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Out of Legal Options, Justice Department Drops Fight on Morning-After Pill

June 11, 2013 at 12:00 AM EDT
The Justice Department reversed its stance on age-restricted access to the emergency contraceptive known as the morning-after pill. Plan B One-Step will now be available to females of all ages without a prescription. NPR's Julie Rovner joins Judy Woodruff to examine the decision.
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JUDY WOODRUFF: Now, what’s behind the decision to make the morning-after pill more widely available?

The battle over access dates back years, but has been fought in court most recently by the Obama administration. In 2011, the Food and Drug Administration decided the most popular form of the drug, Plan B One-Step, should be available to all girls and women without prescription. But Health and Human Services Secretary Kathleen Sebelius overruled the agency, keeping the age limit at 17 and above.

This spring, a federal judge ordered that that restriction be lifted. After the Justice Department indicated that it would continue to battle in court, the administration said for the first time Monday that it will not fight that decision.

Julie Rovner of NPR joins us again.

Welcome back to the NewsHour.

JULIE ROVNER, National Public Radio: Nice to be here.

JUDY WOODRUFF: So, why is the Obama administration changing its position on this?

JULIE ROVNER: Well, basically, it ran out of legal options. There was an appeals court ruling last week that said that the administration could not have a stay of that judge’s order from April on all forms of this medication.

So basically while this appeal was being heard, which was in the last several months, at least one form of this medication, the two-pill version, which is the original version of Plan B, as it’s called, would have to be available immediately on the shelves with no age limit. And the administration found that sort of untenable. So they have basically gone back and said to the judge, the original judge, that if it’s OK with him, that Plan B One-Step, the original pill, they would make that available without age restrictions, but they will not make the two-pill version available without age restrictions.

JUDY WOODRUFF: But the pill that will be, as you say, One-Step, one pill, and that’s it — that’s all a person would need to do.

So what does that mean? What’s going to be available and how soon is it going to be available?

JULIE ROVNER: Well, that’s not entirely clear.

That is of course the question everybody is asking today. There’s a couple of things that have to happen first. First of all, the judge will have to say that that is OK with him. Remember, this was not his original order. Originally, he wanted all versions of this medication be made available without restriction on the pharmacy counter — on the pharmacy shelves — excuse me.

So the judge will have to say that that is all right with him. If it is, then the company that makes that drug will have to apply to the FDA for a new label to say that it’s available to women regardless of age. The FDA will have to approve that, which they have said they will do almost immediately. That’s what they have said. Without delay were their exact words, and then it would have to be approved.

And then it would become available. The speculation is that that might take perhaps a month, but no one knows for sure exactly how long that would be.

JUDY WOODRUFF: So, over the counter, Julie, and how much is it expected to cost?

JULIE ROVNER: Well, and this is the rub. Plan B One-Step is the one brand-name drug of this class of drugs. It costs between $40 and $50 dollars, which is …

JUDY WOODRUFF: For one dose.

JULIE ROVNER: For one dose.

Now, it’s important if you have had unprotected sex, you’re worried about getting pregnant, that’s perhaps not so much to spend to prevent an unwanted pregnancy. The generic version to this drug, though, costs considerably less, usually $10, $20, perhaps as much as $30 dollars less.

According what the administration is proposing, those will not be available on the pharmacy shelves without age restrictions. So women’s health groups are not very happy about that.

JUDY WOODRUFF: So what reaction are you hearing? You have talked to women’s health groups. You have talked to folks on the other side. What are they saying?

JULIE ROVNER: Well, of course, Women’s health groups, as I mentioned, are not that happy that the generics will not be included in this, or at least it seems they will not be.

JUDY WOODRUFF: Because that means they would be less expensive and thus more …

JULIE ROVNER: Exactly. There would be more competition.

Some of the conservative groups who didn’t want it available without prescription at all obviously are not happy. They are not happy the administration gave up the fight. So, basically, it’s not clear who is happy with this. I think the Justice Department isn’t very happy because they wanted to appeal, but they, as I mentioned, kind of ran out of legal rope there.

It looked like, from what the appeals court did, that they were going to lose. So I think they basically had to go back and kind of sue for peace.

JUDY WOODRUFF: Who is believed will — which women is it believed will take advantage of this, age group? I mean, have there been studies done? Is there informed speculation about what the reaction to this is going to be?

JULIE ROVNER: There has been all this talk about teenagers, and particularly young teenagers.

One of the reason there is so little data on young teenagers is that it is not really thought that it is going to be used that much by young teenagers. The real issue with how this has been split, where it has been available by prescription for teenagers and without prescription for older women, is that by having it behind the counter, so everyone has had to ask for it, it has been difficult for women to get it.

They have had to go only when pharmacies are open. They have had to show I.D., and a lot of women, low-income women, immigrant women, people don’t — some women don’t have I.D. So even if they are obviously not teenagers, they have had difficulty getting it. And that is one of the issues about having it available it on the shelves, not having to show I.D. is for women who need it, not necessarily teenagers, to be able to get the product.

JUDY WOODRUFF: Women older — meaning women of age.

JULIE ROVNER: Yes, women of age.

JUDY WOODRUFF: Child-bearing age.

JULIE ROVNER: Yes, child-bearing age, not necessarily these young teenagers that everyone has been so concerned about.

JUDY WOODRUFF: But it is interesting you bring that up, because we happen to know that teen birth rates have been dropping dramatically over the last couple of decades, but you’re saying that that really isn’t the focus here so much.

JULIE ROVNER: That isn’t, although I will say that the American Academy of Pediatrics, the American Congress of Obstetricians and Gynecologists have all said that from everything they know from all the studies they have seen, teenagers and young — some young teenagers, to the extent we have data, do understand how to use it and understand that it is not to be used in place of regular birth control.

So it is not a matter that they can’t use it. It is just they are not expected to be the focus of who will use it with these lifted restrictions.

JUDY WOODRUFF: And just finally, Julie, you were just showing me this has been an issue for well over a decade. Scientists have been saying, you said from the beginning, almost, that this is a safe medication.

JULIE ROVNER: Yes.

In 2003, two advisory committees for the FDA voted overwhelmingly that it is — this was when there was only the two-pill product — that it was safe to be used and that it was safe enough for women of all ages, for this to be sold over the counter without age restrictions. So it’s really been a political fight through two administrations now.

JUDY WOODRUFF: Politics, hmm, isn’t that a surprise?

JUDY WOODRUFF: Julie Rovner of NPR, thank you very much.

JULIE ROVNER: Thank you.