While regulators ponder whether to make emergency contraceptive pills available over the counter, critics ask: Should drugs that prevent pregnancy really be as easy to get as aspirin?

By Leslie Laurence

When the condom broke while Maureen Perez, 28, and her husband, Gilbert, 41, were making love one night, the couple was frantic. They weren't ready for baby number four. Maureen had already postponed college to raise their sons, ages seven, four and two, and the family barely fit in their two-bedroom house in Redland, Calif. Maureen told her husband that, if she became pregnant, she wanted an abortion.

Gilbert thought there might be another option. He had read about a pill that could prevent pregnancy after unprotected sex. On the Internet, Maureen found www.not-2-late.com, a Web site run by the Association of Reproductive Health Professionals, a group that educates medical providers in the United States. The site lists local physicians willing to prescribe emergency contraceptives (EC), which are essentially higher doses of standard birth control pills. When taken within 72 hours of unprotected sex, the pills reduce the risk of pregnancy by 75% to 88% (depending on the type of pills taken). The next day, Maureen picked up two tiny pills at a nearby doctor's office. She took one right away and the other 12 hours later. She didn't get pregnant, and the young mother is convinced that EC saved her worry, stress and possibly the unpleasant choice between an unwanted pregnancy and an abortion. "A woman should be able to just buy it at the drug store without a prescription," she insists. In Norway, Portugal, the United Kingdom and France women already can. In fact, France permits school nurses to dispense the pills, and in January 2002, it began allowing women under 18 to get EC for free at any pharmacy -- without parental consent.

Right now, that's not the case in this country. For decades, oral contraceptives were quietly dispensed as "morning-after" protection by reproductive health clinics and sympathetic private doctors. In 1998, the off-label therapy was formally packaged as emergency contraception. Currently, there are two prescription products on the market: Plan B, a two-pill regimen that contains the synthetic progestin levonorgestrel, and Preven, four pills that combine levonorgestrel and ethinyl estradiol.

However, access remains problematic. For one thing, few women are aware of the EC option. Marketing hurdles -- such as an unrealistically short initial shelf-life imposed by the FDA -- made EC unprofitable to distribute and advertise. In a poll released in November 2000 by the Kaiser Family Foundation, one-fourth of the women aged 18 to 44 surveyed said they had never heard of EC, and nearly two-thirds said they didn't realize it was available in the United States. And, in the absence of patient demand, less than a third of gynecologists contacted in a separate KFF survey of women's health care providers that same month said they wrote prescriptions for EC on a regular basis, although virtually all said they considered the drugs safe and effective.

Even patients who seek out EC often find it difficult to obtain. On weekends, says Bonnie Scott Jones, staff attorney for the Center for Reproductive Law and Policy, a Washington, D.C., not-for-profit advocacy group, "there are not many physicians available (to write a prescription) in many parts of the country." Kirsten Moore, director of the Reproductive Health Technologies Project, agrees. "Under the best of circumstances, Monday through Friday from nine to five, only three in five calls to health care providers result in women getting a prescription," she observes. The reasons patients come up empty-handed, says Moore, range from being unable to reach their provider to the provider refusing to write a prescription for a non-patient, or gaps in communication between the front desk and the doctor. To increase awareness about the availability of EC and encourage women to secure a prescription in advance, RHTP and a coalition of medical and women's policy groups will roll out a "back up your birth control" public information campaign this spring.

But some women's health advocates and mainstream medical groups, including the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists, have issued statements saying it's time to take EC over the counter. In a February 2001 citizen petition to the FDA filed on behalf of more than 60 organizations, CRLP argued that EC merits nonprescription status. "It's clear to us, looking at the legal standards, that EC fits," notes Elizabeth Cavendish, legal director of the National Abortion and Reproductive Rights Action League. "A woman can diagnose herself -- she knows if she's had unprotected sex -- it's not a high-risk item and the procedures for using it are not hard to understand."

