On Health Policy Archives

National Center for Health Research Public Comment on FDA Draft Guidance: Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics

February 4, 2025: In our written public comment, we urged FDA to improve its draft guidance on the accelerated approval process by requiring and enforcing timely confirmatory trials proving meaningful clinical benefit based on validated measures of overall survival and quality of life.

NCHR Public Comment on FDA Voluntary Sodium Reduction Goals

January 13, 2025: FDA has drafted new targets to reduce the high levels of sodium (salt) in Americans’ diet. NCHR urged the FDA to lower voluntary sodium targets for restaurants and food companies so that they meet the recommended maximum daily consumption. If voluntary targets aren’t met, NCHR told the FDA that targets should be mandatory in order to save lives.

Invited Panel Presentation of Dr. Diana Zuckerman at FDA OMUFA Meeting

November 20, 2024: We were invited to present at the FDA OMUFA November 2024 meeting on the OTC user fee program commitment letter. We appreciate the priority given to safety OMORs (Monograph revisions) but are concerned that the funding is focused on speed of reviews and industry access to FDA staff, not to pay for staff to conduct FDA safety reviews of OTC medications being sold for years without evidence of safety and effectiveness. OTC products will be safer if consumers and public health experts are present when negotiations take place.

Testimony of Patient, Consumer, and Public Health Coalition at Patient Engagement Device Advisory Committee Meeting

October 30, 2024: Tess Robertson Neel testified at the FDA Patient Engagement Device Advisory Panel on behalf of the Patient, Consumer, and Public Health Coalition regarding informed consent. We support the FDA’s proposed improvements, suggests a short, easy to read checklist format to improve fully informed consent, and highlights the need to enforce FDA recommendations or improve incentives for compliance.

Testimony of Laura Lytle at the FDA Patient Engagement Device Advisory Committee Meeting

October 30, 2024: NCHR’s Laura Lytle testified at the FDA Patient Engagement Device Advisory Panel meeting in support of the FDA’s proposed guidance for informed consent, but suggested 4 key areas for improvement: using a short, simple checklist to ensure that patients understand the risks; focusing on informed consent as a process not a document; simple summaries of key information; and ensuring patient privacy.