February 22, 2022: We strongly urge the FDA to hold firm in the demands to strengthen pre- and post-market safety performance measures and surveillance as part of the MDUFA Commitment Letter as you enter into final negotiations with industry. MDUFA performance goals should include metrics regarding safety, and not just speed of review.
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.
Testimony of Dr. Diana Zuckerman About IV Tramadol Before FDA Advisory Committee
February 15, 2022: NCHR testifies against the opioid, tramadol, administered by IV to the FDA Advisory Committee.
Read More »NCHR’s Comments on USPSTF’s Draft Recommendation Statement on Behavioral Counseling to Reduce Cardiovascular Disease in Adults Without Known Risk Factors
February 14, 2022: Given the lack of evidence of a more meaningful benefit, we support the “C” grade recommendation that clinicians make decisions for these individual patients about whether to offer or refer them to behavioral counseling.
Read More »Public Comment PDUFA VII Commitment Letter (Docket #FDA-2021-N-0891) From the National Center for Health Research
October 28, 2021: NCHR comments on the proposed PDUFA VII Commitment Letter from the FDA.
Read More »Patient, Consumer, and Public Health Coalition Comment on CMS’s Proposed Decision Memo on Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease
February 10, 2022: As members of the Patient, Consumer, and Public Health Coalition, we strongly support the CMS proposed decision to limit the coverage of these drugs to patients participating in clinical trials, because it will provide the evidence needed regarding safety and effectiveness for the Medicare population.
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