Friday, February 16, 2007

Sanofi Aventis - Ketek: is the FDA "badly broken"?

Roy Poses has a great analysis.

On Monday, the US Food and Drug Administration announced that Ketek would no longer be approved for sinusitis and bronchitis, relatively mild infections for which many other antibiotics are available. It also announced more "black-box" warnings for Ketek. (See this report by Bloomberg News, for example.) In preparation for a sub-committee hearing in the US House of Representatives about FDA oversight in this and other cases, Representative Edward Markey (D- Massachusetts) called these warnings "overdue," and suggested there was "no coincidence" about the timing of the FDA announcement prior to the committee hearing. The Associated Press (here via the Washington Times) quoted Markey, "it appears that a healthy dose of congressional oversight has reminded them to do their job and ensure the safety of drugs on the market." The AP also quoted Senator Grassley, "the FDA's action today shows what transparency can do. When a spotlight was turned on the questionable way in which Ketek got approved by the FDA for certain sinus and lung infections, the FDA was held accountable."

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