Behind the Headlines Episode 28: Navigating FDA Shakeups and Obesity Drug Wars
In Episode 28, Miroslav Gasparek from Sensible Biotechnologies, Lizzy Lawrence, FDA reporter at STAT, and Joe Lewis, managing director at Deloitte Consulting, discuss recent developments affecting the pharmaceutical industry. The bi-weekly Behind the Headlines series explores the trends and underlying factors shaping pharma news, featuring insights from consultants, venture capitalists, scientists, patient advocates, journalists, and editors.
Focus on FDA Vaccine Center Turmoil
The panel highlights a growing erosion of expertise within the FDA’s vaccine center. While Vinay Prasad has resumed leadership, the organizational structure remains fractious, with former leader George Tidmarsh having “resigned” alongside multiple staff departures. One panelist described the situation as “uncertainty on top of uncertainty.” This instability represents a critical moment for the FDA and its many stakeholders, including patients.
Impact on Huntington Disease Drug Approval
On the day of recording, a significant development underscored the situation: UniQure’s anticipated approval of its Huntington disease candidate AMT-130 now appears doubtful. UniQure characterized the FDA feedback as a “key shift from prior communications” and indicated a bleak outlook for the timing of their approval request.
“Uncertainty on top of uncertainty.”
UniQure described the feedback as a “key shift from prior communications,” and said the timing of its plan to ask for approval of AMT-130 now looks bleak.
Author’s summary: The episode reveals deep challenges within the FDA’s vaccine center, marked by leadership changes and organizational instability, which are impacting critical drug approvals and industry confidence.