November 15, 2005

Politics Trumps Science at FDA?

The GAO has issued a report stating that the recent FDA ruling on relaxing access restrictions to "Plan B" contraception was "unusual" in a number of ways.

Notable among the irregularities was Former Food and Drug Administration commissioner Mark "I'm Proud of Scott" McClellan's involvement in the decision. He came out as an opponent early on. In an environment of wide support within the FDA on the science, the proposal was inexplicably rejected.

Many proponents of easier access to Plan B charge that political considerations had intruded into the FDA decision-making, which is by law supposed to be based solely on scientific evidence.

The key findings of the GAO report were that the FDA did not employ its usual procedures and scientific standards in weighing the Plan B application. GAO investigator Marcia Crosse said it was unusual for top FDA officials to get actively involved. The decision to reject the application was signed by Steven Galson, the senior officer of the Center for Drug Evaluation and Research, because lower-ranking officials disagreed with his conclusion.

McClellan has said that his involvement with "Plan B" was "consistent with his usual practices."

Really? Were all his other actions at the FDA corrupt as well?

This story will surprise exactly nobody. But it is, nevertheless, outrageous.

Posted by James at November 15, 2005 8:05 AM
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So, will the light of day do anything to change this stupidity? Or does the old boys network win again?

Posted by: briwei at November 15, 2005 8:40 AM

Yep, that's our gov'mint at work. Science schmience. God is all we need!

Posted by: Patti M. at November 15, 2005 9:48 AM

No shit, huh?

From GAO calls contraceptive review process 'unusual' (World Peace Herald):

...Susan F. Wood, FDA assistant commissioner for women's health, quit in August, saying upon her resignation that she was tired of seeing scientific evidence on Plan B "overruled," and that such decisions were causing "fairly widespread concern about FDA's credibility" on contraception...
Posted by: Chuck S. at November 18, 2005 1:04 PM

I came across this this morning and shared it with Bob and James (From The Grey Sheet, which is an industry pub that covers medical devices, diagnostics, and instrumentation:

FDA proposes new latex condom labeling in a 1draft guidance and Federal Register notice posted on the agency's website Nov. 10. In 2000, Congress mandated FDA to reexamine condom labeling for medical accuracy, particularly with regard to the ability to provide protection from transmission of human papillomavirus (HPV). The labeling would indicate that latex condoms provide less protection for sexually transmitted diseases, such as HPV, which can be transmitted by contact with skin outside the area of condom coverage. But it would also note that condoms may provide some benefit in reducing the risk of HPV-related diseases, such as cervical cancer. Senator Tom Coburn (R-Okla.), who put a hold on Lester Crawford's nomination for FDA Commissioner in June because of FDA's delay in issuing the condom labeling guidelines, expressed dissatisfaction with the document. "The agency continues to promote inconclusive assurances that put women unknowingly at risk for cervical cancer, or worse," he said Nov. 10....

What's this really all about?

Lookee here:

Condom Label Flap Stirs Controversy
June 30, 2005


Clarifying what condoms do well is especially important right now, the experts said, because there is a growing support for abstinence-only programs that downplay the importance of condom use.

Spearheading that movement is Republican Sen. Tom Coburn, an Oklahoma doctor who in 2000 sponsored a bill requiring that the FDA mandate more specific, "medically accurate" condom labeling. That effort has also been supported by groups such as the abstinence-supporting Medical Institute for Sexual Health. On June 15, Coburn announced he would block the appointment of nominee Lester Crawford as new FDA commissioner until Crawford pledged to make these labeling changes -- a stance opposed by many at Wednesday's conference.

Reacting to critics who have charged that the senator's stance is part of a wider crusade against sex outside of marriage, Coburn's spokesman John Hart told the Associated Press Wednesday that the senator's only concern is that condom labeling be changed to state their "effectiveness or lack of effectiveness in preventing STDs."


Posted by: Patti M. at November 18, 2005 2:29 PM

Ugh. Wanker.

Posted by: James at November 18, 2005 3:23 PM


Posted by: Patti M. at November 18, 2005 3:27 PM


Posted by: Chuck S. at November 18, 2005 5:04 PM

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