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PHARMA/POLICY: Deja vu all over again at FDA. But so blatant and so soon! by Blunter

Blunter is back with more concerns about whether the FDA Is whitewashing away its problems. Chuck Grassley this morning probably agrees with him, considering that he yesterday accused the FDA of interfering with Canada Health’s decision over withdrawing Adderall for political purposes. Here’s Blunter with a review of some of the details of the Leavitt confirmation that didn’t make it into the mainstream press:

In an earlier post on your site I characterized the Institute of Medicine study of drug safety issues as just a familiar CYA tactic, full of sound and fury but signifying nothing. You will recall the IOM study was quickly arranged by the FDA Topside in response to its whistleblowers, and widespread disgust just about everywhere. To quote a passage from that post:

FDA seeks an analysis and report by the National Academy of Science or other prestigious group as a "CYA" tactic. There are lots of similar reports lying around comatose from past misadventures. However, the tactic permits FDA and other Administration folks to say it is inappropriate to discuss specifics of the latest debacle(s) before receipt of the blue ribbon report. Hence, we have FDA on autopilot until the dust and fervor clears and a new executive crew gets in that can say that "it wasn’t on our watch."

Less than a month has passed. Lo and behold,the newly-minted HHS Sec Leavitt must have read the blog. In a written response to a Senate Finance Committee question about moving on FDA safety reform now–and I am not making this up–Leavitt "stressed his desire to wait until the Institute of Medicine completes a review of drug safety regulation in the U.S. before proposing any major overhaul". Trade press reports say that Leavitt "repeatedly cited his desire to wait for the outcome of IoM review" in response to as series of questions from [Senator] Grassley [Chmn of the Senate Finance Cmte] about alternative models for drug regulation. (Ed’s note–I have the confirming transcript but it’s not easily available on the web).

Is it any wonder that the White House is reported to be continuing its search for a new FDA Commissioner? Let’s hope that look is outside the confines of physicians and scientists and considers seasoned managers, perhaps with an MBA or a record of success in other large, technical enterprises. The new head needs to delve into management as well as legal reforms to rectify the incompetence of the present "team" and not merely deflect the heat from the current topsiders and their shortcomings.

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