FDA Approves Non-Prescription Morning-After Pill
STEVE INSKEEP, host:
It's MORNING EDITION from NPR News. I'm Steve Inskeep.
RENEE MONTAGNE, host:
And I'm Renee Montagne, good morning. The Food and Drug Administration today approved over-the-counter sales of the morning after pill to those 18 and older. The FDA's decision ends a contentious three-year effort by the drug's manufacturer - as well as advocates of the pill - to make it available to both teenage girls and women without a prescription. However, the FDA will require girls 17 and younger to have a doctor's prescription to obtain the pills. Joining me on the line to talk about the decision is NPR's Julie Rovner. And Julie, why is the FDA allowing this drug to be sold without a prescription, but only to those over 18?
JULIE ROVNER reporting:
Well, they see this as a compromise. The official reason is that they are not convinced that it could be used as effectively by those younger than age 18. But I must add quickly, that was not the finding of either of the FDA's own advisory committees - which voted overwhelmingly to make it available over-the-counter to those of any age - nor its senior scientists who seem to coalesce around an age of either 16 or 17, that probably 16 and 17 year olds could use this safely without a doctor's prescription. This issue has, obviously, as you mentioned, it's been going on for three years. It has now plagued the confirmation - slowed the confirmation of three different FDA commissioners. And the latest FDA nominee suggested 18 at his confirmation hearing last month.
MONTAGNE: Now, critics have said that the FDA has stalled on this approval for political reasons. How political is this?
ROVNER: It's been extremely political. There's really sort of two different political issues here. One is that there's a small minority of anti-abortion activists who believe that this pill can act as a very early abortion. Now, the FDA does classify it as a contraceptive. The FDA officials said again this morning that they think that it acts primarily by stopping ovulation, although there is some thought that it could prevent a fertilized egg from being implanted. And there are those who consider that to be an abortion.
This is not the same as the abortion pill RU-486. But there is that small subset who does not approve of this pill in any case. Then there's sort a broader group who worries about the idea of teenage girls being able to get this pill - the morning after pill - easily will encourage them to have more unsafe sex. Now there have been several studies on this. There actually is no evidence that that's the case, but there is still some concern about teenagers having easier access to this.
MONTAGNE: So looking ahead, does this FDA decision mean that women over 18 can get the drug any time?
ROVNER: Well, yes and no. It means that they can skip a step, that women over 18 will no longer have to go to a doctor and get a prescription. But they'll still have to go to a pharmacy. This will only be available in pharmacies, and it will only be available - as they call it - behind the counter. So you're going to have the pharmacist for it, which means that you will only be able to get it when the pharmacy is open and there is a pharmacist on duty. So you're now assuming that you have a pharmacy that's open when you need it, that there's a pharmacist there, and that there's a pharmacist willing to sell it to you. Because there have been cases of pharmacists around the country - a small group, but still a significant number - who, again, have ethical problems thinking that this is a very early abortion and refusing to sell it at all.
MONTAGNE: And has the manufacturer said yet when it would start selling the drug as a nonprescription drug?
ROVNER: Yes, they very much hope to get it on shelves before the end of the year, possibly as early as November. They have to actually change the labeling before it can be made available without a prescription, and that's just going to take a little time to get it done and actually get it on the shelf.
MONTAGNE: NPR's Julie Rover, thanks very much.
ROVNER: You're very welcome.
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