Experts not behind reversal on Plan B (Politics!)

[leftchick]

http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/06/18/MNG7V78AGB1.DTL

<snip>
Washington -- Just days before the Food and Drug Administration rejected an application to make the emergency contraceptive Plan B available without a prescription, top FDA scientists dismissed the reasoning that was used to justify the rejection as unfounded, internal agency documents reveal.

The documents, which contain the scientific conclusions of three separate levels of FDA reviewers, show that the scientists disagreed in particular with the contention that there was insufficient information to assess how easier availability of the drug would affect the sexual behavior of young teenagers. That was the primary reason given for the FDA's dismissal of the application as "non-approvable."

One top official wrote that by raising the issue of teenage use, former Commissioner Mark McClellan and Center for Drug Evaluation and Research acting director Steven Galson appeared to be introducing a different standard for evaluating Plan B than the FDA had applied to other contraceptives.

"The agency has not (previously) distinguished the safety and efficacy of Plan B and other forms of hormonal contraception among different ages of women of childbearing potential, and I am not aware of any compelling scientific reason for such a distinction in this case," wrote John Jenkins, director of the FDA's Office of New Drugs, which oversees all drug reviews for the agency

[struggle4progress]

1. kick

:kick:

[jdj]

2. Scott's brother.

evil is in the DNA I guess.

One the same day that they found the infant in the portable toilet.

These folks have been festering undetected in America as an organized front for 25 years, and now we have a diagnosis. America has a malignancy, and we need surgery to cut these fundies the hell out of positions of power.