Former FDA Official Howard Sklamberg Comments on FDA Leadership Changes in Pink Sheet

Howard Sklamberg, Life Sciences & Healthcare Regulatory partner and former Deputy Commissioner for Global Regulatory Operations and Policy at the U.S. Food and Drug Administration (FDA), was quoted in the Pink Sheet article, “Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy.” The article discussed the implications of Vinay Prasad’s reappointment as director of the agency’s Center for Biologics Evaluation and Research, and broader leadership and regulatory transitions at the FDA.

Reflecting on Prasad’s return to the FDA, Sklamberg noted that “when you zig and zag and switch senior leaders frequently it makes it very hard to develop policy.” He emphasized that longstanding leadership has historically contributed to the FDA’s reputation as the “gold standard,” and cautioned that frequent turnover puts that stability and the agency’s effectiveness at risk.

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