On Health Policy Archives

NCHR Comments on HHS Proposed Rule Regarding Confidentiality of Substance Use Disorder (SUD) Patient Records

January 31, 2023: NCHR’s public comment criticizes the HHS plan to align privacy standards with HIPAA instead of Part 2. We are concerned that loss of privacy for patients with substance abuse disorder (SUD) could stigmatize them or discourage them from seeking treatment.

NCHR Statement on Transparency of Children’s Clinical Trials

January 24, 2023: A new report finds that 3,627 American children participated in clinical trials whose results remain hidden. This is not ‘only’ unethical – it’s illegal.

NCHR Comments on EPA’s Proposed Finding that Lead Emissions from Aircraft Engines using Leaded Fuel May Endanger Public Health

January 17, 2023: The presence of lead in aircraft engines has a significant, negative effect on public health, and we enthusiastically agree with the proposed EPA finding in support of these conclusions. These findings should be finalized as soon as possible to give EPA the authority to set aircraft emission standards for lead under section 231 of the Clean Air Act.

Patient, Consumer, and Public Health Coalition Letter to CMS on Lecanemab Approval

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.

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.