As Avandia dust settles, observers draw conclusions

Call it Monday-morning quarterbacking. The FDA's decision on GlaxoSmithKline's Avandia is still getting plenty of rehash in the press. And why not? It's the biggest drug-safety decision we've seen in several years. Here's a sampling of the commentary.

  • The FDA didn't withdraw Avandia, but shackled it with tight restrictions. Forbes' Matthew Herper argues that this choice signals FDA will rely on its new powers to compel risk evaluation and mitigation system (REMS). The mass-market drug recall--think Vioxx and Zelnorm--could be a thing of the past. Report

  • The FDA's willingness to admit shades of gray in its decision on Avandia is a brand-new approach for the agency, the New York Times points out. Given that data analysis is more complex these days, that tolerance for gray will have to continue, experts say. Article

  • Last week, the Wall Street Journal noted that the FDA decision illustrated just how influential CDER chief Janet Woodcock continues to be at the agency. John Mack at the Pharma Marketing Blog now posits that Woodcock is well positioned to take over as FDA Commissioner should the Republicans manage to win the White House in 2012. News

  • Cardiologist Harlan Krumholz dissects the FDA's Avandia decision for Pharmalot. Among Krumholz's questions for FDA: Why did it take so long to restrict the diabetes drug? Why did the agency focus risk-management on new users of the drug, rather than all users? Does the Avandia episode further erode the surrogate-markers approach to drug approval? And finally, will we learn anything from Avandia? Item