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PHARMA/POLICY: The outsider the FDA needs is the consummate insider, with comment from Blunter

Two days before the latest hearings on Vioxx and Celebrex, with a stand-up Republican Senator all but accusing the FDA management of fraud, Bush names the new head of the FDA. And who gets the gig? None other than the guy who’s been temporarily running it onto the rocks. Crawford, the acting head of the F.D.A. is the new leader. THCB contributor and ex-FDAer Blunter last month suggested that a real outsider was needed to rescue the agency. While he wasn’t expecting Syd Wolfe to get the job (and the NY Times has a big profile on Wolfe today too), you can assume that the appointment of Crawford was not what Blunter was looking for. He writes:

Aaarrggh! The President?s nominee to head the Food and Drug Administration is none other than the current acting head: Lester Crawford. This is a real life Phoenix rising out of the ashes of death, and ashes that he created. With controversy swirling around the FDA and its treatment of and failure to protect whistleblowers, and warnings on Vioxx and other COX-2 inhibitors, and then the Adderall situation, and the surreptitious change in the antidepressant labeling, the odds of such a miserable record were against him retaining his present job, let alone getting a promotion.

Any FDA Commissioner nominee must face a Senate confirmation process. As some of my exile friends from Cuba would say: "We ought to hire a balcony for this one." Look on the FDA Web site and see Crawford’s resume — devoid/scrubbed of any association with regulated industry interests. Those who know Crawford say he was once associated with American Cyanamid and several industry groups and associations. Last time his resume was floated for possible confirmation as FDA Commissioner, the ranking minority member on the committee that handles this nomination, Senator Kennedy (D-MA) telegraphed a "dug in" opposition position, and the nomination did not see the light of day.

What a political donnybrook the President has created for himself. Here will be the person who is presiding over one continuing debacle over drug warnings and safety incidents being put into the spotlight in a public confirmation process. Expect real fireworks here that are likely to doom the nomination and wash over onto the Presidency.

Furthermore, the need for the head of the FDA to be paying attention to business is critical right now, and the need to get a Commissioner in place as quickly as possible is also critical. But in the current controversial context surrounding many FDA decisions, who would think that the situation will get any better with the current FDA head off promoting his nomination on Capitol Hill and elsewhere.

No good can filter through to the FDA or the Bush Administration as a result of this faux pas.

Two things to note here. Without revealing his identity I can tell you that Blunter has strong Republican leanings, and thus you should take his views very seriously. Second he thinks that Crawford won’t make it through the nominating process. I’m not sure I agree. It may surprise you all to know that I am not a Republican, but even with some Republican support for some things that the FDA and the Administration opposes (e.g. reimportation) I’m not sure that the Senate has the guts to turn down any Bush nominee–after all they just confirmed torture-memo man Gonzales for AG.

But this will be an opportunity to drag more FDA laundry out in public — and after all the recent posturing by Leavitt, the appointment is made well before the IOM "reform" (whitewashing?) report that is supposed to fix the FDA’s problems. How this makes the FDA better is beyond me.

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