Avandia: How do you hold a moon beam in your hand?
This article was originally published in RPM Report
FDA faces a tough decision on Avandia. Should it stay or should it go? There is bigger underlying issue: should the standard be different for pulling a drug than it is for approving the drug in the first place? It may be counterintuitive, but a different standard makes sense.
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The new group of Drug Safety & Risk Management Advisory Committee members comprises a lot of familiar faces. FDA has made use of its extensive outside academic connections, research grants and post-graduate training programs to bring in eight members for the Classes of 2013 and 2014. Most of them have been getting extensive on-the-job training with the advisory committee already.
FDA learned two important lessons from the Avandia debacle. First, the agency needs to be a better communicator—which means telling the public more about what it knows (and doesn’t know) about the safety of marketed products. But Avandia is also leading the agency to rethink what should be required to demonstrate safety, especially for chronic care therapies. Both could mean big changes for industry.
Going into the Avandia re-review, FDA looked stuck between a rock and a hard place. Coming out of the FDA advisory committee meeting, the agency has a full set of options to choose from that would likely be viewed as a credible outcome by the public. But possible surprises remain.