Handicapping the July FDA panel on Avandia

The In Vivo Blog posted a very thoughtful preview of the FDA’s upcoming advisory panel on Avandia in July. It’s even possible that they’re not exaggerating when they call it “the most important single event for FDA’s drug review in 2010 and possibly beyond.”

Among other tidbits of information, the blog reveals that “Nissen recently met with FDA Commissioner Margaret Hamburg and [Principal Deputy Commissioner] Sharfstein to make the case that the TIDE trial was unethical and that Avandia needed to be withdrawn.”

Another FDA critic is Rep Rosa DeLauro, who in her role as the House Agriculture Appropriations Subcommittee holds the FDA’s purse strings. The post quotes a DeLauro spokesperson: “She believes that the TIDE trial is unethical and should be halted immediately, and has urged the FDA before to remove Avandia from the market until a truly independent, science-based advisory panel can evaluate the safety and effectiveness of the drug.”

DeLauro and others have proposed that the FDA’s Center for Drug Evaluation and Research (CDER) should be split into two separate centers, one for new drug applications and one for post-market surveillance.

The preview raised several other intriguing questions about the panel:

  • Who will be on the panel and how many members will there be?
  • Will the full pioglitazone safety data be presented?
  • Will Nissen present? (At the 2007 meeting Nissen did not present his meta-analysis which of course sparked the entire controversy.)

Ultimately, In Vivo suggests, the final decision on Avandia will reflect the degree to which Hamburg and Sharfstein are able “to brand the Obama Administration’s FDA as a public health agency.”

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  1. […] panel for July 13-14 in Gaithersburg, MD. The notification appears in the Federal Register. As previously speculated in the In Vivo blog, the FDA will also present a meta-analysis of trials of pioglitazone. It is also widely anticipated […]

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