Apr 5, 2017

What to expect at Scott Gottlieb's FDA hearing

Harry Hamburg / AP

Scott Gottlieb, President Trump's nominee to run the Food and Drug Administration, is coming to the Hill this morning for his confirmation hearing. Here's a guide to what you might hear when he goes before the Senate HELP Committee:

  • 21st Century Cures: HELP Committee Chairman Lamar Alexander will press Gottlieb on his plans for implementing the legislation Congress passed last year. In his opening statement, Alexander will say that the key is "a regulatory process that is efficient and effective enough to bring safe discoveries to patients in a timely way."
  • Generic drug backlog: Gottlieb could be asked what he'd do to clear the backlog of unapproved generic drugs. Republicans like that as a way to help bring down drug prices through more competition.
  • FDA user fee agreements: Those have to be reauthorized by the end of September, and Alexander wants to get the work done before the August recess. Gottlieb could be asked for his views.
  • Industry ties: Gottlieb is well liked by health care wonks in both parties, but the biggest sticking point for Democrats is his years of financial ties to pharmaceutical companies. Ranking member Patty Murray and other Democrats are likely to ask how he'd address potential conflicts of interest.
  • Drug reimportation: Don't be surprised if Gottlieb gets a question about it. Simple reason: Trump likes it, Gottlieb hates it.
  • Anti-vaxxers: Same reason: Trump likes them, Gottlieb doesn't.

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