CDER head Tidmarsh 'on leave' and is sued by drugmaker

The head of the FDA's drug unit, George Tidmarsh, has reportedly been placed on administrative leave while an investigation is carried out into his personal conduct.

A report in Stat says Tidmarsh has been accused of using his regulatory position to financially harm Kevin Tang – one of his former business associates – and Aurinia Pharma, a company in which Tang is an investor.

Tidmarsh, who was named as director of the Center for Drug Evaluation and Research (CDER) in July, told ABC in an interview last night that he believed the probe into his conduct was prompted by concerns he raised about a new fast-track programme for the rapid approval of some drugs.

He also said he was in the line of fire after speaking out against Vinay Prasad, his counterpart at the Center for Biologics Evaluation and Research (CBER) and the FDA's chief medical and scientific officer. Tidmarsh briefly replaced Prasad as acting head of CBER after Prasad stepped down from the role in August, only to be reinstated just a few days later.

It's been reported that Tidmarsh has offered his resignation, which has been accepted, but that has not been confirmed at the time of writing.

Lawsuit filed

The pressure on Tidmarsh only ramped up yesterday after it emerged that a lawsuit had been filed by Aurinia against Tidmarsh. A copy of the complaint secured by pharmaphorum shows that Aurinia is accusing him of "false and defamatory statements" against the company and main product Lupkynis (voclosporin), used to treat lupus nephritis.

It claims that Tidmarsh's statements were "the products of his longstanding personal vendetta" against Tang, who currently serves as Aurinia's chair and also manages Tang Capital, an investment fund that is Aurinia's largest shareholder.

According to the complaint, Tidmarsh's issues with Tang date back several years to 2019. At that time, Tidmarsh was serving as president and chief executive of La Jolla Pharma, while Tang was chairman of the board and, in November of that year, Tang asked him to resign from that role, as well as positions at two other companies (American Laboratories and Odonate Therapeutics).

The lawsuit claims that Tidmarsh threatened retribution against Tang over the next few years in texts and emails, and in his accession to the FDA, he was finally in a position to act on those threats.

It further alleges that Tidmarsh pushed the FDA to remove American Labs' top-selling desiccated thyroid extract (DTE) products from the market just weeks after taking on the CDER role, asked Tang agree to American Labs making "payments until the year 2044 into a [...] Tidmarsh-associated entity" in a form of extortion, and criticised voclosporin in a (now deleted) post on LinkedIn that claimed the drug had not shown any clinical benefit to patients.

Tidmarsh denied all those allegations. Meanwhile, Aurinia has said it lost $350 million in market value as a result of the statements.

The debacle is just the latest chaotic episode at the FDA and other agencies under the leadership of HHS Secretary Robert F. Kennedy Jr, coming after the resignations of CDC director Susan Monarez and former CBER head Peter Marks, as well as other senior agency figures. All have said their decisions to leave stem from concerns that HHS agencies are being undermined by an attempt to replace scientific principles with Kennedy's personal agenda, which includes a long history of vaccine scepticism.