research questions CMS’s proposed Coverage with Evidence Development for Tricuspid Valve Transcatheter Edge-to-Edge Repair (T-TEER), because it is not proven to save lives or reduce overall hospitalizations. We are also concerned about adverse events and problems with the research evidence used to support approval and coverage.

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.