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PHARMA/POLICY/POLITICS: FDA Official Quits Over Delay on Plan B, with UPDATE

The FDA official in charge of women’s health quits over the delay on Plan B‘s approval. Well it’s good to see that some of the staffers left at FDA have some spine, because it’s clear that, whatever the lies being told by the Administration, this is all about cow-towing to the loonies on the Christian right rather than the science of the situation.

There are a couple of telling shots in the story. Crawford swore up and down that this was his decision and that it was a science-based one.  Not so. 

Susan F. Wood, assistant FDA commissioner for women’s health and director of the Office of Women’s Health, said she was leaving her position after five years because Commissioner Lester M. Crawford’s announcement Friday amounted to unwarranted interference in agency decision-making. "I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," she wrote in an e-mail to her staff and FDA colleagues"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," she wrote in an e-mail to her staff and FDA colleagues.

Of course there were strenuous denials from all concerned, but what was she told?

Wood also said other FDA officials who are typically involved in important matters were kept in the dark about the contraceptive, called Plan B, until Crawford announced his decision, which she believed was made at higher levels in the administration. Wood said that when she asked a colleague in the commissioner’s office when the decision would be made, the answer was, "We’re still awaiting a decision from above; it hasn’t come down yet."

So you could argue that this was not Crawford doing what he thought the loonies wanted him to do, but instead he was actually taking instructions from Leavitt or Rove or whomever.  On this issue  they can send a sop to their "social conservative" friends. After all it’s only a small pharma company they’re pissing off here, not a big one, Just as well Lipitor doesn’t impact birth control, eh?

Meanwhile, there’s just a delicious piece of doublespeak from Leavitt that really outdoes some of the stuff we’ve had to put with from Rumsfeld over the years:

Many supporters of the Plan B application — including Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) — accused Crawford of making a political decision that ignored science and public health. The two senators were especially angry at Crawford’s ruling because they had lifted a hold on his pending nomination based on promises, relayed by HHS Secretary Mike Leavitt, that the Plan B issue would be resolved by Sept. 1.

Clinton and Murray have accused the administration of breaking its promise, but Leavitt has disagreed. "The commitment was they would act," he told Reuters on Monday. "Sometimes action isn’t always yes and no. Sometimes it requires additional thought.

So now when you’re asked by your wife, boss, teacher, whomever why you haven’t done something you were supposed to have done (you know, "taken action") you can tell them that you were thinking about it and that is exactly the same thing! Not only that — it’s now official policy in what passes for the circus we call a government.

UPDATE: Bob Steeves points me to this quote from the spokesman for Mike Enzi (a Senator with an "R" after his name), showing that he didn’t get the Talking Points on this one and looks a little pissed:

Sen. Michael B. Enzi (R-Wyo.), chairman of the Health, Education, Labor and Pensions Committee, is considering whether to hold hearings on the FDA’s handling of Plan B, said spokesman Craig Orfield. Enzi had expected "a firm decision" from the FDA, not further delays, Orfield said.

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Joe C.matt Recent comment authors
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matt
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matt

The common theme across both the Plan B and Vioxx scenarios is a disregard for science.
FDA is taking its job to the administration seriously; to the American people… another question.

Joe C.
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Joe C.

Sounds more like another Clinton holdover, trying to ride the media gravy train. “…she asked a COLLEAGUE IN THE COMMISSIONER’S OFFICE (the admin.) when the decision would be made, the answer was, “We’re still awaiting a decision from above (the Commissioner); it hasn’t come down yet.” Why would unfounded political accusations by HRC and Patty Murray (of all people) be taken seriously by anyone, except an another unknown Republican Senator lookin’ for some “maverick” pub by the Media (a la Hagel, DeWine, Voinovich)? See, I’ve learned this parsing and conspiracy theory game as well. Vioxx too fast, not enough study… Read more »

matt
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matt

Verb: fixin’ – to have contemplated action but not yet taken any.
In a sentence: Lester Crawford was fixin’ to make a decision on Part B but hadn’t actually made one yet.
or
Lester Crawford was fixin’ to quit banging his secretary when he was questioned about it by the Senators.