12:00 AM
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Sep 09, 2013
 |  BioCentury  |  Regulation

Better decisions post-Avandia

How FDA aims to resolve future drug safety questions faster than Avandia

Three doctors who sit on FDA's Endocrinologic and Metabolic Drugs Advisory Committee have asked the agency to ease cardiovascular requirements for diabetes drugs now that it is known that Avandia rosiglitazone from GlaxoSmithKline plc did not pose the CV risk that meta-analysis had suggested it might.

The agency said it is "premature" to discuss its stance on the requirements for CV testing of diabetes drugs. But there are at least two initiatives under way that could help FDA more swiftly address safety questions that arise postmarket.

First, FDA is building its Sentinel system to query electronic patient records to identify and monitor postmarket safety concerns. The agency has already conducted at least two pilot postmarket safety assessments.

Second is FDA's benefit-risk framework initiative, which includes an effort to develop a consistent approach to assessing the strength and credibility of different kinds of postmarketing evidence and deciding how to weigh that evidence in making regulatory decisions.

When a meta-analysis raised the alarm about Avandia in 2007, FDA lacked such tools to assess drug safety and weigh postmarket evidence. As a result, the agency was unable to fight off public and political pressure that eventually killed Avandia and imposed burdensome requirements for CV testing on all new diabetes candidates.

After six years, one 4,447-patient CV outcomes study and a third-party re-analysis of that study, the findings of the 2007 meta-analysis were invalidated. Both analyses of the RECORD study showed no increased CV risk for Avandia (see BioCentury, June 10).

But the damage had already been done. Avandia lost 99% of its sales, which fell to £6 million ($9 million) in 2012 from £1.4 billion ($2.2 billion) in 2006.

Additionally, FDA finalized guidance requiring companies developing any diabetes compound to rule out at least an 80% increase in CV risk...

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