Conflicts of Interest May Have Cost Sharpless FDA Nomination

WASHINGTON – After a turbulent run as acting commissioner of the Food and Drug Administration (FDA), Ned Sharpless will be passed over for the permanent role today following accusations of misusing his position to boost drug industry profit margins. Trump will reportedly instead tap Dr. Stephen M. Hahn, a Texas oncologist and chief medical executive at M.D. Anderson Cancer Center, for the role. Restore Public Trust released the following statement in response:

“Acting Commissioner Sharpless will not become permanent Commissioner Sharpless because his conflicts of interest run too deep,” said Lizzy Price, Director of Restore Public Trust. “Americans’ trust in FDA-approved drugs should not waver based on who sits at the head of the agency. Sharpless’ failure to address allegations that he helped unfairly fast-track drugs his former company developed through the FDA approvals process raises serious ethical concerns about his remaining ties to Big Pharma and his leadership at the FDA more broadly. While Sharpless will not receive a permanent role as FDA head, Congress must still investigate his involvement in fast-tracking drug approvals. Americans’ faith in the FDA is dependent on it.”

See our questions for expected nominee Dr. Hahn here.

Sharpless co-founded G1 Therapeutics, a company that develops cancer drugs, and owned at least $6 million in assets tied up in the company. In August, following the news the same G1 Therapeutics drug was fast-tracked a second time through the federal approvals process, Restore Public Trust filed suit in federal court to force disclosure of documents regarding Sharpless’ contract with the company he founded. 

In the eleven years since its founding in 2008, G1 Therapeutics has never commercialized a single drug or made a single dollar in commercial revenue. But in five months into Sharpless’ tenure as acting FDA commissioner, the company has seen its lead drug candidate rapidly accelerate toward approval — twice — thanks to positive feedback from the federal agency its founder now leads.

  • December 2018: G1’s stock plummeted after its cancer drug Trilaciclib failed to outperform placebo in a phase 2 clinical trial.
  • March 12, 2019: G1 Therapeutics stock closed at $16.70 per share. [Yahoo Finance]
  • April 5, 2019: Sharpless assumed the role of acting FDA commissioner.
  • April 29, 2019: G1 Therapeutics announced that it received positive feedback from meetings with the FDA over its lead drug candidate, Trilaciclib — a drug the company estimates could bring in over $3 billion annually if approved. The feedback was so good, in fact, that the company was going to take the rare step of skipping the onerous and expensive Phase 3 testing of the drug altogether and start the FDA approval process.
  • May 10, 2019: G1 Therapeutics stock closed at $25.02 per share. [Yahoo Finance]
  • August 7, 2019: G1 Therapeutics announced that the FDA granted Trilaciclib breakthrough therapy designation, further expediting the development and review of the drug. Just one day after the most recent news, G1 Therapeutics stock rose over 26%.
  • August 8, 2019: G1 Therapeutics stock closed at $29.76 per share. [Yahoo Finance]
  • September 10, 2019: G1 Therapeutics stock closed at $40.00 per share, an 11% increase, after the organization announced a meeting with the FDA to discuss its cancer drug, Trilaciclib. [Yahoo Finance]


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