No Rx Required

The Fight to Make Morning-After Pills Available Over the Counter

Even if the average American woman continuously uses birth control throughout her reproductive years, she will have two unintended pregnancies. In real life, our reversible methods of contraception are highly unreliable: People forget to take some of their birth control pills, while condoms tear and slip—or the supply of either unexpectedly runs out. Many women find present birth control so awkward and uncomfortable that continuous use is not even a reality. And so, half the 6.3 million pregnancies in America each year are accidents.

Yet it has been known for 30 years that there is a second chance to prevent pregnancy: If you haven't used birth control properly before sex, you can still use it immediately afterward. Since 1999, there have been two FDA-approved prescription drugs made specifically for this purpose. A bill expected to be introduced this week in the New York State Assembly would make these drugs available without a prescription.

Studies show that emergency contraceptives can prevent up to 90 percent of pregnancies if used within three days of unprotected sex. When used during the first 12 hours, they are nearly 100 percent effective, but their efficacy steadily declines after that. These drugs "could reduce the number of abortions by half, but women just don't know about them," says James Trussell, a faculty associate at Princeton University's Office of Population Research. "And even if women know about these drugs, then they need to get them very quickly. And not many people can go to the doctor, get a prescription, and have it filled in 12 hours."

The assembly bill would set up a system for dispensing emergency contraception directly through drug stores, bypassing the need to go to a doctor first. Interested pharmacists would enter into collaborative agreements with a physician. The state would then certify them to provide the pills along with appropriate patient screening and counseling in their use. A three-year-old system like this in Washington state has distributed morning-after pills to over 25,000 women. Several European countries, including Britain and France, have instituted similar programs in the past year.

"Women should have the fullest range of health care," says Amy Paulin, a Democrat from Westchester, the New York bill's main sponsor. "We want to reduce the high rate of unwanted pregnancies and abortions in New York. My bill gives women access to a less invasive procedure that helps them be in charge of their own bodies."

Several measures now before the New York legislature reflect a growing interest in emergency contraception. But religious objections have stalled their progress. The controversial Women's Health and Wellness Act would mandate health insurance coverage for a variety of health services, including emergency contraception. The bill passed the senate and assembly but is now held up because the senate approved an exemption for institutions owned by churches that object to birth control.

Another pending bill would mandate that hospital emergency rooms provide emergency contraceptives to women who have been raped. This bill has been stagnating in the senate for the past two years, reportedly due to the opposition of Majority Leader Joseph Bruno. The bill's chief sponsor, Upper West Side Democrat Eric Schneiderman, says opposition from the New York State Catholic Conference is "critical." The conference, which lobbies on behalf of the state's dioceses, wrote to legislators last year objecting to the inclusion of Catholic hospitals in the bill's requirement to "provide state-mandated contraception and abortifacient treatment to rape victims."

Kathleen Gallagher, the state Catholic Conference's associate director, explained, "We oppose the bill because the state would impose a moral mandate on religious facilities, damaging religious freedom. Catholic hospitals would give drugs to prevent eggs from being released, but if drugs prevent implantation [of a fertilized egg], then they will not provide them."

Gallagher went on, "We would very likely oppose the pharmacy bill because it would include anybody, including a 14-year-old. It's very dangerous for a minor to get such treatment without understanding how the drugs work or when to take them. Would she really understand the risks involved, the counseling that she received without her parents' advice?"

Parental consent is not even required for abortion in New York, and no state has such a provision for birth control. Yet disagreement over adding parental consent killed a bill similar to New York's that had passed both houses of the Virginia legislature this winter. Paulin took strong exception to including a parental consent provision: "On its face, this is a bad idea because it prevents teenagers' timely access. I had a good relationship with my parents when I was a teenager, and I still couldn't have talked to them about having unprotected sex."

Opposition to emergency contraceptives arises over a highly sensitive semantic point. Emergency contraceptives probably act like regular birth control pills do, but nobody is quite sure how these pills work. They are likely to delay or block ovulation, but not always. Should a woman's egg mature and become fertilized, oral contraceptives also cause a women's uterus to be unprepared for the egg's implantation and development. Fundamentalists generally define human life as beginning with fertilization and regard oral contraceptives as potential abortifacients. But the 40,000-member American College of Obstetricians and Gynecologists has long held that implantation—not fertilization—is the real beginning of pregnancy.

Trussell engaged in a bit of hyperbole: "Emergency contraceptives may work by inhibiting implantation as do regular oral contraceptives—and breast-feeding, too. So we'd have to ban all of that. Anyway, more than half of all fertilized eggs don't implant but go away. It's called having your period—we would have to bury tampons with honor."

