FDA Promises Movement on 'Morning-After' Pill
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From NPR News, this is ALL THINGS CONSIDERED. I'm Melissa Block.
MICHELE NORRIS, host:
And I'm Michele Norris.
Today the Food and Drug Administration suggested that it might be nearing a decision on whether to allow the over-the-counter sales of the morning-after contraceptive pill. Backers of easier access to the drug say it's just another stalling tactic in a fight that's been based more on politics than science.
NPR's Julie Rovner reports.
JULIE ROVNER reporting:
Plan B consists of high doses of regular birth control pills that can prevent most unintended pregnancies if taken within 72 hours of unprotected sex. Three years ago, its manufacturer asked FDA for permission to sell it without a prescription. FDA originally said no, that it was worried about Plan B used by young teens.
So the drug's maker, Barr Pharmaceuticals, suggested allowing over the counter sales to adults and older teens, but requiring those under age 16 to get a prescription. FDA was supposed to rule on that last August, but instead it sought public comment. Today, the FDA sent a letter to Barr saying -
Ms. SUSAN BRO (Food and Drug Administration): We believe there's a framework for resolving the outstanding policy issues associated with making this treatment available over the counter.
ROVNER: Susan Bro is a spokeswoman for the FDA. The letter asks the manufacturer to meet with FDA officials to discuss the possibility of allowing sales without prescriptions only to those age 18 and over. FDA officials also want to talk about how the prescription requirement would be enforced for younger teens. Bro concedes the timing of the letter - just 24 hours before acting FDA commissioner Andrew von Eschenbach goes before a Senate confirmation hearing - is no coincidence.
Ms. BRO: We knew and the acting commissioner knew that is was going to be very important to be able to talk about and answer some of the questions and share the observations he's made over the last several months with Congress tomorrow and provide a framework, which he is able to do.
ROVNER: But backers of easier availability to the drug say that even with the new letter, FDA really hasn't moved very far at all. Kirsten Moore is president of the Reproductive Health Technologies Project.
Ms. KIRSTEN MOORE (Reproductive Health Technologies Project): Anybody who's been involved with this application for, you know, a year or longer knows that this is just their latest ploy to make it look like their trying to do something, but at the same time holding the door open to not doing anything.
ROVNER: Opponents of the drug say easier availability could encourage teens to have sex. And some anti-abortion groups say Plan B could act to prevent implantation of a fertilized egg, thus making, it in their view, an abortifation, rather than a contraceptive. Moore disagrees.
Ms. MOORE: Making this product more widely available could greatly reduce the risk of unintended pregnancy and the need for abortion. That is a good thing. That's what they should be focused on promoting. Not how do we limit access to this product.
ROVNER: Still, if the FDA's letter was intended to get senators blocking von Eschenbach's nomination to back off, it's not working. Democrats Hillary Rodham Clinton of New York and Patty Murray of Washington call today's actions “more smoke and mirrors,” and renewed their vows to block a vote to confirm von Eschenbach until the FDA gives a yes or no answer on Plan B.
Julie Rovner, NPR News, Washington.
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