FDA OKs Prescription-Free Plan B Pill For Women 15 And Up

Apr 30, 2013

In an effort to find a compromise for a politically fraught issue, the Food and Drug Administration has approved a proposal to make the emergency contraceptive pill Plan B more available to some younger teens without a prescription and to older women by moving the medication out from behind the pharmacy counter.

But the proposal stops short of the full over-the-counter, no-age-restriction order issued April 5 by U.S. District Court Judge Edward Korman.

Korman gave the FDA 30 days to lift the existing restrictions on the sale of the morning-after pill. He said the Obama administration's failure to make the medication more fully available despite the recommendations of its own scientific staff was "arbitrary, capricious and unreasonable."

Instead, however, the agency approved a pending application from Teva Pharmaceuticals, which owns the patent for Plan B One-Step, to make the product easier to obtain.

Specifically, teenagers below 15 would now need a prescription to purchase the product. That age was previously 17. The proposal would also allow the product to be sold on retail shelves, rather than behind the pharmacy counters, with age to be verified by cashiers rather than pharmacy staff.

Previously, the need to keep the product behind the pharmacy counter has limited its availability to hours when pharmacies are open and has led to other difficulties in obtaining the pill, which works best when taken as soon as possible after unprotected sex.

Women's health groups were divided in their reaction to the administration's actions.

Planned Parenthood Federation of America President Cecile Richards called the move "an important step forward to expand access to emergency contraception and for preventing unintended pregnancy," though she added that "we continue to believe that the administration should lift all unnecessary restrictions to emergency contraception, consistent with the prevailing science and medicine."

Sen. Patty Murray, D-Wash., a longtime advocate for making the medication more widely available, likewise called the decision "a step in the right direction for increased access to a product that is a safe and effective method of preventing unintended pregnancies."

Other groups, however, were less pleased.

Nancy Northup, president of the Center for Reproductive Rights, one of the groups that brought the original lawsuit, said the FDA's actions are far from sufficient: "The FDA is under a federal court order that makes it crystal clear that emergency contraception must be made available over the counter, without restriction to women of all ages by next Monday."

And Marcia Greenberger, co-president of the National Women's Law Center, called the move "an improvement over current policy," but "still disappointing because by retaining an age restriction that the FDA had previously determined was unnecessary, women of all ages must surmount barriers to getting the morning-after pill."

Also unhappy were those groups who oppose all over-the-counter availability of the morning-after pill.

"Over-the-counter availability of Plan B for teens distances those girls at highest risk for sexual abuse and sexually transmitted infections from the medical supervision they need," said Anna Higgins of the Family Research Council. "If Plan B is available OTC, teens and women will avoid necessary medical screenings during which serious medical problems like STIs would be detected and treated."

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From NPR News, this is ALL THINGS CONSIDERED. I'm Audie Cornish.


And I'm Melissa Block.

There's news today of a decision by the Obama administration regarding the so-called morning-after pill. The administration has effectively announced it will not abide by a judge's ruling last month. The court ordered the pill had to made available without a prescription to women of all ages. Instead, today, the Food and Drug Administration is proposing that some limits on the drug remain.

NPR's Julie Rovner joins us to explain the latest. And, Julie, we're talking about the drug known as Plan B. Remind us what the status is right now.

JULIE ROVNER, BYLINE: Well, right now, the drug in question known as Plan B is available without a prescription to women age 17 and over and with a prescription to those who are younger. The problem, however, has been that because of the age requirement, and the fact that some people need a prescription and some people don't, the medication has been kept behind the pharmacy counter. That's led to it being less than easily available for older women. Obviously, they have to have a pharmacy open in order to get it.

And because the drug works better the sooner you take it after unprotected sex, having to wait to get it or having difficulties getting it has been very problematic.

BLOCK: We should explain this is emergency contraception we're talking about.

ROVNER: That's right, emergency contraceptive - the morning-after pill, as it's known.

BLOCK: And tell us more about the judge's ruling last month that I mentioned.

ROVNER: Well, this is U.S. District Court Judge Edward Korman. He's been overseeing this case, which is on behalf of several women's health groups versus the U.S. Department of Health and Human Services. It dates back to the Bush administration, actually, goes back to 2005. And what he ruled last month is that by preventing full over-the-counter sales of Plan B - meaning no age restrictions - the Department of Health and Human Services has acted in a manner that has been, quote, "arbitrary, capricious and unreasonable."

Basically, he said last month that the current secretary of Health and Human Services, Kathleen Sibelius, overrode the scientists at the Food and Drug Administration. They have said that the drug is completely safe enough to be available on pharmacy shelves for anyone to buy it.

BLOCK: So now, given the judge's ruling, what is the administration proposing?

ROVNER: Well, now the administration says that they would like to compromise. The FDA, as you mentioned, just approved the drug company's original application, which would be to lower the age where a teen would need a prescription to 15. So younger teens would still need to get a doctor's permission to obtain the drug.

But the compromise is apparently that the medication would not be kept behind the pharmacy counter anymore. It would be out on store shelves. Now, the press release from the FDA says it would be kept most likely in a family planning or female health aisles but obviously not restricted to there. That means it would be much more available for older women who've had difficulties getting it, but it would only be available in stores that have a pharmacy.

So you won't be able to get it at your local corner convenience store, just at a pharmacy or at a larger retail store that has a pharmacy, but not necessarily just when the pharmacy is open. So that's important, because one of the difficulties women have had is they say they will go to the Target or the Walmart, or whatever, but if the pharmacy counter is closed, they can't get the medication.

BLOCK: And just to be clear, if it were to be a younger teen, if the drug is available over-the-counter on the shelves, they would take it to check out and what, they would have to then show a prescription, or it would be up to the checkout person to ask the prescription?

ROVNER: That's right. They would have to show a prescription or - and/or they would have to show ID. You will still have to show ID, proof of age, in order to purchase it.

BLOCK: Well, what happens now, Julie? Does this satisfy the judge's ruling, or does it get bounced back to the court? What happens?

ROVNER: No. Clearly, this is not what the judge has in mind. So the Justice Department has not formally said that they're going to appeal. But clearly, they will have to. They will have to ask for a stay because the judge gave the FDA 30 days to make it available fully over-the-counter.

So I imagine that we will see in the next couple of days, because the 30 days is almost up, something from the Justice Department making it official that they will not be abiding by the judge's ruling and asking for a stay and some sort of formal appeal of this ruling. That's not going to make these women's health groups, who originally filed this lawsuit, very happy.

BLOCK: OK. NPR health policy correspondent Julie Rovner. Julie, thank you.

ROVNER: Thank you.

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