If I wasn't already on the evil daily abortifacient

I'd go have some casual sex to celebrate (since I could, theoretically, get some Plan B by prescription).

I guess I'll just piggypanda-back on Amanda, who gleefully passed on the news that Dr. W. David "don't mind my dick up your ass" Hager will will no longer be on the FDA’s Reproductive Health Drugs Advisory Committee as of July 1st. This is a pretty sweet thing after yesterday's big news that a puffed up Hager proudly announced his extraordinary pull with the FDA that the agency requested him to write an unheard of "minority opinion" that would justify nixing Barr Pharmaceutical's filed Rx-to-OTC switch for Plan B despite the fact the advisory board overwhelmingly voted to approve the switch (Hager was one for 4 naysayers compared to 23 experts who thought the application should be approved). According to a videotape obtained (and reported) by the maganize the Nation (and media outlets everywhere), Hager told attendees at a speaking engagement at Asbery College [emphasis added]:

"I was asked to write a minority opinion that was sent to the commissioner of the FDA. For only the second time in five decades, the FDA did not abide by its advisory committee opinion, and the measure was rejected."

Hager told the group that he had not written his report from an "evangelical Christian perspective," but from a scientific one -- arguing that the panel had too little information on how easier availability of Plan B would affect girls younger than 16. The FDA later cited that lack of information as the reason it rejected the application.

"I argued from a scientific perspective, and God took that information, and he used it through this minority report to influence the decision," Hager said. "Once again, what Satan meant for evil, God turned into good."

An FDA spokesperson verified that not only was Hager bearing "false witness" when he said the agency itself requested his minority opinion, she verified that the agency doesn't request minority reports/opinions at all and nobody at the FDA asked him to write his private citizen letter. Hager himself pointed out (see emphasized language above) that he'd written his letter from a scientific perspective (no offense to social scientists) but made it clear that, if his opinion was what swayed the decision, the Not Approval response the FDA sent to Barr was based not on any actual Clinical/Medical science but based purely on conjecture of possible behavioral of girls under 16 (who, like females over the age of 16, can legally obtain the drug with a valid prescription). This lends some pretty significant credence to concerns expressed by Senators Hilary Clinton (D-NY) & Patty Murray (D-WA), who have asked for an investigation into allegations that FDA decisions about the application have been based on politics, not science and/or medicine.

PDUFA ran out on a re-submission of Plan B ("behind the counter"; OTC for women 16 and older and by prescription for younger girls) last December, but 6 months later no decision appears forthcoming. Clinton & Murray have vowed block the nomination of Acting FDA Commissioner Lester Crawford as permanent commissioner until the agency finally rules on the current application of Plan B (just this past Monday, the Pink Sheet announced a vote would be set in the next couple weeks). They're not the only Senators who've expressed concern about Crawford and the Plan B debacle, Charles Grassley (R-IA) is not fan of the FDA's bullshit either (he's none too pleased with Crawford's lack of candor either).


Tags:FDA; contraception; healthcare; politics

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