Emergency contraception pills are too expensive, too unpleasant, and not effective enough to replace your usual form of contraception. (See below: "How Morning-After Pills Work.") The major side effects are nausea and vomiting, fatigue and headaches. They also do not prevent STDs. But these problems are not serious enough to cancel out the evident benefit of the drugs."People need counseling about how to use them, but only if they have major medical conditions," says Jini Tanenhaus, vice president for clinician training at New York Planned Parenthood. "And screening takes only a few minutes."

Planned Parenthood writes a multiple-use prescription for clients who request it. It also gives out "prophylactic" prescriptions to those who use condoms and other barrier methods as their regular means of birth control. Women can then have a supply at hand whenever the need arises.

Still, the argument that emergency contraception requires better medical supervision than a pharmacist can provide attracts support from across the political spectrum. One pro-choice staffer in the U.S. House of Representatives, who spoke off the record, said, "There is a legitimate debate among people who care about women's health. Would people stop going to gynecologists if they could get the drugs over the counter? An opportunity to educate and examine women would be lost, some people think." Such sentiments are not far from those advanced by the antiabortion group Pharmacists for Life International.

Yet many druggists would gladly accept the challenge of informing their customers, says Craig Burridge, executive director of the Pharmacists Society of the State of New York. He points out that there is a national trend to improve pharmacists' training and involve them in patient counseling on a wide range of medical issues. The society is now cooperating in a program for training pharmacists on the use of emergency contraception.

In the end, the Food and Drug Administration may decide to remove all counseling and prescription restrictions across the country. Last Valentine's Day, a coalition of 76 organizations petitioned the agency to allow morning-after pills to be sold over the counter in pharmacies and other stores. That same day, the OB-GYN professional society issued its own statement supporting this arrangement. "Because emergency contraception poses no known health risks, has minor side effects, and can be taken in two simple, identical doses without medical supervision," says Bonnie Scott Jones, staff attorney at the Center for Reproductive Law and Policy, "it meets all the criteria necessary for over-the-counter status."

A 1996 petition by a similar coalition led the FDA to declare emergency contraception safe and effective. It invited companies to submit marketing applications for specific products. One of the two start-up companies that responded, the Women's Capital Corporation, is now pursuing a traditional testing program to convert its brand, Plan B, to over-the-counter use. Sharon Camp, the company's president, met with FDA officials in February and termed the meeting "positive and constructive." Her application for making Plan B available over the counter is about a year away.

Emergency contraception will be the first new reproductive rights issue confronting the Bush administration. Bush and Tommy Thompson, his new secretary of Health and Human Services, have already shown themselves hostile to abortion. Their handling of this issue will be a sign of how far that opposition extends. "Emergency contraception has been on the brink of going over the counter," says Rosemary Dempsey, director of CRLP's Washington office. "The FDA was clearly leaning in that direction. But Thompson could reverse this. We don't know what's going to happen."


How Morning-After Pills Work Women can conceive only during the 24-hour ovulation phase in the middle of the menstrual cycle, when an egg is released. At that point, the chances of pregnancy after unprotected sex reach 33 percent. Sperm can survive in a woman's body for up to five days, so that the window for pregnancy is considerably longer than it might appear. But even after sperm fertilizes egg, pregnancy is not assured. A critical step called implantation takes place five to seven days later. That's when the primitive embryo—just a tiny ball of cells—has to attach itself to the wall of the uterus. Much of the time, implantation fails and pregnancy does not occur. Emergency contraceptives provide a large hit of female hormones that probably affects all these steps. They are known to delay ovulation when taken before that date. They also have considerable effect when sex occurs on the day of ovulation. That is why many researchers believe the drugs also interfere with implantation. But emergency contraception does not interfere with the development of an implanted embryo. Until 1998, anyone wishing to use the morning-after pill had to take four or five tablets in two doses 12 hours apart and within 72 hours of intercourse. There are now two drugs on the U.S. market that are much more convenient to use. Preven is a combination of estrogen and progestin; Plan B contains progestin only. A large study by the World Health Organization compared the two drugs and found that Preven prevented 57 percent of expected pregnancies while Plan B reduced the number by 85 percent. Nausea, the principle side effect of emergency contraceptive pills (ECPs), occurred in half the women receiving Preven and in a quarter of those taking Plan B. Vomiting was infrequent with Plan B. Either drug costs in the $20 to $30 range. Preven can be found in about half of all drugstores, according to its manufacturer, while Plan B is much rarer. Few doctors routinely discuss or prescribe these drugs. Even fewer will offer to write prescriptions in advance so that their patients can have a supply on hand. Planned Parenthood clinics are a common source of advice and prescriptions, and the Princeton University Office of Population Research sponsors a hot line (1-888-NOT-2-LATE) and aWeb site that provides information on emergency contraceptives and their availability.

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