Restore Public Trust filed suit last week seeking documents about potential involvement by FDA head in his former company’s approval process

WASHINGTON — Yesterday, The New York Times editorial board published a missive questioning the FDA’s fast-track approval process, after Restore Public Trust filed a lawsuit about Acting Director Ned Sharpless’ potential involvement with his former company. Just days ago, G1 Therapeutics’ announced that its drug Triaciclib was fast-tracked by the Food and Drug Administration (FDA), by being designated breakthrough therapy while its founder Ned Sharpless served as Acting FDA Commissioner. Earlier this year, the company fast-tracked another step in the process, skipping Phase III testing altogether.

From the editorial:

Watchdogs also are questioning the agency’s recent decision to fast-track the cancer drug Trilaciclib after it failed in a Phase II clinical trial. The company behind Trilaciclib, G1 Therapeutics, was co-founded by Ned Sharpless, who is now the agency’s acting commissioner. Both the F.D.A. and G1 Therapeutics say that Mr. Sharpless divested his interests in the company before joining the agency and that he has no role in decisions pertaining to Trilaciclib. But Restore Public Trust, an anti-corruption nonprofit group, says that the agency has failed to respond to several federal records requests pertaining to the Trilaciclib decisions.

“With their founder leading the FDA, G1 Therapeutics has seen huge benefits from seeing their drug fast-tracked, skipping trial periods, and increased stock prices,” said Lizzy Price, Director of Restore Public Trust. “Americans deserve to know the extent to which FDA Commissioner Sharpless worked to assist his former company, potentially using his position to enrich himself and his friends. Our lawsuit seeks to shed light on just that.” 

Ned Sharpless helped found and once held millions in stock in the biotech company before he assumed his role as Acting Commissioner of the FDA. 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 with Sharpless as Acting FDA Commissioner, they’ve seen their lead drug candidate rapidly accelerate toward approval – twice – thanks to positive feedback from the federal agency their 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 assumes role of Action FDA Commissioner.
• April 29, 2019: G1 Therapeutics announced that they received positive feedback from meetings with the FDA over their lead drug candidate, Trilaciclib, a drug that the company estimates could bring in over $3 billion annually if approved. The feedback was so good, in fact, that they were 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 Trilaciclib was granted breakthrough therapy designation by the FDA, 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]

RPT submitted multiple records requests to the FDA regarding the matter, and has not received any of the requested documents to date of filing the lawsuit. They filed suit last week seeking the documents they requested months ago.

See the lawsuit at this link.