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Justice Department Plans Fight Over Federal Ruling on Morning-After Pill

May 2, 2013 at 12:00 AM EST
The battle continues over the emergency contraceptive known as the morning-after pill, as the Justice Department announced it would appeal a federal ruling. A judge had ordered the age restriction be lifted so females of all ages could get the pill without a prescription. Jeffrey Brown talks with NPR's Julie Rovner.
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TRANSCRIPT

JEFFREY BROWN: And we return to the battle over emergency contraception, the so-called morning after pill.

It’s been more than a decade since the pill was first approved by the FDA, but legal and political controversy has swirled ever since. In 2011, the FDA decided the drug should be available to all girls and women, without prescription.

In an unprecedented action, Health and Human Services Secretary Kathleen Sebelius quickly overruled the agency, keeping the age limit at 17 and older.

Last month, a federal judge ordered that restriction lifted in a strong rebuke to the administration.

And then, on Tuesday, the FDA set a new age limit, 15 and older, for the most popular version of the pill, known as Plan B One-Step. And last night, the Department of Justice said it will fight the federal judge’s broader decision that the drug should be available to all girls and women.

Julie Rovner of NPR is here to help sort it all out.

And I hope you will, because it’s complicated. Welcome back.

JULIE ROVNER, National Public Radio: Thank you.

JEFFREY BROWN: First, the latest decision from the Department of Justice, appealing the ruling by the judge, why? What are they saying?

JULIE ROVNER: Well, this is more of a process appeal, not so much a substance appeal.

They’re saying the judge overstepped his abilities, that this has more to do with the way the FDA does its approval of drugs, and that he really — the judge really didn’t have the authority to order all drugs, that this was really simply about this one drug, the Plan B One-Step, and that really that he didn’t — he wasn’t able to do what it is that he’s trying to do, which is order all emergency contraceptives to be made available over the counter to women of all ages.

JEFFREY BROWN: And not only did he do that, but he did that in a very forceful way.

JULIE ROVNER: Yes, he did.

JEFFREY BROWN: A very — put-down against the administration.

JULIE ROVNER: He did, indeed.

This has been going on since 2005. This judge has had this case before it through two administrations now, and he said that — so he had strongly rebuked the Bush administration before and the Obama administration now for really sitting on this issue.

JEFFREY BROWN: OK, now, in the meantime this week, also, the FDA comes out with a — yet a new plan, a sort of compromise? Or how did — what are they doing?

JULIE ROVNER: You know, they had this had nothing to do with the judge’s order, but it’s really hard to square that with the fact that they had been sitting on this drug application from the pharmaceutical company, Teva Pharmaceutical, since 2011.

So — and yet it comes four days before the deadline to act. And it did, as you mentioned, reduce the age of — for people who do have to have a prescription down to 14, basically, so people, women 15 and up could get it without a prescription.

Something very important, though, that would change also under what the FDA did, before, because there was this split ruling where some people had to have a prescription and some didn’t, you had to get the product from behind the pharmacy counter. You had to go and ask someone at the pharmacy, either the pharmacist or a pharmacy clerk for it, which meant you could only get it when the pharmacy was open. You had to show I.D.

Now they’re saying that it can be sold on the shelves of retail stores that have pharmacies. So, you won’t be able to get it at a convenience store, but you will be able to get it at a Target, or a Wal-Mart, or a grocery store that has a pharmacy. So, that will make it more available.

But, still, you will have to show I.D. to a cashier. There will be literally a chip embedded that when you go to ring it up, it will tell the cashier, I.D. must be shown and you must be 15 or older.

JEFFREY BROWN: Now, as we heard in Judy’s segment, the president is in Mexico. He’s speaking right now at a press conference. And so I’m just seeing that he was asked about this. And he said, “I’m comfortable with the FDA decision allowing girls 15 and up to buy the pill.”

Now, that’s an interesting question, because it’s not clear, quite clear. The FDA is over here, the Department of Justice over here. The administration is over here.

JULIE ROVNER: Well, that’s not really a surprise, because, remember, when the FDA wanted to take off all the age restrictions, they were overruled by Sec. Sebelius, who said she was uncomfortable with taking off the age restrictions because of very young teenagers. And by very young, she said there wasn’t enough information on perhaps the 13- and 14-year-olds.

She was immediately backed up by the president, who, remember, has two young teenagers of his own, and I think there was concern about those very young teens. So I’m not surprised that both the president and presumably Sec. Sebelius, who we haven’t heard from, would be comfortable with 15 and up. Now, the concern that women’s health groups have about this is that these 15- and 16-year-olds, who this has now been extended to, a lot of them won’t have I.D.

Remember, they’re mostly too young to drive. They said they can present a passport or a birth certificate. It’s unlikely that that’s something that they will be walking around with either.

JEFFREY BROWN: Yes.

Well, as we said, this has been politically fought for a long time, so where does that leave the politics right now? Who is happy and who is not happy? Is anybody happy?

JULIE ROVNER: I don’t think anybody is happy.

JEFFREY BROWN: Right.

JULIE ROVNER: I think the people who really didn’t want this to be made more available, some of the more conservative Christian groups, don’t like it at all. The women’s health groups want all of the restrictions removed.

The administration sort of wants no part of this. And, remember, you have now got the Justice Department representing the FDA. Well, we know that the FDA’s position was originally to remove all restrictions.

So, it’s really hard to know who wants what right now.

JEFFREY BROWN: And what does happen next?

JULIE ROVNER: Well, they go before the judge. The judge has just given a few extra days to argue about whether or not they will get a stay in this order.

Remember, the judge has ordered the FDA to remove all restrictions, originally by next Monday. So now they’re going to argue about whether or not the judge is going to stay this order while this is being appealed.

JEFFREY BROWN: And let me just ask you briefly, do we know — in the meantime, the use of the morning after pill, do we know, is it growing? Has it stabilized?

JULIE ROVNER: There has been some more use, but, again, there have been these barriers, as I mentioned, not just for younger women, but for older women who have had trouble getting it because it’s been kept behind the pharmacy counter, and there have been difficulties with it.

JEFFREY BROWN: All right, Julie Rovner of NPR, thanks so much.

JULIE ROVNER: Thank you.