Why is the U.S. Food and Drug Administration (FDA) trying to regulate the sexual morality of American women? Barr Pharmaceuticals wants to be able to offer its morning-after contraceptive levonorgestrel, marketed as Plan B, over the counter rather than by prescription. Plan B consists of two high-dose contraceptive pills that either interfere with ovulation or fertilization, or prevent implantation of a fertilized egg. It has no effect once an egg is firmly implanted in the uterine wall.
On average, if 100 women have unprotected intercourse once during the second or third week of their cycle, eight will become pregnant. Taken within 72 hours after unprotected sex, Plan B reduces the average risk of pregnancy among users from about 8 percent to about 1 percent—an 89 percent reduction. The product, marketed only by prescription in the U.S. since July 1999, could be sold for around $30 per dose over the counter.
On December 16, 2003, a joint panel of the FDA's Reproductive Health Drugs Advisory Committee and Non-prescription Drugs Advisory Committee voted 23 to 4 to recommend that the FDA approve the application to make Plan B available over the counter. At the hearing proponents and opponents weighed in. One particularly interesting comment was made by Jennifer Taylor of the anti-abortion Human Life International. She declared that women who use emergency contraception show an "inability to control themselves in sexual situations."
One of the four panel members voting "no" was controversial pro-life Kentucky obstetrician/gynecologist Dr. W. David Hager. Dr. Hager refuses to prescribe contraceptives to unmarried women and recommends that women with premenstrual syndrome read Scripture and pray. Hager is also the author of As Jesus Cared for Women: Restoring Women Then and Now.
In February 2004, 49 Republican members of Congress signed a letter to President Bush urging that Plan B's prescription-only status be maintained because wider use could result in more sexual promiscuity and venereal disease.
On May 6, 2004, the FDA rejected the advice of its scientific advisory boards and refused to approve the over-the-counter sale of Plan B. The FDA claimed Plan B had not been tested in enough adolescent females to prove that it's safe for them to use. However, proponents saw the FDA's assertions as a political move to appease the Bush administration's pro-life allies.
After all, agency staffers noted that this was the first time this issue had ever been raised. "The agency has not [previously] distinguished the safety and efficacy of Plan B and other forms of hormonal contraception among different ages of women of childbearing potential, and I am not aware of any compelling scientific reason for such a distinction in this case," wrote John Jenkins, director of the FDA's Office of New Drugs, in an internal memo leaked to The Washington Post.
So Barr Pharmaceuticals is being forced to jump through further hoops to try to get Plan B approved for sale without a prescription. Now the company has proposed an arrangement in which Plan B would be available to women over age 16 without a prescription behind the counter. That is, a woman would have to ask a pharmacist to hand her a package of the pills before she could buy them. (Women under 16 would require a prescription.) The FDA is expected to rule on this new proposal from Barr later this month.
A new study published last week in the Journal of the American Medical Association found that women who had been supplied with Plan B beforehand were twice as likely to use it as those who had access to it only through clinics. Also, women who had Plan B at home were no more likely to engage in unprotected sex than those whose access was restricted. Interestingly, the study found "women in the pharmacy access and advance provision groups did not experience a significant reduction in pregnancy rate." This undercuts the hope of Plan B proponents that wider use of the pills could cut in half the nation's 3 million unintended pregnancies each year and in turn prevent hundreds of thousands of abortions.
Never mind if both the hopes and the fears of how women will actually use Plan B are exaggerated—those who want easy access to it should be able to have it. And even if the availability of Plan B did encourage women to have more unprotected sex, why is that any business of FDA regulators? Sure, having sex with lots of partners without using condoms increases the chances of being infected with venereal diseases and becoming pregnant. But that's the woman's and her partners' lookout, not that of the bluenoses who are apparently running the FDA.
The FDA is supposed to approve drugs that are safe and effective for their indication—in this case preventing unintended pregnancies after unprotected sex. Plan B clearly does this. If the FDA wants to prevent or cure sexually transmitted diseases, then it should worry about approving vaccines and drugs for that purpose. In the meantime, as far as the available scientific evidence goes, there is no reason why Plan B shouldn't be on drugstore shelves right next to the Trojan and Durex displays.