September 7, 2023: We testified that FDA’s plan to reclassify hepatitis B (HBV) assays from high risk (Class III) to moderate risk (Class II) would mean lack of evidence of accuracy. Why do that when there are already accurate assays available? Lowering the standards would harm patients by resulting in inappropriate treatments.
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 the FDA Proposed Guidance Regarding the Registration and Listing of Cosmetic Product Facilities and Products
September 7, 2023: NCHR provided comments on the FDA guidance regarding the registration and listing of cosmetic product facilities and products required in the Modernization of Cosmetics Regulation Act of 2022. We support these requirements and provide recommendations to improve the guidance.
Read More »NCHR Comments on The E6(R3) Guideline for Good Clinical Practice and International Council for Harmonisation Draft Guidance
September 5, 2023: We support the overall goals of the Good Clinical Practices International Council Harmonisation guidance. But we recommend strengthening diversity criteria and providing objective trial oversight while leveraging stakeholder engagement committees to improve study quality and participant safety.
Read More »NCHR Comments on the CMS Notice on Transitional Coverage for Emerging Technologies (TCET).
August 28, 2023: We support the overall goals of the TCET program, but we see an enormous disconnect between the types of evidence that FDA requires for breakthrough devices and the CED standards that CMS requires for coverage.
Read More »NCHR Comments on the Food and Drug Administration In-Home Disposal Systems for Opioid Analgesics
August 28, 2023 The FDA is assessing whether in-home disposal products can reduce opioid nonmedical use and overdose. We recommend user-friendly, accessible in-home disposal systems that rely on deactivation rather than incineration.
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