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’s Testimony on the FDA’s Proposed Reclassification of Computer-Aided Devices which Provide Adjunctive Diagnostic Information about Lesions Suspicious for Melanoma from Class III Devices to Class II Devices

July 29, 2022. We do not support the proposed reclassification of the two skin lesion analyzers, MelaFind and Nevisense, from Class III to Class II. We have 2 major concerns: There is no guarantee that newly developed devices cleared through the 510(k) process would be as accurate as those currently on the market. For that reason, newly developed devices should be reviewed through the PMA process and there is a clear risk of false positive and false negative results, misuse, and device failure, and the FDA has not provided adequate evidence that these risks can be adequately mitigated with the Class II special and general controls listed in the executive summary. As described, FDA cannot ensure that there will be reasonable assurance of safety or effectiveness over the lifespan of the newly submitted devices.

NCHR Letter to Democratic Congressional Leadership on Drug Pricing Reform

July 26, 2022: We write to urge you to quickly pass a budget reconciliation bill that includes meaningful drug pricing reforms. The provisions included in the reconciliation bill to combat high drug prices are a step in the right direction and we applaud all of your hard work. There is still much to be done to lower the launch prices of new drugs, promote pricing that accurately reflects the value of a prescription, and to instill competition into a highly controlled drug market.

NCHR Comments On Dietary Supplements Subject to the Requirement for Premarket Notification

July 19, 2022. We support the proposed policy as a positive step to increase the amount of safety information we have about NDI-containing dietary supplements in the marketplace and to promote risk-based regulation. Having data is essential; reducing manufacturers’ fear of reprisal for submitting late data creates an incentive to provide that information. However, we support greater monitoring and enforcement of premarket notifications to reduce late submissions in the future, and to reduce manufacturers’ failure to submit NDIs in a timely manner.

NCHR Comments to CMS on Beta Amyloid Positron Tomography in Dementia and Neurodegenerative Disease

July 15, 2022: We agree that there is evidence that PET Aß imaging is a useful tool to support a diagnosis of Alzheimer’s Disease as part of a clinical trial protocol. However, there are conflicting data regarding its usefulness to determine the effectiveness of Alzheimer’s Disease treatment strategies.

Patient, Consumer, and Public Health Coalition Letter to Senate HELP and Energy and Commerce Committee Regarding User Fee Reauthorization Legislation

July 12, 2022: We write to urge you to expeditiously consolidate the two pieces of legislation to reauthorize the Food and Drug Administration (FDA) user fee programs for medical products. We request your consideration on reform to the accelerated approval pathway, clinical trial diversity, and new oversight of dietary supplements, cosmetics, and lab-developed diagnostic tests.