While the agency followed its general procedures for considering Barr Laboratories Inc.'s application to approve its "Plan B" pill for over-the-counter sales, aspects of its review process were "unusual," the Government Accountability Office, which serves as Congress' investigative arm, said in its report.
FDA's scientific advisors in 2003 overwhelmingly urged approval of the OTC application. The agency typically follows the recommendations of its advisory panel. But FDA in May 2004 rejected the application, citing worries about use of the pill by young teens without a doctor's supervision.
Barr reapplied to sell Plan B without a prescription to women 16 and older, while requiring prescriptions for those under 16. The FDA in August indefinitely postponed a decision on the application, citing uncertainty about its ability to enforce age limits.
The GAO probe found that high-level FDA officials were more involved than is usually the case in decisions to approve drugs for over-the-counter use. Also, investigators found conflicting accounts as to whether the decision to reject the application for OTC use was made before the agency's reviews were finished, the report said.
How many contradictions can you find?
I love how the FDA says that they couldn't guarantee that under-age kids would use Plan B--what about cigarettes? Plan B prevents life from occuring while cigarettes prevent life from continuing. That's the most absurd argument I've heard in a while--OK, it really isn't--what absurd argument could hold a candle to "we've got to stay the course in Iraq because if we pull out, the terrorists win."
Regardless, it's just as stupid and simplistic an argument.
What the Plan B rejection really boils down to are these faux-morals these faux-Christians in DC are going on about. They get all up in the faces of so-called "activist judges" when they say things like "the use of the word 'God' in the Pledge of Allegience is unconstitutional" yet it's totally cool for a bunch of Washington Republicans to try and change Florida law so that one woman in a vegetative state isn't put out of her misery.
So, here we have the FDA rejecting a pill that some might call "an instant abortion." Well, I happen to not be cool with abortions myself--however, I'm all about the freedom to do what I want with my own body and if I had a womb I'd expect to have ultimate control over what I let grow in it. However, those damn hypocritical Republicans in DC are too busy killing Iraqis and USGIs to realize that killing unborn babies isn't anywhere near as bad as killing Iraqis and USGIs.
Isn't that funny? Those damn Republicans are all about the sanctity of 1) marriage, 2) life and 3) the White House, yet we get to deal with the following:
1) When gays want to get married, they're second-class citizens.
2) When 2000 American lives are lost in Iraq and tens of thousands of Iraqi lives are lost, they say (effectively) plenty more will have to die or the terrorists win.
3) When Bush says there are WMD in Iraq, a threat to America in Iraq, that he'd get Osama dead or alive, and is wrong on all counts, we are told mistakes happen. On The Colbert Report last Monday night former Nebraska Senator Bob Kerrey reminded us that Clinton was impeached over a lie about sex. How many more things does Bush have to get wrong before he gets impeached?
Ah, you Republicans. It's nice to hear that, according to NYT [http://nytimes.com/2005/11/15/politics/15cong.html?ei=5094&en=1b0f7720627f5fd3&hp=&ex=1132117200&partner=homepage&pagewanted=print|you want to push Bush to come up with an exit strategy from Iraq] but this is not enough to regain the trust of this American citizen.
I'd feel this way regardless of what person was in the White House. If Gore had pulled this crap I'd be ranting about him, instead. This isn't about right or left, this is about laws and justice. When are you Republicans (and you lazy-ass Democrats) going to do something about how you're all going to look in the eyes of history? What am I saying? History is written by the winners--even if they are a bunch of losers.
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