Most antiabortion groups have not taken a public stand on the matter, perhaps because they don't consider the drugs abortifacients. EC poses no threat to an already existing pregnancy. Unlike mifepristone, the abortion pill known as RU-486, which causes a fetus to be expelled from the uterus, EC prevents pregnancy primarily by halting ovulation, eliminating the risk that long-lived sperm will fertilize an egg produced after intercourse. Some researchers suggest that, depending on where a woman is in her menstrual cycle, the drugs may also prevent pregnancy by inhibiting fertilization or implantation, which is the medical definition of a pregnancy.

The American Life League -- an antiabortion group that opposes all forms of artificial contraception -- has vigorously opposed EC. "We are stunned at the fact that those who promote these pills do not admit upfront the potential is there to kill," says ALL President Judie Brown. "A human being occurs at fertilization, not at some time convenient for the proponents of morning-after pills." Her group has submitted written comments to the FDA opposing the switch to nonprescription status. Brown also argues that easy availability will allow the drugs to be used far too often. "Will you ingest these pills every time you think you might be pregnant? If you're talking about a 15-year-old, how many times could that be in her lifetime? No developing adolescent should be able to take something that powerful over the counter."

James Trussell, Ph.D., professor of economics and public affairs at Princeton University's Office of Population Research, disagrees. "There is absolutely no reason this drug should be prescription only. I consider it safer than aspirin. Aspirin can kill people. Emergency contraceptive pills can't." However, he says, patients need to be told that EC "is not a (substitute for) regular contraceptives." That's because it doesn't offer as much pregnancy protection as methods used regularly and correctly, such as birth control pills, which are more than 99% effective, or condoms, which are 97% effective. For this reason, profligate use of EC may not be a hazard. A study conducted in Scotland and published in the New England Journal of Medicine in 1998 found that women who obtained EC in advance -- to keep in their medicine cabinets or night stands or to carry with them -- did not abandon their regular methods of contraception.

In fact, providing EC over the counter might even produce a public health benefit, argues Trussell. Of the 2.7 million unintended pregnancies each year in the United States, half are estimated to be the result of contraceptive failure, and half end in abortion. Trussell says that wider use of emergency contraception could reduce by about 50% each the number of unintended pregnancies and abortions in the United States.

So far, the FDA has kept mum on whether it intends to let EC go over the counter. In September, the agency responded to the citizens' petition saying that it needed more time to review the data. There still was no word in late December. In the meantime, Women's Capital Corporation, which sells Plan B, is readying its application for a switch to nonprescription status and expects to submit it to the FDA in mid-2002. Gynetics, which manufactures Preven, is working on a two-pill progestin-only version, which, like Plan B, is expected to have fewer side effects, such as nausea and vomiting. However, the company has not applied for over-the-counter status.

Getting stores to stock EC among their other mass-market offerings may be tricky, explains Gynetics chairman Roderick Mackenzie. "We have to compete for shelf space with Clairol and pregnancy tests. Stores will insist there be a very expensive consumer advertising campaign." To convince drug stores such as Walgreens and Duane Reade to carry the pills would cost $40 million to $50 million a year for the first three years, says Mackenzie, and it would require a partner with "very deep pockets." Sharon Camp, Ph.D., president and CEO of Women's Capital Corp., agrees. "Emergency contraception could be a $150-million-a-year drug category -- if we could get it over the counter and get pharmacies to stock it and market it directly to women. At present, it's a very costly marketing proposition."

For more information on emergency contraception, or to find a provider in your area, call 1-888-NOT 2 LATE or visit www.not-2-late.com.

*Part 2 of this report will examine legislation in several states that allow pharmacists to prescribe emergency contraception.

Leslie Laurence is a National Magazine Award-winning journalist specializing in women's health and health policy. Her work has appeared in Glamour, Town & Country, New York, Redbook and many other magazines.

This report is the 11th in kaisernetwork.org's series on emerging and underreported issues in HIV and Reproductive Health, which is available online.