Hahn Wins Senate Backing to Become Trump’s Next FDA Chief

December 12, 2019, 7:21 PM UTC

U.S. senators voted overwhelmingly to back President Donald Trump’s nominee to lead the Food and Drug Administration, clearing Stephen Hahn to steer the agency as it deals with pressing health issues including generic-drug safety and vaping regulations.

The Texas oncologist sailed through a Senate Health, Education, Labor, and Pensions committee vote Dec. 3, and the final vote by the full Senate on Thursday was 72 to 18.

Hahn, 59, will likely pick up where predecessor Scott Gottlieb left off, tackling issues such as drug shortages, increasing generic approvals and encouraging alternatives to traditional opioids for pain management. Hahn said during his confirmation hearings he supports the agency’s current initiatives, including efforts to stem opioid abuse, lower barriers for companies to make copies of expensive drugs called biologics and increase transparency with lawmakers.

It isn’t clear where Hahn will land on regulations to pull popular vape flavors from the market. The nominee told the HELP Committee he’d use “science and data” to decide on actions to curb high teen vaping rates. His refusal to commit to cutting flavors from the e-cigarette market cost him the support of some senators, including the Democratic committee leader from Washington state, Patty Murray.

Lawmakers and policy insiders will also watch to see how Hahn handles drug importation efforts and the March 2020 transition to classify certain drugs, including insulin, as biologics. Gottlieb has said the March transition could lead to cheaper versions of insulin, but Hahn is concerned that might delay pending applications from drugmakers.

Hahn said science and data also would inform any actions on drug importation and stressed the need to keep the FDA’s “gold standard” for drug manufacturing.

House lawmakers have grilled the FDA twice in recent months about lagging inspections for foreign drug facilities. The most recent congressional probe followed a damning audit that showed foreign inspections have decreased in the past two years and that data integrity continues to be an issue with facilities in countries like China and India.

Hahn will face pressure to improve drug supply safety and staff up the agency as it struggles to keep up with competing jobs in the private sector that pay more and have less bureaucracy in the hiring process.

The agency didn’t provide a timeline for when Hahn will take over his duties as commissioner. Brett Giroir, a Health and Human Services official, has been acting FDA commissioner since early November.

To contact the reporter on this story:
Jacquie Lee in Arlington at jlee2343@bloomberg.net

To contact the editors responsible for this story:
Fawn Johnson at fjohnson36@bloomberg.net

Timothy Annett, Mark Schoifet

© 2019 Bloomberg L.P. All rights reserved. Used with permission.

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