Turmoil at FDA as CDER Chief Resigns Amid Controversy and Lawsuit

In a shocking turn of events, Dr. George Tidmarsh, head of the FDA's Center for Drug Evaluation and Research (CDER), has resigned following a controversial LinkedIn post and subsequent lawsuit. This development marks the latest in a series of high-profile departures from the agency, highlighting ongoing turbulence within the FDA under the current administration.

Tidmarsh's Resignation and the Aurinia Lawsuit

Dr. Tidmarsh's resignation came after he was placed on administrative leave due to "serious concerns about his personal conduct," according to an HHS spokesperson. The controversy stemmed from a now-deleted LinkedIn post criticizing Aurinia Pharmaceuticals' lupus nephritis medication, Lupkynis (voclosporin).

In the post, Tidmarsh claimed that Lupkynis carried "significant toxicity" and "has not been shown to provide a direct clinical benefit for patients." This statement prompted Aurinia to file a lawsuit against Tidmarsh in Maryland federal court, accusing him of making "false and defamatory statements" driven by a "longstanding personal vendetta against Kevin Tang," Aurinia's board chair and major shareholder.

The lawsuit alleges that Tidmarsh's actions stem from a 2019 incident when Tang, then board chair of La Jolla Pharmaceutical Company, requested Tidmarsh's resignation as CEO. Aurinia's legal team claims that Tidmarsh has since "repeatedly threatened that he would exact revenge against Mr. Tang over these ousters."

FDA Leadership in Disarray

Tidmarsh's departure is not an isolated incident but part of a broader pattern of instability within the FDA and HHS. Recent months have seen several high-ranking officials leave their posts under contentious circumstances:

• CDC Director Susan Monarez was pushed out less than a month after her confirmation, claiming she was "targeted" for refusing to "rubber-stamp unscientific, reckless directives."
• Dr. Vinay Prasad, the FDA's chief science and medical officer, briefly resigned from his role as head of the Center for Biologics Evaluation and Research (CBER) before being reinstated a week later.
• Dr. Peter Marks, Prasad's predecessor at CBER, abruptly resigned in March, later suggesting he was forced out for refusing to grant HHS Secretary Robert F. Kennedy Jr. unrestricted access to the federal vaccine injury reporting system.

These departures, coupled with deep staff cuts under the Trump administration's efficiency drive, have left the agency in a state of upheaval.

Implications for Drug Regulation and Industry Relations

The controversy surrounding Tidmarsh's LinkedIn post and subsequent resignation raises questions about the FDA's relationship with the pharmaceutical industry and the agency's approach to drug regulation. Tidmarsh had previously spoken about the need to "remove harmful, useless drugs from the market" and criticized instances of scientific misconduct in academic research.

In his defense, Tidmarsh told The New York Times that he believes the FDA review of his actions was itself retaliatory, linked to concerns he raised about the agency's new national priority review voucher program. He described a "toxic environment" at the agency under Dr. Prasad's leadership.

As the pharmaceutical industry and regulatory bodies grapple with these developments, the impact on drug approvals, clinical trials, and industry-agency relations remains to be seen. The ongoing turmoil at the FDA underscores the challenges facing the agency as it attempts to balance innovation, safety, and public health in an increasingly complex pharmaceutical landscape.