Industry Confidence In FDA May Hinge On CBER, CDER Leadership, Inside Health Policy

Inside Health Policy spoke with FDA & Healthcare practice group leader Michele L. Buenafe and partner Maarika L. Kimbrell about the operational and regulatory challenges facing the US Food and Drug Administration amid significant leadership turnover and staffing declines across the agency.

Michele emphasized the importance of stable leadership within FDA’s centers to support effective operations and long-term planning. “To have a center work effectively, you really need someone there that you think is going to be there long term, and can provide a level of stability and leadership for the staff and the divisions under them, so they can work effectively,” Michele said. “It’s the constant churn, I think, that is the worst thing.”

Maarika discussed how the absence of permanent leadership at the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) may complicate efforts to provide the consistency and predictability industry stakeholders seek. She noted that continuity within FDA’s product centers is critical to maintaining confidence in the agency’s regulatory approach, particularly during periods of transition. “With acting directors at CDER and CBER, and those folks being really new in those positions themselves, it strikes me as a pretty challenging formula,” Maarika said.

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