FDA CDER Director George Tidmarsh Placed on Leave Amid Probe Over Drug‑Approval Program Concerns

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) confirmed that George Tidmarsh, the agency’s director, has been placed on administrative leave. The move follows internal concerns he raised about a newly‑launched “fast‑track” drug‑approval initiative and a subsequent investigation into alleged retaliation against a company linked to a former business associate. The FDA has not yet disclosed the specifics of the leave or the status of the investigation.

Key Facts

• Who: George Tidmarsh – Director, FDA CDER; former biotech executive and adjunct professor at Stanford School of Medicine.
• When: Placed on leave effective immediately (announcement reported by the New York Times).
• Why:
• Raised objections to a rapid‑approval program for new drugs.
• Allegations surfaced that he may have used regulatory authority to retaliate against a firm connected to a former associate.
• Investigation: An internal FDA review is underway; no formal findings have been released.
• Background:
• Appointed CDER head in July 2025, succeeding Vinay Prasad, who departed abruptly.
• CDER is the FDA’s largest branch, overseeing all OTC and prescription drug approvals.
• Tidmarsh’s tenure began as Sarepta Therapeutics faced heightened scrutiny of its gene‑therapy portfolio, including the flagship product Elevidys.

Context & Implications

• Fast‑Track Approval Program: Designed to accelerate market entry for promising therapies, the program has drawn criticism from some regulators who fear compromised safety reviews.
• Regulatory Oversight: The leave underscores the FDA’s heightened sensitivity to potential conflicts of interest and the importance of maintaining public trust in the drug‑approval process.
• Industry Reaction: Stakeholders are monitoring the situation closely, as any shift in CDER leadership could affect pending drug reviews and the broader regulatory timeline for innovative therapies.

What’s Next

• The FDA is expected to issue a formal statement within the next 48 hours outlining the scope of the investigation and any interim leadership arrangements at CDER.
• Congressional committees may request briefings on the matter, given the implications for drug‑policy and public‑health oversight.

Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual outcomes may differ materially from those expressed herein.-Fineline Info & Tech