Stephen Hahn Tapped to Head FDA

US president Donald Trump has nominated Stephen Hahn as the next commissioner of the Food and Drug Administration (FDA) which will follow Congressional approval. Hahn, currently MD Anderson Cancer Center’s chief medical executive, will take over from Ned Sharpless, who had run the US regulatory agency on an interim basis following the departure of Scott Gottlieb last spring.

Sharpless, who had been recommended by Gottlieb to take the position permanently, reportedly had the support of patient advocacy groups as well as the biopharma industry. Though long seen as the leading contender, US pharma journals said he had recently been overtaken by Hahn.

The interim commissioner plans to return to the US National Cancer Institute (NCI), which he previously headed.  As the new appointment is not effective until Hahn has been approved by the US Senate, the FDA will now be led by Admiral Brett Giroir, an official at the Department of Health and Human Services (HHS).

An oncologist, Hahn previously served as a senior investigator at the NCI. According to reports, he is somewhat of a Washington outsider, having spent most of his career at academic medical centers, starting at the University of Pennsylvania in the 1990s. He took his current job at MD Anderson – which belongs to the University of Texas – in 2018.

Along with advocating quick action on rising drug costs as well as fast-track approval of biosimilars for insulin, Gottlieb, who has since returned to the pharmaceutical industry, was additionally credited with accelerating FDA approvals of generics as well as cracking down on alleged anti-competitive behavior.

A litmus test for the new chief’s leadership, the journal Fierce Pharma said, will be how he handles the repeat filing of Biogen’s troubled Alzheimer’s drug aducanumab, which the company now plans to reintroduce. Skepticism about the drug’s efficacy, is “sky high,” the journal said.