January 6, 2023: We applaud your National Coverage Determination that made the wise decision to limit coverage of this class of drugs solely to patients participating in clinical trials following the approval of aducanamab (Aduhelm) by the FDA. The FDA approved Biogen and Eisai’s lecanemab today, and we urge you to hold firm to your decision to prioritize patient safety and the scientific credibility of CMS’s coverage decisions.
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NCHR Comment on FDA Proposed Rule on the Protection of Human Subjects and Institutional Review Boards(IRB)
December 28, 2022: NCHR public comments on FDA’s proposed rule supports a single IRB for all U.S. centers in multi-center clinical trials and greater diversity among IRB members. We urge the FDA to require more explicit improvements to address known weaknesses in oral and written informed consent procedures and address demographic differences in efficacy and safety of treatments studied clinical trials.
Read More »NCHR Comments on EPA’s Draft for Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
December 27, 2022: NCHR public comments on EPA’s proposed draft supports the need for recordkeeping and reporting as they are vital steps toward managing perfluoroalkyl and polyfluoroalkyl substances (PFAS). However, there are accountability loopholes identified in this proposed draft that could allow manufacturers to take advantage of the system, ie. making it optional to register an unknown chemical with a CASRN or other identifier and not required. It is for reasons like this that we believe the draft does not go far enough.
Read More »NCHR Comments on FDA Ethical Considerations for Clinical Investigations of Medical Products Involving Children
December 27, 2022: We address suggestions of how to improve this guidance to promote safety and efficacy in clinical investigations of medical products involving children. Many new medical products that are used by children are never actually tested on them or approved for them prior to entering the market. Many children are either left with no treatment options or given products “off label” that have not been tested for safety, effectiveness, or dosage requirements in patients of their age, size, or weight.
Read More »NCHR Comments on HHS and FDA’s Request for Information on Ortho-phthalates for Food Contact Use
December 27, 2022: NCHR strongly urges the FDA to ban the remaining phthalates from materials that have contact with food, and to rigorously enforce this ban. Phthalates are endocrine disrupting chemicals that have potential adverse effects for children and adults, such as fertility issues and obesity, and can be detrimental even at low levels of exposure. These toxins are found in many items used in food preparation, contact, and packaging, and can leach out of these products where they can be consumed or inhaled.
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