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Jill Wechsler is Pharm Exec's Washington Corespondent
FDA has an official new leader, following a Senate vote to confirm Stephen Hahn as the agency’s next commissioner.
FDA has an official new leader, following a Senate vote to confirm Stephen Hahn as the agency’s next commissioner. Hahn comes to FDA from the MD Anderson Cancer Center in Houston, where he was chief medical officer. Despite his lack of experience in the federal government, he benefited from broad support from dozens of patient groups and research entities, as well as a strong list of five former FDA commissioners. Regulated entities and most stakeholders affected by FDA programs usually prefer that the agency have a clear leader, as opposed to less authoritative temporary directors.
Hahn lost some support in the Senate from Democrats due to a limited commitment to taking action to against teen vaping of flavored e-cigarettes, a controversial area that has suffered from unclear administration policy. At the same time, Hahn demonstrated his political skill by indicating strong interest in numerous hot policy issues during his Senate confirmation hearings, without making clear commitments to specific actions.
Although Hahn’s role at FDA may be short-lived if there is a change in administration next November, he faces a broad range of hot-button issues that require more immediate attention. FDA is under pressure to do more to address the deadly opioid epidemic, to weigh importation of less expensive drugs from other countries, to clarify polices for marketing cannabidiol products, and for supporting the development of new breakthrough therapies filling the new drug pipeline. A main task for the commissioner is to make the case to Congress and the administration for strong funding for FDA, despite partisan hostility on Capitol Hill and administration efforts to cut federal spending. And the high cost of new cutting-edge therapies will remain a high-profile issue, raising questions about FDA vetting of the long-term benefits and risks of new treatments.