Women’s Health Advocates Call on FDA To Act Swiftly
To Put Proven Birth Control Back-Up on the Drug Store Shelves

Events Planned in Dozens of Cities To Raise Awareness,
Improve Access to Emergency Contraception

Washington, DC - On Monday, March 22, 2004, a coalition of more than 100 women’s health and medical organizations will urge the U.S. Food and Drug Administration (FDA) to immediately make the Plan B® emergency contraceptive pill available to American women without a prescription. Last month, the FDA postponed a decision on making the drug an over-the-counter product, despite widespread support from the nation’s leading medical authorities and an overwhelming vote by the agency’s own expert advisory panel. Events are planned in dozens of cities on the third annual Back Up Your Birth Control day of action, a nationwide effort to help prevent unintended pregnancy by making sure women know about emergency contraception – and can get it in time.

“Scientists, doctors, and public health experts all agree that Plan B® is safe and effective – and belongs on the drug store shelves,” said Kirsten Moore, President of the Reproductive Health Technologies Project. “The FDA should act now to give more women a second chance to prevent unintended pregnancy and reduce the need for abortion. The longer the FDA waits, the longer women will be forced to play ‘beat the clock’ if their contraception fails or they had sex when they didn’t expect or want to.”

Plan B® is one of two dedicated emergency contraceptive products – often referred to as “morning after pills” – now sold in the United States with a prescription. The FDA approved both pills in the late 1990s, finding that they are safe and effective for women of all ages. When Plan B® is taken within 72 hours of unprotected sex or contraceptive failure, it reduces the risk of pregnancy by 89 percent – and research shows the sooner it’s taken, the better it works. Plan B® contains a low dose of the hormone progestin and prevents pregnancy the same way the birth control pill does. (It doesn’t work if a woman is already pregnant, and shouldn’t be confused with the medical abortion drug.)

On December 16, 2003, an FDA advisory panel of leading experts in the fields of reproductive health and non-prescription drugs came to the unanimous conclusion that Plan B® is safe for use without a prescription and voted 23-4 to recommend that the drug go over the counter. The panel based its findings on extensive scientific evidence, including data from many thousands of adult women and teenagers who have used progestin-only emergency contraception. A week before its February 20th deadline to decide about over-the-counter Plan B®, however, the FDA extended its review process by another 90 days. News reports about the delay – coupled with statements by emergency contraception opponents in Congress – indicate that political pressure was being brought to bear on the agency. The recent appointment of FDA Commissioner Mark McClellan to head the Centers for Medicare and Medicaid Services raises new questions about the fate of over-the-counter Plan B®.

More than 70 medical and public health groups – including the American Academy of Pediatrics, American Association of Family Physicians, American College of Obstetricians and Gynecologists and the American Medical Association – submitted written or oral testimony in support of making Plan B® available over the counter. This move, they argue, will enable more women to get back-up birth control in time – especially on nights and weekends, when need is greatest and doctor’s offices are closed. Studies show that requiring a prescription prevents some women from getting emergency contraception within its short window of effectiveness.

Research indicates that removing barriers to emergency contraception (such as the need to fill a prescription) leads more women to use back-up birth control when they need it. For example, adult women and teenagers who have gotten emergency contraception in advance are more likely to use it when they face a crisis. Having emergency contraception on hand does not increase the chances these women and teens will have unprotected sex or stop using their regular contraceptive method, including condoms. Use of emergency contraception is also not associated with an increased risk of sexually transmitted diseases.

In recent years, women’s health advocates have launched several initiatives to improve timely access to emergency contraception – from encouraging women to get prescriptions in advance to enabling women to obtain emergency contraception directly from an authorized pharmacist. Maine will become the sixth state to enact a pharmacy-access program on March 22, when Governor John Baldacci signs it into law as part of Back Up Your Birth Control day activities. Similar programs are already in place in Alaska, California, Hawaii, New Mexico, and Washington.

Experts estimate that emergency contraception could prevent as many as half of the 3 million unintended pregnancies that occur each year in the U.S., including as many as 700,000 pregnancies that now result in abortion. In 2000, this back-up birth control method is believed to have prevented as many as 50,000 abortions, even though only 2% of women had reported ever using emergency contraception. As of 2003, only 6% of American women said they had used back-up birth control at some point in their lives.

Progestin-based emergency contraceptive products containing the same low-dose hormone as Plan B®‚ are already available without a prescription in more than 30 countries, including France and the United Kingdom.

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