FDA Panel Mixed on Avandia Approval

FDA Commissioner Margaret A. Hamburg will make the final decision about future use of diabetes drug Avandia, made by GlaxoSmithKline PLC.

The majority of medical experts on today's FDA panel (20 of the 33 members) voted to keep Avandia on the market, with 12 voting for removal and 1 abstention. Twelve people voted to remove the product from the market, and one person abstained. Several panelists recommended that stronger label or usage restrictions be applied.

Both plaintiff and defense attorneys have been following the hearings. The broader policy question relates to public safety protection when adverse new findings become available regarding a medication that is already in the market.

In anticipation of the vote, Glaxo has been working to settle many of the lawsuits outstanding. See "GSK settles bulk of Avandia suits for $460M" in FiercePharma.com. According to the article, plaintiff attorneys are pleased with the settlement efforts. An earlier blog post commented on Internet-based class action marketing campaigns being used in the effort to attract Avandia users.