NCHR public comment tells CMS that the ColoSense multi-target mRNA stool-based colorectal cancer screening test needs better evidence to qualify for Medicare NCD coverage. The study sample included 3x the average number of smokers in the U.S. and since smoking increases the chances of colon cancer, that may have biased the results to make the test seem more accurate than it really is. To many false positives or false negatives would make the test much less useful for patients.
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 Comments on Risks and Benefits of Menopause Hormone Therapy
In response to a request for public comments, NCHR tells FDA that hormones for menopause have cancer risks and benefits, depending on when women take them and what type of hormones. Menopausal Hormone Therapy (MHT) doesn’t decrease dementia or heart disease. Vaginal hormone creams have short-term benefits but any long-term risks are unknown.
Read More »NCHR Testimony at FDA Advisory Committee Meeting on Risks of 3 Heat Sticks And Other IQOS Tobacco Products
Diana Zuckerman spoke on behalf of NCHR and CPTF at Oct 2025 FDA Tobacco Advisory Committee TPSAC meeting on whether Phillip Morris heat sticks and other IQOS products should continue to be marketed as low risk. We pointed out that these products have evidence of substantial risks in the short-term and long-term risks are likely to be greater.
Read More »Oral Testimony of Dr. Diana M. Zuckerman, Examining Policies to Enhance Seniors’ Access to Breakthrough Medical Technologies
September 18, 2025, House Energy & Commerce Committee: Dr Diana Zuckerman testified about why Medicare should not be required to pay for all Breakthrough medical devices and multi-cancer diagnostic tests unless they are proven safe, effective, reasonable, and necessary for Medicare age patients.
Read More »NCHR Comment on the Reauthorization of MDUFA
September 4, 2025: NCHR’s written public comment to FDA on MDUFA says user fees should support improvements in safety and effectiveness by paying for salaries for staff to improve premarket review, post-market surveillance and other activities, and inspections of manufacturing facilities. Industry has benefitted from MDUFA’s speedier reviews and more meetings with FDA staff, but what patients and consumers need most is safer and more effective medical devices. We deserve clear information about risks and benefits, and we can’t get that when 96+% of devices are not studied in clinical trials before being sold.
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