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

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.

Wolfe’s tenure expired May 31, and Dal Pan’s public acknowledgement is part of the traditional send-off for panelists whose term...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA Performance Tracker

More from Regulatory Trackers