President Donald Trump's pick to be the next commissioner of the Food Drug Administration assured lawmakers on Wednesday that he will work with them to combat drug shortages and high prescription drug prices.
During his confirmation hearing 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. He told Sen. Susan Collins (R-Maine) he would work with Congress to mitigate drug shortages.
"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 told Sen. Tammy Baldwin (D-Wis.).
Allowing states to import prescription drugs from Canada is a top healthcare priority for Trump, but Hahn did not commit to furthering the policy.
"The American people want urgent action, and I support moving forward with action that makes sense," Hahn said.
The HHS secretary would ultimately decide whether to certify state importation programs, and Hahn said he planned to examine safety and security data when making any recommendations on importation.
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 Collins to address patent gaming by biologics makers that prevents biosimilar competitors from coming to market.
"I am very much in favor of transparency, and anti-competitive practices should be eliminated," Hahn said.
Hahn also said he would support expedited or increased approvals for non-opioid products and devices to treat pain with the goal of mitigating suffering while balancing the threat of opioid misuse and addiction.
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 on Wednesday, 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."
Alexander said he hopes to hold a committee vote on Hahn's nomination on Dec. 3.
