I'm a huge fan of PlanB the morning-after contraceptive. Some of you know this because I ranted about this before.
Instapundit this morning was complaining about the FDA's disapproval of PlanB for non-prescription use. So how come I've never ripped the Bush Administration a new one for not approving it? After all, this could hugely cut down on the number of abortions in this country. It should be win-win?
Because it turns out there's blame enough to go around. What the articles Instapundit linked to don't tell you is that when Barr Pharmaceuticals took over marketing of Plan B from the WCC, they changed the application to allow it to be marketed to girls as young as 15.
Here in Arizona, that's known as shooting yourself in the foot. Of course, its more complex than that.
Here's where Barr shoots themselves in the foot (from the GAO report):
October 9, 2003: At the request of Barr Pharmaceuticals, Inc., a teleconference was held to discuss the upcoming joint public meeting of FDA’s advisory committees. Meeting participants from FDA included review staff within the Offices of Drug Evaluation III and V. According to teleconference minutes, review staff asked Barr Pharmaceuticals, Inc., about possible age restrictions for use of Plan B. Minutes also noted that Barr Pharmaceuticals, Inc., said that it intended to offer its product to women as young as 15 years of age. Also, Barr Pharmaceuticals, Inc., agreed to explore and report back to FDA on behind-the-counter marketing and the implementation of age limitations on the sale of Plan B.
This caused the FDA to worry:
January 23, 2004 ...meeting minutes noted that FDA officials told the sponsor that the Office of the Commissioner and the Acting Director of CDER had raised concerns as to whether there were adequate data to establish that minors (i.e., those under 18 years of age) would use Plan B appropriately in the absence of a learned intermediary. Potential options that were suggested from FDA and CDER management included the possible need to (1) collect additional data, perhaps from another actual use study targeted to minors, or (2) to impose an age restriction on the OTC sale of the product.
Basically, the FDA really, really, wanted to get the message across to teenage girls that this was emergency contraception (only 75% effective).
Barr senses which way the wind blows, and:
March 11, 2004 Barr Pharmaceuticals, Inc., submitted an amendment to its sNDA, proposing a dual-marketing strategy, making Plan B OTC for women 16 years of age and older and prescription only for women under 16 years of age.
But its too late:
May 6, 2004 FDA issued a not-approvable letter, denying Plan B OTC marketing status, citing a lack of adequate data regarding safe use among younger adolescents. The letter also stated that FDA was not able to conduct a complete review of the dual-marketing strategy in the amendment to the sNDA because of the absence of the draft product labeling describing how Barr Pharmaceuticals, Inc., would comply with both the prescription and OTC labeling requirements in a single package.
So what do I think?
First, the FDA should approve Plan B. But then again, I take weird not-approved-by-the-FDA Chinese Herbs for my health, so what do I know? I think the FDA is a total waste in general; this issue didn't exactly change my mind.
Second, Barr Pharmaceuticals should include a condom in each box labeled “for next time, idiot”.
Third, perhaps it should be behind the counter at the pharmacy, but without age restrictions.
Fourth, I agree with the director that teenage girls are idiots. I'm not sure that's science though, just informed observation. I don't think not having this drug available over the counter would help that problem though...
As for the blame? I blame the idiot who came up with the idea of the FDA in the first place... Exactly why do women need a prescription for birth control pills in the first place?
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