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United States. Food and Drug Administration

Top FDA Regulator Resigns Amid Scrutiny over Comments Criticizing Canadian Pharmaceutical Company

Strategic Insights

— 2 min read

Top drug regulator George Tidmarsh resigned Sunday from the Food and Drug Administration, amid scrutiny over his comments criticizing a treatment made by Aurinia Pharmaceuticals. Tidmarsh had been placed on administrative leave Friday after concerns were raised about his personal conduct. He had been at the FDA since July, overseeing the Center for Drug Evaluation and Research, which regulates over-the-counter and prescription drugs.

The concerns surrounding Tidmarsh's resignation stem from his LinkedIn post in September, in which he criticized the FDA-approved drug voclosporin as having "significant toxicity." Aurinia Pharmaceuticals, the maker of the medication, filed a lawsuit against Tidmarsh, alleging that his comments were part of a "long-standing personal vendetta" against the company's board chairman. The lawsuit also claims that Tidmarsh attempted to extort the chairman and pushed the FDA to remove a top-selling product made by American Laboratories from the market.

Key Takeaways:

  • Tidmarsh resigned as director of the Center for Drug Evaluation and Research, a top role at the FDA, after being placed on administrative leave.
  • Aurinia Pharmaceuticals filed a lawsuit against Tidmarsh, alleging that his comments criticizing their treatment made up a "long-standing personal vendetta" against the company's board chairman.
  • The lawsuit also claims that Tidmarsh attempted to extort the chairman and pushed the FDA to remove a top-selling product from the market.
  • Tidmarsh's comments to the New York Times were related to a new program aimed at quickly approving some drugs, of which he believed there was "insufficient legal support."
  • The concerns about Tidmarsh's personal conduct were related to a September LinkedIn post in which he criticized the FDA-approved drug voclosporin as having "significant toxicity."
  • Aurinia Pharmaceuticals' treatment, voclosporin, is used to treat a type of lupus affecting the kidneys.
  • Tidmarsh previously worked as CEO of a different company, which was pushed out by the current chairman of Aurinia Pharmaceuticals, Kevin Tang, in 2019.

Statistics:

  • September: Date of Tidmarsh's LinkedIn post criticizing the FDA-approved drug voclosporin.
  • July: Month Tidmarsh joined the FDA as director of the Center for Drug Evaluation and Research.
  • June: Month the FDA announced a new program to expedite drug approval decisions, championed by FDA Commissioner Marty Makary.
  • October 16: Date the FDA announced the first nine vouchers for national priorities, including for Type I diabetes, nicotine vaping addiction, cancer, deafness, blindness and a rare blood disorder.

Sources:

  • A top drug regulator at the Food and Drug Administration resigned Sunday, officials said, amid scrutiny over his comments criticizing a treatment made by a Canadian pharmaceutical company.
  • Rachel Roubein, "Top FDA Regulator Resigns Amid Scrutiny Over Comments Criticizing Canadian Pharmaceutical Company," The Washington Post, Sunday.
  • Emily Hilliard, spokeswoman for the Department of Health and Human Services, statement on Tidmarsh's resignation.
  • New York Times, interview with George Tidmarsh, Sunday.
  • Aurinia Pharmaceuticals lawsuit against Tidmarsh, filed Sunday.

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