This Week at FDA: Tidmarsh saga unfolds, another batch of Commissioner’s vouchers, and more

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, FDA’s drug center is left without a leader after its director resigned over the weekend, the agency added six new drugs to its Commissioner’s National Priority Voucher (CNPV) pilot, and the agency issued warning letters to a slew of online companies for illegally marketing unapproved botulinum toxin products online.

In late September, George Tidmarsh, the head of the Center for Drug Evaluation and Research (CDER), posted on LinkedIn that the agency would be evaluating surrogate endpoints and that some companies had failed to conduct trials to demonstrate the benefits of their products on hard clinical endpoints. In particular, he singled out Aurinia Pharmaceuticals’ kidney drug Lupkynis (voclosporin). Soon thereafter, the company's stock took a 20% tumble, and while Tidmarsh deleted his post and later said that the post reflected his own opinion and not those of the agency, the damage was done.

Tidmarsh was put on administrative leave last Friday while an internal investigation of a complaint against him lodged by Kevin Tang, a San Diego-based healthcare investor and board chair of Aurinia, could be conducted. According to The New York Times, Tidmarsh reportedly resigned on Sunday, shortly before Aurinia announced that it was suing the former pharma executive. Tidmarsh has since disputed his resignation, though FDA considers him to no longer be with the agency and lists the CDER director position as vacant. The Pink Sheet reported that Richard Pazdur, director of the agency’s Oncology Center of Excellence, was offered the job of CDER director, but declined the role.

STAT News reported that Aurinia accused Tidmarsh of having a “longstanding personal vendetta against Kevin Tang." For his part, Tidmarsh said he was not aware that he had been put on administrative leave until Saturday, when he was no longer able to access his agency emails. He said he was blindsided by FDA Commissioner Marty Makary’s decision to refer the issue to the FDA's Office of Inspector General and suggested that Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER), with whom he has clashed in his brief time at the agency, was responsible for ousting him.

The Wall Street Journal also reported on the Tidmarsh saga, noting that the lawsuit accused him of soliciting a bribe and conducting a revenge campaign against Tang by attempting to tank Aurinia's stock price. The lawsuit alleges that Tidmarsh and Tang first bumped heads in 2019 when Tang asked Tidmarsh to resign as CEO of La Jolla Pharmaceutical, where Tang was the board chair. Tidmarsh's lawyer, Joseph Galda, however, denies that he tried to solicit a bribe.

STAT News reported that in light of the ongoing leadership turmoil at FDA, experts have raised concerns about what that means for the agency's reputation and effectiveness. Brian Skorney, an analyst at the investment bank Baird, said there was "total disarray and a complete lack of functional leadership," while a biotech portfolio manager said what was happening was "embarrassing," and a venture capital investor referred to the situation as “a clown show.”

Despite the concerns, Makary told attendees at the Milken Institute’s 2025 Future of Health Summit this week that the agency remains strong, in part due to a teamwork mentality that he claims did not exist before he took the helm. “The FDA is strong,” he said. “I want everybody to know the FDA is going to meet all of its targets with the user fee deadlines. We're going to meet all of our funding goals."

Six additional products were added to the Commissioner’s National Priority Voucher (CNPV) pilot program this week, bringing the total number of products that are eligible for accelerated review under the pilot to 15. The new products selected for the pilot include drugs to treat cancer, sickle cell, obesity, and medications intended to treat drug-resistant tuberculosis in children.

Drugs & biologics

The Office of Management and Budget (OMB) is reviewing a draft guidance on streamlining nonclinical safety studies for monoclonal antibodies. The agency said that it received the guidance for review on November 3.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced that Kathleen Sinninger, an investigations branch director (DIB) at FDA's Office of Medical Device and Radiological Health Operations, was unanimously elected its new chairperson at its 3 November meeting in Hong Kong.

FDA issued 18 warning letters to websites that it said were illegally marketing unapproved and misbranded versions of Botox (botulinum toxin). The agency noted that it has received reports of adverse events due to fake Botox products, including botulism symptoms.

FDA also published a warning letter to Canadian generic giant Apotex Inc. for failing to comply with current good manufacturing practices (CGMP). Specifically, the company was cited for failing to investigate potential manufacturing problems and maintain clean environments used for the manufacture of aseptic drugs.

Wisconsin-based Scientific Protein Laboratories also received a warning letter from FDA for CGMP violations. The agency stated that the company manufactures animal-derived active pharmaceutical ingredients (APIs), such as those derived from animal pancreas. However, scratches and grooves on its work surfaces suggest that its products may be contaminated, along with other concerns.

Reuters reported that FDA approved Stealth Biotherapeutics' Forzinity (elamipretide) in September as a first-of-a-kind treatment for Barth syndrome despite eight reviewers recommending against the approval. The drug is estimated to cost $800,000 annually and the reviewers did not think it had proven to be efficacious.

Reuters also reported that UniQure shares plummeted after FDA announced it did not think clinical data for its gene therapy to treat Huntington's disease was sufficient to support a marketing application. The news is not entirely a surprise, as the company was informed during a recent meeting with regulators that its data would likely be insufficient for its biologics license application (BLA).

Rhythm Pharmaceuticals announced that the FDA had granted it a three-month extension to review its supplemental New Drug Application (sNDA) for Imcivree (setmelanotide) to treat acquired hypothalamic obesity. The company's new Prescription Drug User Fee Act (PDUFA) goal date is 20 March 2026.

Medtech

The Circulatory System Devices Panel is scheduled to convene virtually on 3 December to discuss recommending the V-Wave Ventura Interatrial Shunt System. The product is a first-of-a-kind permanent implant intended to shunt blood from the left to the right atrium to improve symptoms in patients with advanced chronic heart failure.

The Digital Health Advisory Committee (DHAC) met for the second time this week to discuss the use of generative artificial intelligence (AI) in digital mental health products such as therapy chatbots. The panelists were asked about various scenarios in which patients might use such devices.

This Week at FDA: Tidmarsh saga unfolds, another batch of Commissioner’s vouchers, and more

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