'Plan B' Gets FDA's Over-Counter Approval

Robert Siegel talks with NPR's Julie Rovner about the Food and Drug Administration's decision to approve sales of the so-called morning-after pill without a prescription. The new rules allow women over 18 to buy the "Plan B" drug over the counter. The decision comes after three years of national debate over access to emergency contraception.

Copyright © 2006 NPR. For personal, noncommercial use only. See Terms of Use. For other uses, prior permission required.

ROBERT SIEGEL, host:

This is ALL THINGS CONSIDERED from NPR News. I'm Robert Siegel.

The Food and Drug Administration today approved the sale of Plan B, the morning after contraceptive pill, without a prescription but only to those 18 and over. Younger teenagers will still need a doctor's prescription to access the drug. The emergency contraceptive can prevent most pregnancies if taken within 72 hours of unprotected sex.

The FDA's decision caps a three-year fight over teen sex, abortion and the intersection of science and politics. And with us by phone to discuss today's announcement is NPR's Julie Rovner, who's followed this fight from the beginning.

Julia, let's start with today's announcement. Obviously, with this drug, the sooner you take it the better. So how much easier will this make it?

JULIA ROVNER reporting:

Well, yes. Obviously time is of the essence and that's the main reason for this push to make it available without prescription. The drug can actually work for up to five days but it's most effective if taken within 24 hours of unprotected sex. Now what the FDA has done today will make it somewhat easier to get the pill quickly, but not as easy as perhaps other over the counter medications.

It won't, for example, be sold in convenience stores or in grocery stores that don't have pharmacies. In fact, it will only be sold in places where there is a healthcare professional on duty, which would mean pharmacies or health clinics.

And it will be kept not out but behind the pharmacy counter so you can only get it when the pharmacy counter is open, and you can only get it if the pharmacist is willing to sell it to you. And which we've seen over the last year or two, there are a small but growing number of pharmacists who have moral objections to this medication. They say that it can cause very early abortion, even though it is not the abortion pill. It is considered a contraceptive by the FDA. So it will make it easier but it will not take down all of the barriers.

SIEGEL: But apart from that argument about abortion, there were other objections that were made against making the drug more easily available, no?

ROVNER: Yes. The most common objection and what really has been holding this up for the last couple of years is this discussion about what to do about teenagers. There were people who were worried that teenagers might use this instead of birth control that does need a prescription, which seems unlikely since it costs $30 for these two pills that make up emergency contraception.

There was also concerns that teens might, if they know that they could take a drug after they have unprotected sex they might be more likely to do that. But in fact, this drug is available over the counter in more than 40 other countries. There have been a number of studies done and it turns out that that's simply not been the case.

SIEGEL: Now, we heard for some time now that this has not been a scientific decision that was made today, but rather there was political pressure from conservatives that stalled approval of Plan B. What then can we conclude from today's announcement that it's going to be approved over the counter for those 18 and over?

ROVNER: Well, I think the main thing we can conclude from today's announcement is that the White House would like to get its latest commissioner for the Food and Drug Administration approved. That would be Andrew von Eschenbach. He had his confirmation hearing last month, and Senators Hillary Rodham Clinton and Patty Murray, two Democrats, said that they would not allow a vote on his nomination until the FDA made a decision up or down on this.

Now they had said the same thing last year when there was a previous commissioner up for the head of FDA and they were promised a decision and they basically relented and let that commissioner be approved, and then the FDA put it off again. So this time they said they will absolutely not allow a vote until this happens.

So this has now happened. They have said today in a conference call that they will lift that hold and allow von Eschenbach to be approved to head the agency.

But I think beyond that, the decision really still leaves open the question of whether in fact it is based on science. In the memo that accompanied the decision, Dr. von Eschenbach said that he chose age 18 because that's what most states use for other restricted but legal products, like tobacco.

But in fact, the scientists at the Food and Drug Administration had earlier concluded they thought it could be safely used by girls age 17, some of them by age 16. Two FDA advisory committees said that they thought it was safe and effective and should be approved without an age restriction.

SIEGEL: Julie, just very briefly, what else if anything in a pharmacy is available over the counter for those over 18 but only by prescription for those under 18?

ROVNER: Well, certainly nicotine patches and lozenges and gum, things to stop smoking are available only to those over 18 without a prescription, but again, that's because tobacco is available only to those over age 18. These days, also Sudafed, some of the drugs that can be used to make methamphetamine - are restricted to those over age 18.

SIEGEL: That's NPR's Julie Rovner. Julie, thanks for talking with us today.

ROVNER: Thank you.

SIEGEL: And you can learn more about how Plan B works at our website, NPR.org.

Copyright © 2006 NPR. All rights reserved. No quotes from the materials contained herein may be used in any media without attribution to NPR. This transcript is provided for personal, noncommercial use only, pursuant to our Terms of Use. Any other use requires NPR's prior permission. Visit our permissions page for further information.

NPR transcripts are created on a rush deadline by a contractor for NPR, and accuracy and availability may vary. This text may not be in its final form and may be updated or revised in the future. Please be aware that the authoritative record of NPR's programming is the audio.

How Plan B Works

Emergency contraception is available in several forms. The most effective, according to the Association of Reproductive Health Professionals, are those that contain a single female hormone, progestin. Two progestin-only pills are sold in the United States: Plan B and Ovrette. Only Plan B is specifically marketed for use as emergency contraception, but either can be used.

The active ingredient in Plan B and Ovrette, progestin, is one of the hormones commonly found in standard birth-control pills. However, Plan B contains a higher dose of progestin than a standard birth-control pill.

Plan B comes in a two-dose package. One pill is taken 12 hours after the first. To get protection with Ovrette, 40 of the "minipills" must be taken to equal the dose of progestin found in Plan B. Whichever is chosen, the sooner you take the pills, the lower your odds of getting pregnant.

Plan B recommends that to obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of unprotected intercourse.

Another type of emergency contraception uses a combination of two female hormones: estrogen and progestin. Outside the United States, this combination is packaged for sale as emergency contraception.

In the United States, doctors must prescribe regular estrogen/progestin birth-control pills (only certain kinds work for emergency use) and instruct teens and adults on how to take them.

Use of this type of emergency contraception reduces the odds of getting pregnant by 75 percent. As the ARHP Web site Not-2-Late.com explains, this doesn't mean that 25 percent of women using estrogen/progestin combinations will become pregnant.

"Rather, if 100 women had unprotected intercourse once during the second or third week of their cycle, about eight would become pregnant," according to the site.

Following treatment with an estrogen/progestin combination, only two women would become pregnant. In other words, a 75 percent reduction in the odds of becoming pregnant.

One of the controversies that surrounds this topic is the way these pills work inside the body.

Opponents of abortion rights say that the pills sometimes work to prevent the implantation of a fertilized egg into the uterus. They consider this action to be the same as an abortion. This raises the issue of when a pregnancy actually starts.

The U.S. government and leading medical societies define pregnancy as beginning at implantation, not fertilization. Other contraceptives also work by preventing implantation of fertilized eggs, blocking fertilization or inhibiting ovulation.

Emergency contraceptives are not to be confused with the so-called "abortion pill," RU-486, sold under the brand name Mifeprex. Mifeprex can only be used after a pregnancy has been established.

Comments

 

Please keep your community civil. All comments must follow the NPR.org Community rules and terms of use, and will be moderated prior to posting. NPR reserves the right to use the comments we receive, in whole or in part, and to use the commenter's name and location, in any medium. See also the Terms of Use, Privacy Policy and Community FAQ.