Reuters: Plan B decision made before data review: FDA staff

[Eugene]

Plan B decision made before data review: FDA staff

By Susan Heavey | August 3, 2006

WASHINGTON (Reuters) - The decision whether the U.S. Food and Drug Administration
should approve wider access to a morning-after contraceptive drug was made well
before agency scientists finished their final review, two FDA officials said
in court documents released on Thursday.

Supporters of over-the-counter sales for Barr Pharmaceuticals Inc.'s Plan B pills have
accused top FDA officials of hindering the company's bid for nonprescription sales
for years, to please conservative supporters of President George W. Bush's
administration.

The documents come just days after the FDA said it would reopen discussions
over the drug, which can prevent pregnancy if taken within 72 hours of sexual
intercourse. The delay had stirred debate over politics and science and held up the
confirmation of two agency chiefs.

In a sworn statement in June, Dr. John Jenkins, director of the FDA's Office
of New Drugs, said he learned in early 2004 that then-FDA Commissioner Mark
McClellan had decided against approval before the staff could complete their
analysis.

-snip-

Full article: http://abcnews.go.com/US/wireStory?id=2272140

[struggle4progress]

1. Plan C (11/30/2005)

by Brian Morton

... Six months ago, the FDA rejected over-the-counter sales of Plan B, also known as the “morning-after pill.” As a Government Accounting Office report showed, top Bush administration officials jumped into the decision-making process, something the GAO report noted was “very very rare,” and then they ignored both the advice of an independent advisory committee and the FDA’s scientific review staff. The GAO report concluded that a top FDA official created a “novel” rationale for rejecting Plan B’s over-the-counter status, even making the decision before the review process was concluded ....

http://www.citypaper.com/columns/story.asp?id=11193

[niyad]

2. and does this come as a surprise from this woman-hating bunch of

fundie zealots?

[TroubleMan]

3. The repugs would rather you use plan D:

[Erika]

4. W's theocracy in play

Women are only....women.

[radfringe]

5. HUH?

bushisms contagious???

McClellan, who led the FDA when Barr submitted its application in 2003, said he gave updates to the White House as a matter of course but denied they told him what to do.

"If I was being given any direction on how I should act on this application, I would have remembered that because that never happened," McClellan said in a June sworn statement.

[oostevo]

6. Where's the Bushism?

I'm certainly not pleased with the way the Plan B mess is turning out, but I honestly can't see a Bushism in that sentence. To me, it seems like that parses correctly and isn't redundant.

But maybe I'm just being dense.

Mind mentioning where the it is? I love laughing at these guys.

[radfringe]

7. read again

..."I would have remembered that because that never happened"

[oostevo]

8. Oops

Yup, you were right.

In other news, public speaking is apparently still hard, particularly when sworn in.

[radfringe]

9. Yup - and it seems it's contagious

I know it's widely known as a bushism... however - I often refer to this as a TTTS (Texas Tangle Tongue Syndrome)

and the quote is buried in this article: http://abcnews.go.com/US/wireStory?id=2272140