CONSERVATIVES DECRY POLITICIZATION OF THE FDA

CONSERVATIVES DECRY POLITICIZATION OF THE FDA. Oh, this is rich: The Family Research Council and Concerned Women for America are suing the FDA over the agency's approval of Plan B emergency contraception for over-the-counter sale. Their complaint? The FDA's decision was politically motivated.

"It's very clearly caught up in political dynamics and I would go so far as to say there is electoral politics involved here," said [FRC's Charmaine] Yoest.

Indeed! I share Mrs. Yoest's assessment. In fact, women's rights advocates have been pursuing a lawsuit over the politicization of the Plan B decision since January 2005. They've subpoenaed White House officials, and depositions in the case have already revealed a lot about conservative politicians' meddling in the FDA approval process:

As far back as 2003, then-FDA commissioner Mark McClellan agreed to an unprecedented meeting with a White House domestic policy adviser to discuss the Plan B application. And Dr. Janet Woodcock (who also warned that Plan B would create teen sex cults) came right out and said Plan B shouldn't be sold over-the-counter to teens -- not because of the science but "to appease the administration's constituents."

Those constituents are folks like the FRC and CWA. You'd think they would be thrilled by political interference at the FDA. After all, medical research says emergency contraception is safe for women of all ages. Sadly for Yoest and her ilk, science isn't equally supportive of the claim that EC access leads to the formation of teen sex cults.

[The conservative groups'] lawsuit charges that the FDA had no authority to approve the same drug and labeling for simultaneous prescription-only and over-the-counter distribution and that the FDA cannot treat the drug differently based on the age of the buyer because "FDA lacks the authority to enforce Plan B's age limitations."

Here's another point on which I agree with the conservative groups. The FDA's decision to assign Plan B special "dual label" status -- over-the-counter for adults and behind-the-counter for teenagers -- was totally ridiculous. Thousands of pages of research said it was safe for women of all ages. And an independent advisory committee voted 27-1 to allow sale of Plan B over-the-counter with no age restriction. The conservative groups are correct that younger women can still access Plan B without a prescription (they're free to e-mail me; I'd happily purchase the drug for any woman under 18). Which makes it all the more apparent that labeling Plan B differently for sale to teens was not a practical or science-based decision, but a purely political one.

--Ann Friedman

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