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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #37

Stephen Hahn selected to become the next US FDA Commissioner

President Donald Trump has nominated Stephen Hahn as the next US FDA commissioner. Hahn, a radiation oncologist is currently chief medical executive of the University of Texas MD Anderson Cancer Center in Houston since 2018, was the preferred pick – rather than acting Ned Sharpless – of Department of Health and Human Services (HHS) Secretary Alex Azar. Before been officially appointed Stephen Hahn needs to be confirmed by the US Senate. Hahn’s profile and background as a senior investigator at the National Cancer Institute (NCI) is rather unusual when compared with his predecessors: Scott Gottlieb, Margaret Hamburg and Robert Califf who each had public health experience from time spent at the HHS and FDA. In contrast Hahn has spent most of his career at academic institutions, starting out at the University of Pennsylvania in the 1990’s before joining MD Anderson about 5 years ago.

Other unusual moves have been announced.

Acting FDA commissioner Ned Sharpless, who had been strongly supported by Scott Gottlieb and many lobbying groups, returns to his former role at the NCI, in fact today, as this was the deadline for his acting role, and he cannot serve for any longer in that position.

Admiral Brett Giroir, an official of the Department of HHS will be the acting commissioner until Hahn’s appointment by the Senate will be confirmed.

Several hot topics will be on Hahn’s plate upon arrival at the job: the handling by the agency of vaping and the two recently reported deaths and the assessment of Biogen’s aducanumab filing, for the treatment of Alzheimer’s disease. The surprising “resuscitation” of the drug after a failed futility analysis has been received by scepticism by some, but Biogen said that the agency was apparently satisfied by the attempt to file as more data from the ENGAGE and EMERGE studies will become available in December.

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