Hahn Confirmed by Senate to Lead FDA, but Where Does He Stand on Biosimilars?

December 13, 2019
Kelly Davio

On Thursday, the Senate voted to confirm Stephen Hahn, MD, FASTRO, chief medical executive at the University of Texas MD Anderson Cancer Center, as the 24th commissioner of the FDA.

On Thursday, the Senate voted to confirm Stephen Hahn, MD, FASTRO, chief medical executive at the University of Texas MD Anderson Cancer Center, as the 24th commissioner of the FDA. The final vote was 72 to 18.

Among those voting against confirmation were Senators Kristen Gillibrand, D-New York; Ron Wyden, D-Oregon; and Chuck Schumer, D-New York.

Hahn received a relatively speedy confirmation to lead the agency, having been nominated by President Donald Trump just last month. During the past few weeks, however, little information about has emerged about Hahn’s strategies for leading the FDA, or about his position on fostering the US market for biosimilars.

During the confirmation process, speaking before the Senate Committee on Health, Education, Labor and Pensions, Hahn said that the FDA must encourage innovation and foster competition in order to have access to “a continuously improving universe of treatments,” and pledged to work in a bipartisan manner to serve the public.

He added that Americans want action on the problem of drug pricing, voiced support for generics and biosimilars in general, and indicated that he would work with Congress to address any delays in access to treatments that arise from the upcoming March 2020 transition of insulins to regulation as biologics.

The Biosimilars Forum congratulated Hahn on his confirmation, saying in a statement that it hopes to work with him to “translate urgency into action” on the matter of developing the biosimilars market.

However, given the robust support that biosimilars enjoyed under former commissioner Scott Gottlieb, MD, stakeholders may be left wondering whether Hahn will continue to make the FDA a vocal supporter of biosimilar competition.

During his tenure at the agency, Gottlieb oversaw the release of the Biosimilar Action Plan, called on drug makers to “end the shenanigans” that block biosimilars (including the misuse of Risk Evaluation and Mitigation Strategy programs), and took aim at pay-for-delay tactics as well as rebate and contracting provisions, all of which he said were making the biosimilars market unstable.

Even after Ned Sharpless, MD, took up his post as acting commissioner after Gottlieb’s resignation, biosimilars saw steps forward, with the approval of new biosimilars and the release of the agency’s long-awaited final guidance on interchangeability.

Additionally when Admiral Brett Giroir stepped in to helm the agency between Sharpless’ departure and Hahn’s confirmation, the agency released its momentous draft guidance on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins.

That guidance, which indicated that interchangeable insulins will not generally require switching studies, represented a substantial shift in the agency’s thinking; some experts told The Center for Biosimilars® that Giror’s brief tenure in the post may have made him an ideal person to try out new ideas that could accelerate biosimilar availability before the arrival of the new commissioner whose views on biosimilars are as yet unclear to stakeholders.