FDA nominee vows to tackle drug prices, shortages

PRESIDENT DONALD TRUMP’S pick to be the next commissioner of the Food and Drug Administration assured lawmakers that he will work with them to combat drug shortages and high prescription drug prices.

During his confirmation hearing last month before the Senate Health, Education, Labor and Pensions Committee, Dr. Stephen Hahn said he had personally dealt with the consequences of drug shortages in his work as a radiation oncologist.

“This is an incredibly serious issue, and I look forward to working with Congress. I think there are things we can do to help,” said Hahn, chief medical executive at the University of Texas MD Anderson Cancer Center.

He also indicated he’s willing to act indirectly to address high prescription drug prices by stimulating innovation and generic and biosimilar competition. The FDA does not have legal authority to directly intervene in drug pricing issues in the supply chain.

“Ultimately this gets to an access issue, and sometimes an access issue for our most underserved, and we have to address that,” Hahn said.

Allowing states to import prescription drugs from Canada is a top healthcare priority for Trump, but Hahn did not commit to furthering that policy.

“The American people want urgent action, and I support moving forward with action that makes sense,” Hahn said.

Sen. Tina Smith (D-Minn.) asked Hahn about the FDA’s plan to address pending applications for insulin products during the agency’s transition to classify insulin as a biologic drug beginning in March 2020, and Hahn said he would cooperate with Congress to address the issue because the transition could be a “big problem” if patient access to new treatments is delayed.

Hahn voiced general support for facilitating generic and biosimilar approvals, but gave few details. He said he would work with Sen. Susan Collins (R-Maine) to address patent gaming by biologics makers that prevents biosimilar competitors from coming to market.

Senate health committee Chair Lamar Alexander (R-Tenn.) has said he supports Hahn for FDA commissioner, but ranking Democrat Patty Murray of Washington voiced reservations, saying Hahn “has almost no government experience, almost no public record on the policy issues related to the FDA, and no experience leading an organization anywhere near as complex as the FDA.”