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Gottlieb Wants Timely Approval Of User Fee Bill, Balanced LDT Plan

 
• By Sue Darcey

FDA Commissioner-nominee Scott Gottlieb was approved by the Senate HELP committee April 27, sending his confirmation to the full Senate. Written responses from Gottlieb to senators' questions provided in advance of the vote don't hold any big surprises, but they provide a view into priorities of the incoming official and the lawmakers, including quick user-fee reauthorization, resolving the lab-developed test oversight debate, off-label and "right-to-try" issues and post-market surveillance.

Scott Gottlieb, the Trump administration's nominee to lead FDA, told Senators charged with his confirmation that the medical device user-fee program and agency user-fee programs for prescription drugs and generics are "critically important" to FDA and that he supports their reauthorization before the clock runs out on funding for user-fee-funded reviewers by mid-July. The Senate Health, Education, Labor, and Pensions (HELP) Committee voted 14-9 in favor of confirming Gottlieb April 27, with Sens. Michael Bennet of Colorado and Sheldon Whitehouse of Rhode Island the only two Democrats supporting him.

The user-fee programs "provide significant resources to support FDA's regulatory activities related to innovative and generic medicines, biosimilars, and medical...

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