The makers of the emergency contraceptive sold under the name "Plan B" want their product to be available on drugstore shelves alongside the cold remedies and toothpaste, and they are planning to petition the Food and Drug Administration today for the right to sell it without a prescription.
If the application is approved, the drug would be the first "morning after" contraceptive to be sold over the counter, and its distributor says a major advertising campaign to increase its use would likely follow.
Similar morning-after contraceptives are available without prescriptions in Europe, where they are increasingly popular. But there is some concern that the effort here could become entangled in the abortion debate -- although the makers of Plan B say their product prevents conception, rather than aborting an egg that has been fertilized.
"Studies have shown that there are 37 million contraceptive accidents here each year -- where a condom breaks or a woman forgets to take her pill and she has unprotected sex," said Sharon Camp, chief executive of Women's Capital Corp., which sponsored the drug before the FDA and now provides it nationally.
"If these women had an emergency contraceptive, then we could reduce unintended pregnancies by half and abortions by half," she said. "Our sales in the United States are relatively small, and there is a great unmet need."
Advocates of emergency contraception say it has already helped decrease the number of abortions in the United States in the past five years, but others point to different causes. Camp said about 3 million doses of Plan B have been sold since it was first approved by the FDA in 1999.
Plan B uses the hormone progestin to interfere with a woman's ovulation and the fertilization of her egg, a process similar to what happens when women take traditional birth control pills. The treatment is usually effective within 72 hours after intercourse, but Camp said its ability to prevent pregnancy diminishes by 50 percent over the first 12 hours. As a result, she said, it is important for women to be able to buy an emergency contraceptive quickly at a drugstore the next morning, rather than having to first go to a doctor to get a prescription.
Emergency contraception is available without a prescription in California, Washington and several other states, but it remains a "behind-the-counter" drug that must be requested from a pharmacist, who provides counseling in its use.
Persuaded of its potential public health benefits, other governments and advocacy groups have tried to make it more easily available. Earlier this year, the New York City Council required that pharmacies not stocking emergency contraception post a sign to that effect, so that women would not have to needlessly wait in line. Programs such as these would become unnecessary if the FDA approves the over-the-counter request.
Antiabortion groups have not had a uniform approach to emergency contraceptives, with some opposed to their sale and use and some silent on the subject.
Judie Brown, president of the American Life League in Virginia, said earlier this year of morning-after pills, "You can have all the wiggle room you want and all the language you want, but this is still abortion, and these pills should not be available for any reason." Efforts to reach several groups were unsuccessful this weekend. But Camp said many other groups opposed to abortion see Plan B as a contraceptive, and not as an abortion agent.
FDA officials have told the makers of Plan B that it will take about 10 months to review their application, and that the agency will schedule a public joint hearing before the agency's Reproductive Health and Nonprescription Drug Advisory committees.
The medical community has been using some form of morning-after pill since the 1970s, when it was discovered that an increased dose of common progestin-estrogen birth control pills could keep an egg from being fertilized after intercourse. The treatment was generally restricted to rape-crisis centers until the late 1990s, when two morning-after pills were approved by the FDA for use with a doctor's prescription. The other emergency contraceptive is called Preven, an estrogen and progestin combination sold by Gynetics.
Both versions of the morning-after pill are marketed by small companies that have little money for advertising. The distributor for Plan B, Women's Capital Corp., has a staff of three and relies on foundation support and venture capital money from investors, who often believe in the social value of the product as much as the likelihood of a future profit.
Camp said she hoped that a larger drug company -- with money for a major advertising campaign -- would purchase the rights to Plan B if it looked as if it was going to get over-the-counter approval.
"This could be a model for rescuing orphan technologies," she said. "If we can make this work OTC and hand it off to a major pharmaceutical company, then other important but unused treatments could follow."
Camp said that Plan B's cost would remain about $27 a dose if it received FDA approval for nonprescription use. But she said it is sometimes available for less in family planning and other public health facilities.