Top FDA official Tidmarsh resigns after comments on kidney drug, HHS probe

[Headquarters of US Food and Drug Administration (FDA)]
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George Tidmarsh has lost his job as director of the U.S. FDA's Center for Drug Evaluation and Research amid accusations that he leveled false statements against a Canadian drugmaker and disparaged one of the company's drugs.

Several news outlets reported that Tidmarsh drew the ire of Aurinia Pharmaceuticals (AUPH [https://seekingalpha.com/symbol/AUPH]) for comments he recently made on their lupus nephritis drug, Lupkynis (voclosporin). In a now deleted post on X, he wrote [https://seekingalpha.com/news/4500115-aurinia-responds-fda-officials-comment-lead-drug] that although the drug was approved based on surrogate endpoints, it has "significant toxicity," adding, "for some diseases, such as lupus nephritis, companies have not run trials to demonstrate a benefit on hard clinical endpoints like progression to end-stage renal disease."

The comments led to Aurinia shares closing down ~3% on Oct. 29.

_The Wall Street Journal _reported that on Sunday evening, Aurinia filed [https://www.wsj.com/health/pharma/fda-official-steps-down-sued-by-drugmaker-76fa9ce4] a lawsuit in a Maryland federal court accusing Tidmarsh of making false statements and soliciting a bribe to get back at a former colleague, Kevin Tang, who is now chair of Aurinia.

In 2019, Tang was chair of La Jolla Pharmaceutical Co., acquired by Innoviva (INVA [https://seekingalpha.com/symbol/INVA]) in 2022, and Tidmarsh was CEO when Tang apparently asked Tidmarsh to step down, which he did [https://www.biospace.com/la-jolla-pharmaceutical-company-announces-management-transition].

Tang also filed a complaint with the FDA about the X post, which has led to an HHS Inspector General investigation.

An HHS spokeswoman told the _Journal_ that Tidmarsh was placed on administrative leave on Oct. 31 and resigned Sunday morning.

_The New York Times_ reported that he was put on leave due to the inspector general probe into the accusations. However, Tidmarsh told the newspaper that he had not resigned and was still on leave.

Tismarsh told the newspaper that working at the FDA was a "toxic environment," which he pinned on the agency's chief medical and science officer, Vinay Prasad.

He also questioned the new FDA Commissioner’s National Priority Review Voucher program, announced in October, which aims [https://seekingalpha.com/news/4505159-achieve-disc-among-winners-fda-national-priority-vouchers?source=feed_symbol_REGN] to speed up review times for drugs deemed to have significant unmet need.

"The effort was going to basically change the entire paradigm of the legal underpinnings of drug approvals that have for decades supported the actions on the safety and effectiveness of drugs," Tidmarsh said. "There was insufficient legal support for what they wanted to do, and so I didn’t agree."

MORE ON AURINIA PHARMA

* Aurinia Pharmaceuticals: Lupkynis Growth And AUR200 Pipeline Justify Buy Rating [https://seekingalpha.com/article/4832182-aurinia-pharmaceuticals-lupkynis-growth-and-aur200-pipeline-justify-buy-rating]
* Aurinia Pharma: The Easiest Money May Have Been Made (Rating Downgrade) [https://seekingalpha.com/article/4809769-aurinia-pharma-the-easiest-money-may-have-been-made-rating-downgrade]
* Aurinia responds after top FDA official’s comment on lead drug [https://seekingalpha.com/news/4500115-aurinia-responds-fda-officials-comment-lead-drug]
* Seeking Alpha’s Quant Rating on Aurinia Pharma [https://seekingalpha.com/symbol/AUPH/ratings/quant-ratings]
* Historical earnings data for Aurinia Pharma [https://seekingalpha.com/symbol/AUPH/earnings]