Ex-FDA Head Gottlieb Warns on Politicization Threatening Scientific Credibility

Former FDA commissioner Scott Gottlieb is urging federal health officials to restore scientific leadership at the agency's medical product centers, arguing that recent political appointments and workforce losses have weakened the agency’s effectiveness and credibility.

In a commentary published in JAMA Health Forum, Gottlieb said FDA has experienced significant disruption over the past year, with staff departures and layoffs damaging institutional expertise across key review divisions. He cited the agency's Oncology Center of Excellence, where roughly half of the clinical review staff have reportedly left since early 2025.

Gottlieb argued that leadership at FDA's drug and biologics review centers should remain in the hands of experienced scientific and clinical experts rather than political appointees. While elected officials and administration leaders should set broad policy priorities, he said regulatory decisions involving individual products must remain grounded in scientific judgment to preserve public trust and regulatory credibility.

The former commissioner contended that efforts to exert greater political control over FDA review centers can ultimately undermine policy goals by making regulatory decisions appear ideological rather than evidence-based. He warned that politicizing scientific review functions could weaken FDA's standing as the world's leading drug regulator at a time when other nations, including China, are expanding their regulatory influence.

Gottlieb also pointed to recent leadership turnover at FDA and HHS as an opportunity to reassess how the agency is governed. He called for a return to FDA's traditional model in which career experts lead scientific review activities while political leadership focuses on broader regulatory policy.