Restore Evidence-Based Leadership at the FDA

I am writing to urge you to take immediate action to restore scientific integrity and evidence-based practices at the Food and Drug Administration. Recent developments at the agency threaten public health and undermine decades of rigorous scientific standards. Last month, an internal FDA memo claimed Covid-19 vaccines caused at least 10 child deaths, relying solely on unverified reports from the Vaccine Adverse Event Reporting System. This memo was authored by Dr. Vinay Prasad, Director of the Center for Biologics Evaluation and Research, and compiled by Dr. Tracy Beth Høeg, the fourth director of the Center for Drug Evaluation and Research under this administration. Twelve former FDA commissioners sharply criticized this memo for providing no evidence beyond unverified VAERS reports, which are not designed to establish causation. Under current FDA Commissioner Dr. Marty Makary, most senior FDA staff have been replaced, and the agency has abandoned its commitment to evidence-based practices. This transformation extends across the Department of Health and Human Services. The CDC's vaccine policy panel, selected by HHS Secretary Robert F. Kennedy Jr., recently eliminated the decades-old recommendation that all newborns receive hepatitis B vaccination, despite hepatitis B being an incurable disease with deadly consequences when contracted in early infancy. The FDA's credibility depends on leadership that follows scientific evidence rather than political ideology. When the agency plans to investigate adult deaths supposedly caused by Covid vaccines using the same flawed methodology, we cannot trust the findings. If access to mRNA vaccines is restricted based on unreliable analysis, no vaccine will be safe from similar attacks. I urge you to demand congressional oversight hearings on FDA leadership appointments and to support legislation requiring that FDA leadership positions be filled by individuals with established records of evidence-based scientific practice. The health of your constituents depends on a functioning FDA that prioritizes science over politics.