On November 28, Vinay Prasad, chief of the Center for Biologics Evaluation and Research, issued a memo to the Food and Drug Administration (FDA) announcing changes to vaccine frameworks in response to ten deaths allegedly linked to COVID-19 vaccinations. According to Dorit Reiss, professor at UC Law San Francisco, "It was as if he was issuing a decree 'by fiat.'" Reiss noted that Prasad did not share data or consult FDA experts and did not follow standard bureaucratic procedures.
Large government organizations typically require multiple levels of bureaucracy for significant changes. This structure is intended to ensure coherent administrative processes and strategic implementation. However, the FDA has seen nearly 90% turnover among senior-level directors over the past year, leading to instability within the agency.
Regulatory expert Steven Grossman wrote for BioSpace: "The agency’s history and culture enshrine predictability and expertise as core values. In my opinion, those values are antithetical to Trump’s norm-breaking approach to policymaking." The loss of experienced leadership has contributed to uncertainty for those relying on the FDA.
This trend extends beyond the FDA. At the Centers for Disease Control and Prevention (CDC), members of the Advisory Committee on Immunization Practices have expressed confusion about voting procedures, leading to delayed decisions. Former CDC chief Susan Monarez was dismissed after being told by Health Secretary Robert F. Kennedy Jr. to pre-approve recommendations from ACIP—an example of bureaucratic overreach.
The FDA's Center for Drug Evaluation and Research (CDER) has experienced high turnover with five different leaders this year alone. George Tidmarsh left after publicly criticizing a company on LinkedIn, while Richard Pazdur retired three weeks into his role as CDER director amid reports that Commissioner Marty Makary was intervening in personnel matters despite previous assurances.
Communication practices at these agencies have also shifted away from established protocols. Announcements about new policies have been made through social media or media interviews rather than formal guidance documents with stakeholder input. This change has caused confusion among companies and patients who rely on predictable regulatory processes.
Companies such as Sarepta and Capricor learned about key regulatory decisions from news outlets instead of directly from the FDA—a departure from standard notification practices (source). The FDA maintains it remains committed to informing companies before making information public.
Recent reversals in regulatory decisions have impacted several biopharma firms including Biohaven, uniQure, Capricor, and others (source). Evan Seigerman of BMO Capital Markets commented at a BioSpace event regarding Replimmune’s advanced melanoma candidate RP1: “It throws everything into a tailspin.” These reversals may signal more restrictive regulatory approaches in the future.
Additionally, drugs already approved may face reevaluation without clear explanations given publicly; recent examples include anti-RSV antibodies produced by Merck, Sanofi, and AstraZeneca.
While bureaucracy can be challenging, it serves an important purpose by ensuring informed decision-making and transparent communication. The absence of such processes risks undermining both industry stability and patient trust.
