FDA Refers Avandia Panel Conflict Question to HHS

Federal drug regulators have referred a potential conflict-of-interest problem on an <"http://www.yourlawyer.com/topics/overview/avandia">Avandia advisory panel to the inspector general’s office at the Department of Health and Human Services’ (HHS). Earlier this month, the sharply divided Food & Drug Administration (FDA) panel recommended that the controversial diabetes drug be allowed to stay on the market, but that sales be restricted and warnings on its label regarding heart risks be strengthened.

We previously reported that it was later discovered that one member of that panel, Endocrinologist David Capuzzi of Philadelphia, was a paid speaker for GlaxoSmithKline, the maker of Avandia. Glaxo’s website shows that he received $3,750 from the company as a speaker between April 2009 and March 2010. A spokesperson for the company also told The Wall Street Journal that he was paid $8,000 in speaking fees from the company before that period and an additional $3,000 in the second quarter of this year.

Dr. Capuzzi confirmed the relationship to the Journal, but said he never gave talks about Avandia. Since then, however, Glaxo has said Dr. Capuzzi once served on an advisory board on Avandia and received $750 for doing so, according to the Journal.

Dr. Capuzzi defended Avandia during the two-day meeting, and was among the three members who voted to allow the drug to stay on the market with no additional warnings or restrictions.

Dr. Capuzzi told the Journal he informed the FDA of his payments from Glaxo prior to the advisory panel meeting. However, others on the advisory panel were not made aware of them.

On Friday, the FDA issued a statement on the matter, saying “The FDA has completed its fact-gathering process and has referred the Dr. Capuzzi matter to the HHS Office of Inspector General.” According to the Journal, the agency did not release any other information.

Since November 2007, Avandia’s label has included a black box warning – the FDA’s strongest safety alert – detailing its association with myocardial ischemia. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack. Since the addition of the black box, evidence linking Avandia to an increased risk of heart attacks has continued to accumulate.

The FDA is not required to follow the recommendations of such panels, but does so in most cases. However, the lack of unity among panel members in the case of Avandia makes it hard to predict what the agency will do.

This entry was posted in Pharmaceuticals. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.