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Judge Orders FDA to Make Morning-After Pill Available to Females of All Ages

April 5, 2013 at 12:00 AM EST
A federal judge in New York struck down age limits for the contraceptive Plan B. The new ruling allows women of all ages to purchase the "morning-after pill" without a prescription. For more on the age restriction, the court decision and the debate, Jeffrey Brown talks to The Washington Post's Sarah Kliff.
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JEFFREY BROWN: It’s an issue that’s been fraught with moral, legal and political implications. And today came the latest step, as a federal judge in New York ordered the Food and Drug Administration to make the most common morning after pill available to women and girls of all ages without a prescription.

The ruling gives the FDA 30 days to lift the age restrictions on Teva Pharmaceutical’s Plan B One-Step and its generic form. Under current regulations, the emergency contraceptive, which reduces the risk of pregnancy by half if taken soon after unprotected sex, is only available over-the-counter to women 17 or older.

Younger teenagers must have a prescription. In 2011, the FDA concluded that Plan B One-Step was safe to sell to everyone without that requirement. But Health and Human Services Secretary Kathleen Sebelius overruled that decision, saying there wasn’t enough evidence to allow the contraceptive to be sold to girls younger than 17 without a doctor’s order.

Today, U.S. District Judge Edward Korman called that action “arbitrary, capricious, and unreasonable, an excuse to deprive the overwhelming majority of women of their rights to obtain contraceptives without unjustified and burdensome restrictions.”

In response, this afternoon in Washington, White House Press Secretary Jay Carney said the administration stands by its original decision.

JAY CARNEY, White House Press Secretary: Secretary Sebelius made this decision. The president supported that decision after she made it, and he supports that decision today. He believes it was the right commonsense approach to this issue.

JEFFREY BROWN: Today’s ruling is now being reviewed by the Justice Department.

More now about the ruling and the long debate surrounding this issue with Sarah Kliff of The Washington Post.

Sarah, strong language from that judge. Fill in a little bit about his arguing.

SARAH KLIFF, The Washington Post: Right.

I mean, he didn’t mince words in his ruling. He called it arbitrary, capricious, very much saw it as a political decision on the part of the Obama administration. And one of the things he relied on pretty heavily there was the fact that the FDA, after a rigorous review, decided this should be available over-the-counter, and that the HHS stepped in and said, you know, because of some of the concerns we have, citing not necessarily evidence of this being harmful for young girls, but saying we have concerns about young girls purchasing this, because they stepped in without that evidence.

JEFFREY BROWN: What was the evidence? What do they mean by evidence? It’s not the medical safety of the actual drug vs. how it would be used?

SARAH KLIFF: Right.

So, the FDA went through and they did a rigorous study, as they do with all medications, looking at, what are some of the side effects and possible harms if the medication is taken in a way it is not supposed to be? And they found it safe.

Secretary Sebelius in her statement overruling them said that there was no testing done on 11-year-old girls. And since there are some 11-year-old girls who have reached menstruation, that there is a possibility they could use it, and saying because there was no testing on that age group that they shouldn’t allow it to go over-the-counter was her argument about a year ago.

JEFFREY BROWN: That was a very controversial decision back then. Right?

SARAH KLIFF: It was.

JEFFREY BROWN: And that led directly to this lawsuit.

SARAH KLIFF: It was the first time an HHS secretary has ever overruled the FDA on a decision like this. So it was really a break from what we’re used to.

JEFFREY BROWN: At the same time, as I said in the intro, this has been steeped in politics for a long time, certainly at least going back to the George W. Bush administration, including a number of resignations along the way.

SARAH KLIFF: Right.

Ever since Plan B was first approved for sale as a prescription in 1999, it’s been marked with controversy. We saw, right, multiple officials resigned over the issue during the Bush administration. Many expected the Obama administration to quickly make Plan B available over-the-counter.

And many folks who were advocating it, right, were really surprised and disappointed with the decision in 2011 and are really excited about this court ruling right now.

JEFFREY BROWN: Well, tell me more about that. What kind of reactions were there today from both sides?

SARAH KLIFF: So, a lot of excitement from both medical groups and women’s health groups who have really been pushing the administration hard on this issue.

Some abortion opponents and social conservatives are very concerned about this ruling, that they say it will essentially remove parents and doctors from a decision that they should be involved in. And they’re very worried about, you know, what it will mean to have emergency contraceptive on a shelf next to, you know, Tylenol and other over-the-counter medications.

JEFFREY BROWN: HHS and the administration can presumably appeal. Any signals or signs of what the next step would be?

SARAH KLIFF: They are being pretty quiet right now. The Justice Department says — obviously, the ruling just came out this morning. They’re reviewing the options.

Press Secretary Jay Carney for the White House says they stand by their earlier decision, but hasn’t commented yet on whether the Department of Justice will pursue action to overturn this.

JEFFREY BROWN: Of course, the politics are still there, right, whichever way they go?

SARAH KLIFF: Yes. It is a tough decision.

And it’s kind of been a thorn in the side of two administrations at this point. The politics might be a little bit different than the last time they addressed this issue. They’re not facing reelection this time, which might give them a bit more wiggle room. But you are going to have some folks disappointed on both sides of the issue, no matter where you land.

JEFFREY BROWN: In the meantime, what is known at this point about how widely the pill is being used, how much it may have expanded, if at all, in recent years?

SARAH KLIFF: It’s pretty widely used.

The CDC looked at this a few years ago, and they found, between 2006 and 2010, that about one in nine women of child-bearing age — that works out to about 5.8 million women — used an emergency contraceptive. It is most frequently used by women 20 to 24, and most often used either once or twice.

You don’t see a lot of repeat use that some folks would worry about, relying on it as regular birth control. But it’s definitely pretty widely used, and there is some feeling that the Affordable Care Act, by eliminating co-pays for contraceptives, may increase the use in years going forward.

JEFFREY BROWN: And is there the expectation that this ruling, if it stands and isn’t appealed, that might affect the numbers, presumably?

SARAH KLIFF: Right, if it makes access easier.

One of the issues that has been raised here, while this affects minors a lot, in that they would no longer need a prescription, is that for women over 17, they’re not going to have to go to the pharmacist or go to the drugstore when the pharmacy is open. So that could really expand access to older women as well.

JEFFREY BROWN: Sarah Kliff from The Washington Post, thanks so much.

SARAH KLIFF: Thank you.