Package of the emergency contraception drug Preven

(WOMENSENEWS)–Citing a public health epidemic of unintended pregnancies, medical leaders and women’s advocacy groups are urging the U.S. Food and Drug Administration to make emergency contraceptive pills available without a prescription.

Experts estimate that more than half of the three million unintended pregnancies that occur each year could be prevented with emergency contraceptives. In addition, experts say pills could reduce the number of abortions by 800,000 if they were widely used.

“It really is a no-brainer,” said Kirsten Moore, director of the Reproductive Health Technologies Project, a nonprofit advocacy group based in Washington, D.C.

Moore said emergency contraceptive pills, also known as the “morning after” pills, should be readily available because they meet FDA safety and other criteria for over-the-counter sales.

“Our contention is that emergency contraceptives are as safe–if not safer–than something like Tylenol,” she said.

AMA Supports the Change

The American Medical Association apparently agrees. The influential body supported the emergency contraception campaign last week when its House of Delegates voted, without debate, to recommend over-the-counter sales.

The organization’s Council on Medical Service said that because of the time factor many women would not be able to prevent unintended pregnancies if they had to visit a doctor and then fill prescriptions for emergency contraceptives. But over-the-counter sales would make it possible for women to do so.

And noted expert on emergency contraceptive, James Trussell, an economics professor in the Population Research Center at Princeton University, says: “Making emergency contraceptives more widely available in the United States is one of the most important steps that can be taken to reduce the incidence of unintended pregnancy and the consequent need for abortion.”

Two Brand Names Now Available by Prescription

Two emergency contraceptives, Plan B and Preven, have been available with a prescription for the past two years. However, they are not widely prescribed because women don’t know about them and doctors don’t promote them.

To be sold without a prescription, a drug must be free of life-threatening side effects and have easy-to-follow directions, said Laura Bradbard, a spokeswoman for the Food and Drug Administration.

In addition, the consumer must be able to self-diagnose the condition for which the drug is to be used, she said.

Reproductive Health Technologies’ Moore said that’s no problem: Women usually know if they have had unprotected sex within the past 72 hours and are at risk of pregnancy.

So far, little opposition to over-the-counter sales has emerged and Moore said it could remain that way.

Right-to-Life Group Uncertain

The National Right to Life Committee, the largest anti-abortion group, seems ambivalent because of uncertainty about exactly how emergency contraceptives work.

Some studies show pills work by delaying or preventing ovulation. If that’s the case, the anti-choice group would appear to have no objection because its statement on emergency contraception says it “takes no position on the prevention of fertilization.”

Other studies suggest emergency contraceptives may interfere with essential stages in fertilization or implantation of a fertilized egg in the uterus. In that case, the National Right to Life Committee may oppose the pills because its position statement says: “Once fertilization has occurred, a new human life has begun and NRLC is opposed to destroying that new human life.”

In practical terms, however, anti-choice groups may temper their opposition to emergency contraception because they prefer to focus their resources on opposing surgical abortions and medical abortions which use drugs such as mifepristone, the abortion pill also known as RU-486.

Mifepristone is part of a two-drug medical regimen that allows women to choose early abortions without a surgical procedure. Mifepristone also shows great promise as a treatment for shrinking uterine fibroids.

The crucial distinction here might be that if emergency contraceptives prevent pregnancy, the anti-choice group has no objection. Mifepristone for abortion, on the other hand, ends a pregnancy. In any event, a spokeswoman said the group “doesn’t deal with contraception.”

Three Types of Contraception Available

Three forms of emergency contraception–emergency contraceptive pills, emergency use of progestin-only mini-pills and emergency insertion of a copper intrauterine device–are available, according to the Kaiser Family Foundation, a non-profit research organization in Menlo Park, Calif. Emergency contraceptives are the most commonly used, the foundation reported.

Though they have been around since the 1970s, they have not been widely publicized or used. In recent years, however, several groups have taken steps to increase their availability and use.

In 1996, the American College of Obstetricians and Gynecologists published what is known as a “practice pattern” on emergency contraception as a means of encouraging members to prescribe it. In 1997, the FDA took the unusual step of encouraging manufacturers to make this additional contraceptive option available.

Emergency contraception is intended only for emergencies, such as when a woman has sex without using birth control and does not want to become pregnant; when a condom breaks or a diaphragm slips during sex; when a woman misses two or more birth control pills or is two or more days late starting her period; when a woman misses a birth control injection or is raped.

Emergency contraceptives are ordinary birth control pills in high doses. Treatment requires taking about two dozen pills. The first dose must be taken no more than 72 hours after unprotected sex. The second dose is taken 12 hours after the first dose.

Emergency contraceptives are not effective if a woman is already pregnant. They have no known serious adverse side effects, according to the Kaiser foundation, although some women experience nausea, vomiting, breast tenderness and other temporary side effects.

Almost all women can safely consider using emergency contraceptives, including some who would be advised not to take birth control pills on an ongoing basis, says the foundation.

Manufacturers May Be Unable to Underwrite Costs

Moore of Reproductive Health Technologies said she hopes that a commercial manufacturer will petition the FDA to change emergency contraceptives into over-the-counter products. Commercial petition is the standard process.

Two companies manufacture the pills, said Moore: Gynetics, based in Belle Mead, N.J., and Women’s Capital Corp., based in Welcome, Md. But both are small, new companies and it’s expensive to conduct the studies proving safety and efficacy so the FDA will approve a drug as an over-the-counter medication.

Rod Mackenzie, president of Gynetics, said his company is interested in turning the drug into an over-the-counter product, but does not have the resources to do that right now.

If neither company makes a move within the next few months, Moore said, several advocacy groups are poised to file a citizens’ petition, which would encourage the FDA to make the switch in the absence of a manufacturer’s request.

The American College of Obstetricians and Gynecologists and Physicians for Reproductive Health and Choice currently are deciding whether to support the over-the-counter status and formulating policy statements, she added.

Melinda Voss has a master’s degree in public health. A former reporter for the Des Moines Register, she now freelances and teaches journalism at the University of Minnesota.