Last December, an FDA advisory panel voted overwhelmingly in favor of making emergency contraception easily available, ruling that a drug called Plan B (levonorgestrel) should be sold in pharmacies without a prescription. It was a huge victory for reproductive rights groups, who went home exhilarated by the prospect that Plan B would soon materialize on drug store shelves, as easy to buy as Tylenol or Trojans or Slim-Fast.
In early May, the acting director of the FDA's Center for Drug Evaluation and Research, Steven Galson, derailed that hope by nixing the application on the grounds that access to emergency contraception might harm the very youngest teens. Plan B's proponents had failed, he said, to supply data about the drug's impact on "the younger age group from 11 to 14, where we know there's a substantial amount of sexual activity." It was a puzzling assertion, accompanying what many suspected was a politically motivated decision: There is plenty we don't know about young teens, but one of the things we do know is that they have very little sex at all. And what we know about the sex they are having only reinforces the case for making emergency contraception more available. As a reason for sabotaging efforts to take Plan B over-the-counter, Galson could hardly have reached for a more ironic one—and reach he certainly did.
Emergency contraception, also known as the morning-after pill, is a highly effective form of hormonal birth control. Often wrongly confused with RU-486, EC does not induce abortion; instead, when taken after unprotected sex or condom failure, it prevents pregnancy from occurring. For years women turned to Web sites to learn how to mix their own off-label EC, which is really just a cocktail of regular birth-control pills. Plan B was born when a woman named Sharon Camp formed a small company to distribute a dedicated EC product. In 1999 Plan B was approved for prescription use, but Camp had higher ambitions. If women could buy Plan B without having to ask a doctor first, she and others believed that it could cut America's abortion rate in half.
It's a drug that works at its best when ready to hand. While EC can be taken up to 36 hours after intercourse, it's much more effective if taken right away, and its efficacy decreases with each passing hour. Most sex does not occur during doctors' working hours, so a quick prescription is hard to come by. Last year Camp's company was sold to Barr Laboratories, which agreed to spearhead an over-the-counter campaign. As a prescription product, Plan B was already deemed safe and effective, so Barr's task was to show that women could safely take it unsupervised. Buttonholing women in shopping malls, researchers found women had no trouble reading the label. In family-planning clinics, a group of patients was given Plan B in advance, to gauge whether easy access would promote unsafe sex, but this did not turn out to be the case.
The data were so conclusive that the over-the-counter switch was backed by major medical associations, including the American Academy of Pediatrics and the Society for Adolescent Medicine. The FDA advisory panel—which consisted of doctors, health experts, and social scientists—judged Barr's data to clinch the case. One panel member called it the "safest drug that we have seen brought before us." But the data didn't satisfy Galson. Denying any suggestion that he'd been swayed by objections from red-state congressmen and far-right organizations, he took Barr to task for what he termed a major omission: the failure to consider Plan B's effects on girls between 11 and 14, particularly their condom use. "One in five are sexually active, as opposed to older adolescents, where it has leveled off," Galson explained in an interview recently. "If girls in this age group were not sexually active, it would not be an issue."
It may be that Galson's concerns are genuine, rather than, say, political cover in an election year, but they have scant basis in fact. Earlier this month, the FDA's own sister agency, the Centers for Disease Control and Prevention, published its latest Youth Risk Behavior Surveillance report. According to the 2003 data, just 7 percent of today's adolescents have sexual intercourse before the age of 13. Among these, the vast majority are boys. For girls—the population Galson is talking about—the figure is much lower: The 2003 data show that only 4 percent of girls have sex before they are 13.
Although Galson could not say where he got his own data, it's likely he's echoing the well-known figure—cited by a number of research groups—that one in five teens has sex before his or her 15th birthday. In 1995, 19 percent of girls had sex at least once before they were 15, compared to 11 percent in 1988. Those figures are outdated, however: The National Campaign To Prevent Teen Pregnancy isolated the newer CDC data for ninth-graders and found that in this group (14-year-olds to 15-year-olds) sexual activity has declined, as it has in the under-13 group. The CDC figures also make clear that the sexual activity of an almost-15-year-old is very different from that of an 11-year-old or a 12-year old. "Sex for very young teenagers remains the unusual case," says Sarah Brown, president of the National Campaign. While it's hard to pinpoint what's happening among 13-year-olds and 14-year-olds specifically, she points out that for all young teens, sex is very sporadic: A year can go by between the first experience and a second. "Activity picks up more robustly at 15, 16, 17."
Moreover, well before Galson made his decision, an interesting study, provided to the FDA, showed just how small a clientele for Plan B there is among the youngest cohort. A North Carolina research group called Family Health International placed ads in public places, announcing a hot line that anyone could call to have an EC prescription phoned in to a pharmacy. Over two years, 121 calls came from women 40 or older; 845 from women 30 to 39; and 4,000 from women 20 to 29. There were 783 calls from 19-year-olds, 840 from 18-year-olds, 612 from 17-year-olds, 409 from 16-year-olds, and 167 from 15-year-olds. From there the call volume plummeted: Just 31 calls came from 14-year-olds and four from 13-year-olds. No 12-year-olds called in. One 11-year-old did. Combined, girls ages 11 to 14 made just 36 out of 8,000 EC requests, less than .5 percent of the total.
And let's consider those few: young, at-risk girls who are having sex despite efforts of right and left alike to dissuade them. Among this cohort, sex is least likely to be planned and least likely to be protected; stocking birth control "requires a level of planfulness that is not common at that age," as Kristen Moore, president of the research group Child Trends, puts it. For these girls, an after-the-fact form of contraception could be more crucial than for anybody.
It's also important to remember that the younger the girl, the more likely sex is to be coercive, usually forced on her by an older partner. According to the Alan Guttmacher Institute, seven out of 10 girls who have sex before the age of 13 do so involuntarily. These vulnerable teens are hardly in a position to make their partners wear a condom. Emergency contraception would give them a shot at staving off the consequences—consequences that hit young teenagers the hardest. It's often difficult for a young teen to get an abortion, thanks in part to parental notification and parental consent laws. Childbirth, too, is a terrible thing for this age group. Young teen mothers are least likely to get prenatal care, most likely to deliver low birth-weight babies, and totally unprepared to be parents.
Yet flimsy as it is, the young teen excuse is the one that Barr's company is going to have to deal with as it scrounges for the new information required to get the FDA to reconsider its "nonapprovable letter." One possibility Galson held out was for Barr to do a study assessing the effect of over-the-counter Plan B on the youngest girls. The trouble is that the federal government itself forbids researchers from talking about sex with this age group. CDC researchers, for example, must gather their data on young teens by asking older teens, retrospectively, about their first sexual encounter. Barr's researchers, when they first fanned out into those malls, were forbidden from interviewing unaccompanied teenagers, even older ones, which meant excluding what is arguably the most relevant portion of that age group. Even in family-planning clinics, Barr could not interview any lone teen under 14. In inviting further teen studies, Galson was asking the near-impossible.
It's no wonder that Carol Cox, a spokeswoman for Barr, says it will take too long to provide the data on young teens. Instead, the company will soon submit a plan to make Plan B over-the-counter for women 16 and older and available only by prescription to younger teenagers. This means, Cox acknowledges, that Plan B will almost certainly be stocked behind the register, not on the shelves. And that means any woman—of any age—will have to ask for it to get it, when not having to ask for it was the point to begin with.