FDA Shakeup: Høeg's Departure and Amgen Drug Controversy

FDA Shakeup: Høeg's Departure and Amgen Drug Controversy

The FDA's dismissal of acting CDER director Tracy Høeg and the revelation of 20 patient deaths linked to Amgen's Tavneos in Japan create a dual crisis of regulatory leadership and drug safety. This analysis provides key takeaways, a timeline of events, and strategic implications for pharmaceutical BD and regulatory teams.

Key Takeaways

• The FDA terminated acting CDER director Tracy Høeg on May 16, 2025, after she refused to resign, continuing a pattern of leadership instability at the center.
• The FDA has proposed to withdraw Amgen's Tavneos, alleging "manipulated" trial data supported its approval, and has cited serious liver injury risks including deaths, according to Reuters.
• Pharma BD and regulatory teams should prepare for potential shifts in FDA review philosophy, increased scrutiny of post-market safety data, and possible market access restrictions for Tavneos.

What Happened: Høeg's Dismissal and the Tavneos Crisis

On May 16, 2025, the FDA fired Tracy Beth Høeg as acting director of the Center for Drug Evaluation and Research (CDER) after she declined to resign, according to internal sources. Høeg, who had served in the role since December 2024, was the fifth person to lead CDER in 16 months, continuing a pattern of leadership churn at the agency. Her tenure was controversial due to her history of vaccine skepticism, which had alarmed public health experts.

Concurrently, the FDA has proposed to withdraw Amgen's Tavneos (avacopan), a drug approved for ANCA-associated vasculitis, alleging that "manipulated" data supported its original approval. According to Reuters, the agency had previously asked Amgen to voluntarily withdraw the drug from the U.S. market amid concerns about trial data and liver toxicity issues, a request the company declined. The FDA's proposal to withdraw the drug cites serious liver injury risks, including deaths.

What Are the Regulatory Implications for Amgen's Tavneos?

The FDA's move to withdraw Tavneos represents a significant escalation in regulatory action. The agency alleges that manipulated trial data supported the drug's approval, and has cited liver toxicity issues that affected the drug's overall risk-benefit profile. The FDA in January 2025 asked Amgen to pull Tavneos from the market, citing liver toxicity issues, according to Reuters.

For BD teams evaluating rare disease assets, the Tavneos situation underscores the importance of thorough due diligence on clinical trial data integrity and post-market safety surveillance. The allegations of manipulated data could have broader implications for how the FDA reviews future rare disease drug applications, particularly those relying on single pivotal trials or surrogate endpoints.

How Should Pharma Teams Prepare for the Fallout?

The dual developments create significant uncertainty for pharmaceutical BD and regulatory teams. The FDA's leadership instability may slow drug review timelines and alter regulatory philosophy, particularly around post-market safety monitoring. Companies with pending applications should prepare for potential delays and increased scrutiny of clinical trial data integrity.

For BD teams, the controversy could affect Amgen's pipeline valuation and partnership negotiations, particularly in rare disease. Investors should watch for label changes, market withdrawals, or class-action lawsuits. Regulatory teams should engage early with FDA and EMA to address safety concerns proactively. The SEC filings for Amgen will be closely watched for any disclosure of material adverse events related to Tavneos.

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