News from the FDA

Avandia Update: Study suggests Actos and Avandia have comparable cardiovascular effects as researchers suggest caution in interpretation of results.

Our Take: The results of a study comparing Actos & Avandia are being interpreted as demonstrating that risks associated with Actos are similar to those for patients having taken Avandia. The issue emerges as the FDA considers action it will take regarding Avandia. The manufacturer of Avandia, Glaxo, did itself no favors with in terms of its relationship with the FDA. In complying with an agency request to send a letter to physician investigators in the TIDE trial, the drug maker sent a letter that was characterized by Dr. David Graham at the FDA as being "biased, misleading and not truthful."  The New York Times wrote more on this. Although the study was published in a major journal, some experts are warning against extrapolating the findings to the two drugs, noting that an abundance of data exists in their opinion, to implicate Avandia as being a riskier drug. We'll continue to monitor FDA action on this drug.

FDA may begin prosecuting company executives for firms with numerous recalls due to manufacturing violations.

Our Take:  This appears to be part of the evolving focus of the agency, which includes increasing emphasis, on surveillance and enforcement. Eric Blumberg the agency's chief counsel for litigation announced at an industry meeting in April that the agency would pursue executives at firms that appeared to be disregarding agency rule. Likewise, this spring Commissioner Hamburg communicated with Senator Grassley that the agency will consider "the appropriate use of misdemeanor prosecutions."  The issue appears to be front of mind as more and more controversy surrounding Johnson and Johnson's recall concerns have increased the visibility these indiscretions in the manufacturing process can have. More is written on this subject here.

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