New leader at FDA, new philosophy?

FDA Building 2
(FDA)

Stephen Hahn is the next commissioner of the FDA. What that means for the FDA and its attitude to R&D and approval standards is unclear.

Hahn came through his Senate confirmation hearing without giving away much about his views on R&D and approval standards. That is partly a reflection of questioners focusing on other topics, most notably vaping, but is also a consequence of the low-risk approach Hahn took to the hearing, where he repeatedly avoided taking hard, definitive positions by vowing to follow the science and data.

The upshot is biopharma enters a new period of the FDA without a clear read on the direction Hahn will take the agency. There were signs after Scott Gottlieb left that the agency would take a tougher line than in the past, most notably when it rejected Sarepta Therapeutics’ Vyondys 53. However, with the FDA reversing that decision months later and Hahn’s position unclear, it is questionable whether the initial Vyondys 53 rejection will be seen as a blip or a harbinger of a new approach.

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Events in the new year, notably Biogen’s aducanumab filing, should start to provide some answers. However, the impact of whatever changes Hahn tries to enact may be short-lived given the potential for the Democrats to win the 2020 election and install a new leader at the FDA.

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