JEFFREY BROWN: Last year, the Food and Drug Administration rejected a recommendation by its own advisory board that the so- called "Plan B" drug be made available over the counter. The FDA action stirred wide debate and criticism, and this week, the Government Accountability Office issued a report raising many questions about what it called the FDA's "unusual" decision- making.
Here to take us through the story is our health correspondent, Susan Dentzer. The health unit is a partnership with the Robert Wood Johnson Foundation.
SUSAN DENTZER: Thanks, Jeff.
JEFFREY BROWN: First remind us, what is Plan B, and why is it so controversial?
SUSAN DENTZER: Plan B is an emergency contraceptive. It's the so-called "morning after pill." It's taken after sexual intercourse. It's essentially high-dose birth control pills taken after intercourse to prevent ovulation or interfere with fertilization of an egg by a sperm.
It's been controversial among social conservatives for several reasons: For one thing, there seems to be some misinformation that it is really an anti-abortion - or, rather, an abortion-inducing pill, which it is not; it doesn't cause an abortion. It actually interferes with fertilization or with ovulation. It's a contraceptive, some confusion about that.
The other source of concern among social conservatives has been in making it broadly available, especially among younger teenagers, if you were to make it available over the counter, would lead to greater sexual promiscuity among teenagers.
JEFFREY BROWN: All right. So last year, the FDA rejected its sale over the counter. What was the reason for it?
SUSAN DENTZER: What the FDA wrote in the letter it sent Barr Laboratories, the owner of the rights to the drug, was that it was concerned about the fact that there was not sufficient scientific evidence about how younger teenagers, people below the age of 16, girls below the age of 16 would respond, how their behavior would change if the drug were to be made available over the counter, specifically, that we lacked evidence about the cognitive development, the maturity of younger teenagers.
And even though there had been information submitted about the effect in older teenagers, the FDA said we could not extrapolate from that the behavior of younger teenagers and therefore it could not be approved.
However, the FDA did offer Barr Labs a way out; it said that Barr Labs could come back, apply to make the drug available over the counter for women 16 and older, on a prescription basis for women younger than 16, and that the FDA would seriously consider that, and that, in effect, is what Barr then did.
JEFFREY BROWN: Now, the GAO looks at all of this and files a report this week that finds unusual, that's their word "unusual" decision making. Tell us what that means.
SUSAN DENTZER: Yes. And it said it was unusual in several respects. First of all, GAO said upper level FDA officials told lower level FDA officials that they, the upper level officials, would make the decision, not the lower level officials who customarily make these decisions.
Secondly, there's dispute about this but there's some suggestion that the upper level officials made the decision before all the scientific evidence was really in. And then the final thing that the GAO pointed to was this whole business about the cognitive development of younger teenagers. It said never before had FDA taken up a decision where it said we have to look at older adolescents and younger adolescents; we can't extrapolate one set of behavior from another, said this had never happened before, and this was highly, highly unusual.
JEFFREY BROWN: Now, the report, if I am right, did not go into why the FDA did this, but critics cried politics or they saw politics in it, correct?
SUSAN DENTZER: Yes, indeed. And the big elephant in the room, in effect, was why did the FDA do this? Democrats who asked the GAO to do this report in the first place, even many moderate Republicans are now saying in effect the Bush administration here, the FDA caved to the concerns of social conservatives, that and even though the GAO did not address that question, that appears to be a widely held belief.
The second thing the GAO did not address is what's happened since and we do know, as I said a moment ago, that Barr Labs came back, said to the FDA, okay, we would like to make it available on a prescription basis for kids under the age of 16, over the counter for older women.
And then what happened is just this past summer, the former FDA commissioner, Lester Crawford, before rather mysteriously resigning said in effect we have to do some more -- we're not -- having said that we think we can do this, we are not certain that we can do this and we must go through a very extensively rule-making process to determine whether it's even possible to have this kind of split availability of the drug, in effect, as some have charged kicking the can down the road, yet longer.
JEFFREY BROWN: So a kind of indefinite hold. But what happens next?
SUSAN DENTZER: Well, that's the big question. There is a bipartisan bill in Congress which bears the sardonic title of Plan B for Plan B Act which would say that in effect, the FDA would have 30 days to make a decision about whether to make the drug available over the counter; if not, it will be considered to be approved for over the counter use. Some Democrats are asking now for hearings to be held to look further at this. And we'll see just have to see what happens. In the meantime, the interesting thing is that prescriptions of Plan B have doubled.
JEFFREY BROWN: That's what I was going to ask you, are people using it or not?
SUSAN DENTZER: Absolutely. Prescriptions doubled; sales are rising; and now about $25 million worth a year and actually, seven states have acted to make the drug available on a so-called "behind the counter" basis. You don't need a prescription. You do have to go to the pharmacist and ask for the drug.
But seven states including a large one, California, have already made this broadly available. And so far the proponents of making this drug broadly available says there's no evidence that it's leading to any behavioral changes in anybody, including younger adolescents.
JEFFREY BROWN: All right, Susan. Thanks a lot.
SUSAN DENTZER: Thanks, Jeff.