If a “morning-after” birth control pill becomes available without a prescription, should teenagers be able to buy it?
That question has stalled federal approval of a plan to make a prescription-only contraceptive called Plan B available over the counter, as the measure has gotten snagged on the political and moral battle over teenage sexual behavior.
Supporters of the switch say it will help prevent teen pregnancies, while opponents say it will encourage teens to engage in more sexual activity and in unprotected sex.
“Eighty percent of all teen pregnancies are unintended. This statistic necessitates action based on the reality of teens’ lives rather than our collective wish that teens postpone sexual activity,” Dr. Gretchen Stuart of Texas told an advisory panel of the U.S. Food and Drug Administration (FDA), which is considering the plan.
But another obstetrician, Dr. John Bruchalski of the Catholic Medical Association, warned, “Without medical advice from a health professional, the use of Plan B by teens will be disastrous.”
A dose of Plan B consists of two tablets of a hormone, levonorgestrel, which can prevent a pregnancy from starting (unlike so-called “abortion pills,” such as RU-486). Plan B has been sold via prescription since 2000 by Women’s Capital Corp., which asked for the change along with Barr Laboratories, which has purchased the rights to the drug.
Two FDA advisory committees recommended in December, by a 23-4 vote, that the FDA approve the change to nonprescription status. The FDA was to have acted by now, but in February, 49 Republican members of Congress wrote a letter urging the agency to delay its decision. The FDA extended its deadline to May 21 and asked Barr for more information. The FDA was concerned about “the age issue,” a Barr executive told The Washington Post.
Two members of the advisory panels and an editor at the New England Journal of Medicine responded with an editorial in the April 8 issue of the Journal saying that the postponement “suggests that the FDA’s decision-making process is being influenced by political considerations.”
“The delay results from the concern of some groups, without any supporting data, that the availability of the drug may have a corrupting influence on sexual behavior,” the editorial says. It says studies show that “having emergency contraception on hand does not result in higher rates of unprotected intercourse” among sexually active adolescents.
But Carole Denner, a state legislative liaison in Virginia for Concerned Women for America, a faith-based public policy group, says making Plan B so easily available “can convey to young adults the idea that one does not have to think through one’s actions.”
One compromise being floated is to keep Plan B behind the counter, so that buyers would have to request it from a pharmacist or cashier, who would ask for proof of age. “If I was 16 or under, I would be told, ‘You can’t get this product, you need a prescription,’ ” says Kirsten Moore, president of the Reproductive Health Technologies Project, which supports making the drug available to everyone.
Advocates for the change say most girls would be unlikely to ask a pharmacist or drug store employee for a morning-after pill that’s kept behind a counter. And for the few who would be willing and able to quickly squeeze in a doctor’s appointment for a prescription, they say, the wait would make pregnancy more likely.
Barr says Plan B reduces the chance of pregnancy by 89 percent after a single act of unprotected sex. While it can be effective for up to 72 hours after intercourse, it is significantly more effective within 24 hours.
“We understand the concern that the general public has about young women’s access to emergency contraception,” Moore says. But “women between 14 and 16 who might need emergency contraception … would be better served by getting their hands on it quickly.”
Opponents of the change say it is safer for females of any age to consult with physicians before starting to take a contraceptive, and that girls especially need that help. They say doctors can make sure a girl understands the uses and limits of the drug and the benefits of using other contraceptives (such as condoms) to prevent sexually transmitted diseases, and they can test the girls for those diseases.
Denner of Concerned Women says the group opposes over-the-counter sales of Plan B to anyone, regardless of age, because there hasn’t been sufficient research into the physical effects of long-term, repeated use. “We don’t know the effect on the bodies of the women,” she says.
Barr spokeswoman Carol A. Cox said the FDA asked Barr to “look at some information differently” regarding two types of data: the use of emergency contraception and customers’ comprehension of the information on the drug’s label. Moore says the FDA asked Barr to “re-cut the data” to focus on smaller age group segments, such as under 15, and 16 to 18.
There is relatively little research about emergency contraceptive use by young teens, because so few of them use it.
The National Campaign to Prevent Teen Pregnancy supports the change. Teens “are often skittish about seeking care for problems relating to their sexual lives,” campaign Director Sarah Brown wrote to the FDA in December. “By making EC [emergency contraception] more easily available, the chances of teens using this method early … increase, thereby avoiding unintended pregnancy.”
The United States has one of the highest teen pregnancy rates in the industrialized world, although the rate dropped from about 116 per 1,000 girls (ages 15 to 19) in 1990 to 84 per 1,000 in 2000, according to the U.S. Department of Health and Human Services (HHS) and the Alan Guttmacher Institute. Each year, close to 900,000 U.S. teens become pregnant, according to HHS.