In a surprising twist, the Obama administration has overruled the Food and Drug Administration and will not allow teenage girls to buy the emergency contraceptive Plan B One-Step without a prescription.
The decision punctuates one of the longest-running public health sagas in recent memory. The FDA had decided that a version of the morning-after emergency contraceptive pill could be sold without a prescription regardless of the age of the buyer.
As FDA Commissioner Margaret Hamburg said in a statement Wednesday:
"I reviewed and thoughtfully considered the data, clinical information, and analysis provided by [FDA's Center For Drug Evaluation and Research], and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential."
But Health and Human Services Secretary Kathleen Sebelius (Hamburg's boss) disagreed with the FDA's assessment in this memo. Sebelius wrote:
"Based on my review, I have concluded that the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages."
Sebelius told the FDA to tell the maker of the drug that its marketing application is "inadequate to support approval." In other words, its bid to sell Plan B to teens without a prescription has been officially rejected.
The present product, Plan B One-Step, didn't even exist when the FDA's advisory committees on over-the-counter medicines and reproductive health drugs voted 23-4 to recommend that the original, two-pill product, be made available without prescription to all age groups. The single-pill version was approved in 2009.
Both the original Plan B and Plan B One-Step contain the same ingredients as regular birth control pills, but in higher doses. They are highly effective at preventing pregnancy if taken within 72 hours of unprotected sex, but will not interrupt an already established pregnancy. They aren't the same as the abortion pill mifepristone.
The FDA, however, which normally follows the advice of its advisory committees, did not in the case of Plan B. As the months dragged on with no decision, women's health groups and Democratic women lawmakers on Capitol Hill accused the George W. Bush administration of playing politics with the issue.
Finally, in 2006, the FDA issued a split decision of sorts. It said Plan B could be sold to those over the age of 18 without a prescription, but younger women would need a doctor's permission first.
The FDA in 2009 ordered that age lowered to 17 to comply with a federal judge's order. And that's where it will remain.
Update 2:18 p.m.: Teva Pharmaceuticals, the maker of Plan B, commended FDA for recommending an easing of restrictions on over-the-counter access to the drug. "We are disappointed that at this late date, the Department of Health and Human Services has come to a different conclusion," Teva said in a statement. The company said it will determine its "next steps" after receiving the official letter from FDA on the decision.
LYNN NEARY, HOST:
In a surprise ruling, the Food and Drug Administration has rejected a request by the maker of a popular morning-after birth control pill to let it be sold without a prescription to women of all ages. Here's the surprise: the FDA commissioner, Margaret Hamburg, actually said she was convinced the product, called Plan B One-Step, is safe and effective enough to be sold over-the-counter to women and teens without any restriction on age.
But Hamburg was overruled by her boss, Health and Human Services Secretary Kathleen Sebelius.
Here to help us sort all this out is NPR's Julie Rovner, who's been covering this story since - how long, Julie?
JULIE ROVNER, BYLINE: Two thousand and three.
NEARY: Wow, that's a long time. Let's start with what this product is and what makes it so controversial.
ROVNER: Well, what it is, is a high dose of the ingredient in regular birth control pills. It used to be a two-pill regimen. This product is now only one, but both of them - when taken within 72 hours of unprotected sex - are highly effective at preventing pregnancy.
And I should add one thing this product is not is the abortion pill, known as RU-486, or mifepristone. But it is still controversial to some anti-abortion activists because one of the ways it's thought to work is by preventing a fertilized egg from implanting in a woman's uterus, which to some is equivalent to a very early abortion.
NEARY: So this fight over whether the pill should be available without a prescription, this fight has been going on for a long time, as we've said. What's holding it up? What's the sticking point?
ROVNER: Well, almost eight years ago this week, two advisory committees of the FDA said Plan B was safe and effective enough to be sold over-the-counter to women of all ages. The Bush administration, however, said there wasn't enough data on younger teens, how they might use it, and it turned down the application. Meanwhile, there are lots of accusations about political interference.
Eventually, there was sort of a compromise. In 2006, there was a decision in which FDA said that Plan B could be sold to women aged 18 and over without a prescription, but still only with a prescription to those 17 and younger. Later on, a federal judge lowered that by a year, so women 17 and older could get it without a prescription. Those 16 and younger still needed a prescription.
NEARY: All right. Well, how are people reacting to this news?
ROVNER: Well, everyone on both sides that the Obama administration would be a lot more sympathetic to the idea of making emergency contraception available over-the-counter to women of all ages, which is why it came as quite a surprise when Secretary Sebelius overruled the FDA.
I've been talking to women's health advocates this afternoon and they truly weren't expecting this. They point out that President Obama made a point of saying this administration was going to base its decisions on science and not on politics. And while the secretary did cite science in her letter, she worried about whether very young girls would be able to use the product properly. She talked about 11 and 12-year-olds.
But they point out that's not a standard that any other over-the-counter medication is held to. They also can't remember any other time that an HHS secretary has overruled the scientific opinion of the FDA on whether something is safe and effective.
NEARY: Julie, there's another sensitive contraceptive issue that's facing the Obama administration right now. Can you tell us about that one?
ROVNER: Yes, religious organizations, particularly the Catholic Church, want the administration to scale back rules under the new health law that will require them to provide contraceptives as part of their health insurance plans. They say it violates their religious freedom.
We don't know yet what the administration is going to decide to do. But it's expected to make a decision sometime soon.
NEARY: NPR's Julie Rovner. Thanks so much, Julie.
ROVNER: You're very welcome. Transcript provided by NPR, Copyright NPR.