CDER in Turmoil: A Timeline, the Aurinia Lawsuit, and What’s Next for FDA’s Drug Center
The Timeline
Oct 31: HHS placed George Tidmarsh, Director of FDA’s Center for Drug Evaluation and Research (CDER), on administrative leave after its Office of General Counsel and Office of Inspector General were notified of “serious concerns about his personal conduct.” Fierce Pharma
Nov 2: Tidmarsh resigned, according to HHS and multiple outlets. Reuters+1
Nov 3: In a senior CDER/Office of New Drugs meeting, OND Director Mary Thanh Hai relayed that Tidmarsh said he was not resigning and intended to fight—reporting that echoed in trade coverage. The status remains fluid. BioSpace
Why he’s under fire: Defamation & bribery claims
On Nov 2, Aurinia Pharmaceuticals sued Tidmarsh, alleging he ran a personal vendetta against board chair Kevin Tang and defamed the company by posting on LinkedIn that Lupkynis (voclosporin) has “significant toxicity” and provides no “direct clinical benefit,” a post he later deleted as “personal opinion.” The complaint also alleges bribery/extortion tied to a services agreement connected to Tang-linked American Laboratories Holdings (ALI). (Read the complaint.) courtlistener.com+3The Washington Post+3The Wall Street Journal+3
Tidmarsh’s counter: It’s about CNPV
Tidmarsh told reporters he was sidelined because he questioned the legality of FDA’s new Commissioner’s National Priority Voucher (CNPV) pilot, which compresses some application reviews to 1–2 months culminating in a “tumor board–style” meeting. FDA announced the program and its first vouchers in October. U.S. Food and Drug Administration+1
Who’s running CDER right now?
Internally, Deputy Director Mike Davis is expected to cover duties while the situation plays out, per prior agency communications and trade reporting on his role. (No formal acting director has been publicly named by FDA as of this morning.) venable.com+1
Why this matters (beyond the headlines)
Regulatory predictability: CDER’s leadership vacuum lands just as PDUFA VIII (FY2028–2032) reauthorization work ramps up—public kickoff was July 14, 2025, with monthly stakeholder consultations required by law. The spring layoffs of FDA negotiation staff already raised alarms about bandwidth. Reuters+3U.S. Food and Drug Administration+3U.S. Food and Drug Administration+3
Market impact: Executive commentary from multiple outlets ties Tidmarsh’s post to a sharp Aurinia share decline—a reminder that senior FDA officials’ public statements can move markets and trigger litigation. news.bgov.com
Program oversight: If concerns about CNPV’s legal footing persist, sponsors using vouchers should expect scrutiny of process, documentation, and decision records. FDA’s public materials describe the new model and its one-day review conference; teams should align internal narratives accordingly. U.S. Food and Drug Administration+1
What sponsors should do now
Confirm points of contact. Before key meetings, verify reviewer and leadership lines in OND divisions; expect delays or reschedules as roles shuffle.
De-risk communications. Treat social media and public statements by all executives as material; mirror FDA’s “cautious, evidence-based” tone in your own messaging.
Plan for review variability. For near-term submissions, over-document benefit–risk and CMC robustness; anticipate extra clarification rounds.
Follow PDUFA VIII milestones. Track consultation calendars and any shifts to the draft Goals Letter timeline as FDA stabilizes staffing. Federal Register
Bottom line
The CDER director saga is still unfolding: leave → resignation → pushback—with litigation in the background and policy debates (CNPV) up front. Until FDA formalizes interim leadership and clarifies next steps, sponsors should build buffer into interactions, keep records tight, and watch for official updates.
Sources: Reuters; Washington Post; Wall Street Journal; FiercePharma; BioSpace; FDA.gov (CNPV program and PDUFA VIII meeting notice); Federal Register; Bloomberg Law/BGov; court filings. news.bgov.com+11Reuters+11The Washington Post+11
