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Lone Wolfe: Drug Industry Critic Ends Tenure As Advisory Committee Member With Rare Decisive Vote

 
• By Laura Helbling and Michael McCaughan

Sidney Wolfe’s stint as permanent member of the Drug Safety and Risk Management Advisory Committee ended May 31; his final meeting was the May 23 review of Xarelto for ACS. That gave him a second chance to vote against the product. A look back at Wolfe’s tenure shows he was a sure “no” vote when he sat on a panel—but that his service can hardly be construed as having damaged the industry.

After the lunch break during the May 23 Cardiovascular & Renal Drugs Advisory Committee review of Johnson & Johnson/Bayer AG’s Xarelto for a new indication (acute coronary syndrome), Office of Safety & Epidemiology Director Gerald Dal Pan thanked Public Citizen Health Research Group Director Sidney Wolfe for his four years of service as a member of the Drug Safety & Risk Management Advisory Committee.

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US FDA’s March Approval Candidates Take Aim At Established Markets

 
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Global Pharma Guidance Tracker – February 2025

 
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