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.
Read More »On Health Policy
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.
Read More »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.
Read More »NCHR Public Comment to CDC Safety Office on COVID Vaccine Research and Communications
October 11, 2024: We presented our public comment at the NASEM Review of CDC COVID-19 Vaccine Safety Research and Communications Meeting 3 on how CDC could improve research and communications regarding COVID-19 vaccines. We said CDC needs to be clear on what is known and not known and needs to quantify what is known about adverse events and complications from vaccines.
Read More »NCHR Public Comment on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies
September 26, 2024: NCHR appreciates the improvements made in the 2024 FDA draft guidance for Diversity Action Plans but the draft lacks incentives to encourage companies to comply. The indication and label should reflect the evidence for sex, race, ethnicity, and ages of patients studied. Approval should only be for patients for whom clear evidence of safety and effectiveness was provided.
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