FDA, Politics

FDA nomination in hand, Gottlieb prepares to disentangle himself from a long list of biopharma jobs and investments

Steve Burd (R), president and CEO, Safeway, Inc. and Scott Gottlieb (L), resident fellow at American Enterprise Institute participate in a Senate Health, Education, Labor and Pensions Committee hearing on Capitol Hill, June 11, 2009 in Washington, DC. (Credit: Mark Wilson/Getty Images)


Scott Gottlieb wasn’t idle during the eight years of the Obama administration. With Democrats in the White House and Republicans out, the former agency official turned to a busy career working with quite a range of biopharma investors and companies.

Now that Gottlieb has secured Trump’s nomination as the next FDA commissioner and lined up an April 5th hearing at the Senate, he’s begun the process of unwinding those investments and business relationships in biopharma. Gottlieb filed a disclosure form yesterday with the Office of Government Ethics that will surely provide fodder for a Democratic attack during his confirmation hearings.

And there’s a lot to see.

Gottlieb’s consulting work with GlaxoSmithKline is well known, and he’s put the pharma giant on a long list of companies he will steer clear of during his first year as commissioner, recusing himself from any FDA action regarding GSK. He’s also been a board member of MedAvante, a medical device company. MedAvante owes him some compensation, he says in the ethics form, but he’ll forfeit that if it doesn’t arrive ahead of his confirmation. And if it does, he’ll recuse himself for two years.

There were board positions with Tolero and the clinical diagnostic lab CombiMatrix, which he resigned from last December. And he set up a company to complete a single consulting contract with Bristol-Myers Squibb. More consulting was done for Vertex and he wrote a series of articles for Forbes.

He also has a position with American Pathology Partners and Collective Health, but he plans to resign from those positions once he is confirmed, then recuse himself from actions related to those companies.

There are stock options in Gradalis, Glytec and Strike Bio. He’s resigned recently from positions at Gradalis and Strike, and plans to recuse himself from all three, divesting his investments in 90 days after he is confirmed as commissioner.

Gottlieb was a partner at T.R. Winston, a boutique investment bank, where he picked up investments in Cell Biotherapy, Angion Pharmaceuticals, Chanticleer Holdings and:

  • Emmaus Life Sciences
  • Inspyr Therapeutics
  • Kure
  • Lillis Energy
  • Neuralstem
  • Pharma-Bio Serv
  • Prosetta Biosciences
  • Social Reality
  • Synthesis Energy Systems
  • Tivorsan Pharmaceuticals

All of that will go when he gets the nod from lawmakers.

He will still need to resign from positions at American Enterprise Institute, the New York University School of Medicine, the Society of Hospital Medicine, the BDO Center for Healthcare Excellence and Innovation, and Daichii Sankyo US.

(Whew.)

And he’ll recuse himself from any actions involving all of them.

Chances are that the Democrats will do what it can to paint these ties as an example of Gottlieb’s too cozy relationship with an industry he plans to regulate. But with the Republicans in charge of Congress and the White House, and biopharma offering solid support for the nomination, it’s unlikely he’ll be blocked.

The industry learned to yearn for Gottlieb at the helm of the FDA precisely because his experience had to make him aware of the realities involved in developing therapies — a perspective that often seems lacking in the White House. There’s no question his portfolio took him on a global journey in biopharma that makes him a safe bet to run the agency.

But expect to hear a lot more about this in the weeks to come.


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