FDA refers Avandia panelist conflict of interest case to HHS Inspector General

In the wake of reports earlier this week that some members of the Avandia advisory committee may have had conflicts of interest, the FDA said on Friday that it had referred the case of one panel member, David Capuzzi, to the Health and Human Services Office of Inspector General.

The FDA sent CardioBrief the following statement:

FDA has completed its fact-gathering process and has referred the Dr. Capuzzi matter to the HHS Office of Inspector General. FDA is prohibited by law to release Dr. Capuzzi’s or any member’s confidential financial disclosure form or to comment on what is or is not disclosed in a form. Dr. Capuzzi has the right to voluntarily provide his form for public review. The agency cannot comment on an ongoing investigation.


As initially reported in the Wall Street Journal and Pharmalot, panel member David Capuzzi, an endocrinologist at Thomas Jefferson University, received over $14,000 in recent years for speaking about Lovaza, GSK’s omega-3 pill. Capuzzi was one of only three panel members who voted in favor of keeping Avandia (rosiglitazone) on the market with no additional restrictions.

Capuzzi told Pharmalot earlier this week that “in the past, I’ve spoken for another drug, Lovaza, but the FDA doesn’t consider a different product for the same company to be a conflict of interest.” However, FDA officials have pointed out that FDA’s guidance on conflict of interest disclosure for advisory panel members requires that disclosure statements include any conflict “related to the sponsor,” not just the product under consideration [emphasis added]. The FDA pointed out that “failure to disclose this type of information to FDA prior to selection or participation on the EMDAC reviewing Avandia is illegal.”

A second round of reports earlier this week focused on panel member Abraham Thomas, who gave two Takeda-sponsored talks about Actos between September 2007 and September 2008. However, the FDA told CardioBrief that “members are required to report all current financial interests and those held within the previous 12 months.” Abraham said that he had disclosed his relationship with Takeda to the FDA. As the talks took place more than a year ago Thomas does not appear to be the subject of any current investigation.

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  1. […] to remove Avandia from the market or change its warning label in light of the medical issues.  Only 3 members voted to do nothing and 1 member abstained.  Now, we hear that one of the 3 members who defended Avandia and voted […]

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