The agency wants its Endocrinologic and Metabolic Drugs Advisory Committee to decide whether clinical trials to evaluate cardiovascular risks should be undertaken before the meds are approved or after marketing begins and the drugs are used by the population at large.

The move comes after severe warnings were placed last year on Glaxo’s Avandia and Takeda’s Actos diabetes pills, both of which were available for eight years before new studies raised questions about cardiovascular risks. The meeting takes place next Tuesday and Wednesday.

“A requirement for demonstrating cardiovascular benefit will likely have major implications on the availability of new treatments for type 2 diabetes, because conclusive evidence of a reduced risk of macrovascular complications in type 2 diabetes has not yet been established for any of the currently available antidiabetic medications, including insulin,” according to the FDA briefing documents.

“In addition, a requirement for long-term cardiovascular benefit would prompt questions as to why currently marketed therapies (all lacking evidence of such benefit) should remain available. Establishing a hurdle of long-term, costly trials to exclude cardiovascular harm may also affect drug development for type 2 diabetes, particularly if this mandate applies to every product, even those that have no suggestion of cardiotoxicity.”

By the way, conflict of interest waivers were granted three panel members - Tom Bersot, a University of California at San Francisco professor, who holds stock in one unnamed drugmaker that was valued at between $25,000 and $50,000. Another is Bob Califf of Duke University, which has research contracts with unnamed drugmakers, and he also has consulting contracts with pharma. The last is Steve Nissen of the Cleveland Clinic Foundation, which has numerous research contracts with several unnamed drugmakers. His Avandia meta-analysis last year triggered the current debate. Both Nissen and Califf are non-voting panel members. Here are the waiver forms.