FDA: Teens? What teens?

Perhaps we should trust the agency's commitment to OTC Plan B about as much as it trusts minors to make responsible decisions.


Lynn Harris
August 2, 2006 8:05PM (UTC)

So we know that Sens. Clinton and Murray are -- rightly -- blocking the confirmation vote on acting FDA chief Andrew von Eschenbach until we get a straight answer on over-the-counter availability of Plan B emergency contraception. They got hoodwinked last time with an empty promise, and are not about to be fooled again.

But wow, is this deal so not done. First of all, if you read the mostly-on-target New York Times editorial on the topic today, you might have come away thinking that the FDA's only eensy holdup at this point is figuring out how, in practice, to limit sales of the drug to women 18 and over.

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Hang on. Just, like, five minutes ago we were arguing that the very people who need easiest, fastest access to this drug are girls under 18. (You know, the ones who, once they get their hands on the drug, will form a nationwide network of teen sex cults.) Did no one notice that it was von Eschenbach himself who shifted the conversation, asking Barr to raise the age restriction in its application from 16 to 18, the "appropriate age" for OTC access? Since when is "appropriate" a medical term?

So. This over-18 plan: Good enough? In the words of the demographic the Times leaves out: Not. Of course, there's the question of expediency, of doing what it takes to get something out there for so many women who need it. But I'm not convinced that once -- that is, if -- they give us the inch, we'll really be able to go back for the yard.

Second, there's this, which the Times does point out, though USA Today puts it more strongly: "There's also reason to be skeptical of FDA's claim that it hopes to issue a decision within weeks. It warned Barr Laboratories, the marketer of Plan B, that unless it provides details on how the age restriction would be rigorously enforced at pharmacies, the pill will remain available only by prescription. Sounds like a potential excuse to reject Plan B -- after von Eschenbach is confirmed." Right. So Barr could say, "OK, so we'll put Plan B behind the pharmacy counter and require women who want to purchase it both to show I.D. and have their full name and that of their sex partner announced over the P.A. system." And the FDA could say, "Not bad, but we were hoping they'd also have to perform a number from the 'Phantom of the Opera.' Sorry, no go."

Sounds to me like they could be setting us up for another hoodwink. But hey, they've been making us wait since 2003. We should encourage our senators to let the FDA know that this time, we're holding out for the real deal.


Lynn Harris

Award-winning journalist Lynn Harris is author of the comic novel "Death by Chick Lit" and co-creator of BreakupGirl.net. She also writes for the New York Times, Glamour, and many others.

MORE FROM Lynn Harris

Related Topics ------------------------------------------

Birth Control Broadsheet Health Hillary Rodham Clinton Love And Sex Patty Murray, D-wash.

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