Advocacy groups are concerned that Acting Commissioner Janet Woodcock will become FDA Commissioner under the Biden administration, stating that she has contributed to the opioid epidemic. She also overruled a recommendation against dubious Duchenne Muscular Dystrophy drug eteplirsen, a decision that had far-reaching impacts for the FDA. The alternative candidate is Joshua Sharfstein of Johns Hopkins and former FDA principal deputy commissioner. Supporters of Sharfstein note his dedication to serving minority populations, his goal of improving transparency at the FDA, and his ability to work with biopharma companies while maintaining confidence in the FDA.
Daniel Carpenter of Harvard University and Gregg Gonsalves remark, “As a weary and uncertain America faces the likelihood of needing continual rollout of new coronavirus treatments in the years to come, the stakes for President Biden’s choice for FDA leadership could not be higher. A public health leader with top-level FDA experience, a distinguished service record in state and local government, and a commitment for procedural integrity is available in Dr. Joshua Sharfstein.” Read more here.
(Ed Silverman, STAT News, 1/27/21; Carpenter & Gonsalves STAT News 1/24/21)