EXPERT FDA PANEL STRONGLY RECOMMENDS BIRTH CONTROL
“BACK UP” BE AVAILABLE WITHOUT PRESCRIPTION

Leading Medical and Health Groups Support Pharmaceutical
Company’s Request To Take Plan B‚ “Over the Counter”

Washington, DC - Today, a panel of experts voted overwhelmingly to recommend that the U.S. Food and Drug Administration (FDA) make Plan B®‚ – a low-dose, progestin-only emergency contraception product – available without a prescription. The FDA approved the Plan B®‚ four years ago, and is now considering an application from the drug’s manufacturer to make it available over the counter. A back-up method of birth control, Plan B‚ reduces pregnancy risk by up to 89 percent if taken in the first few days after contraception fails (say, a condom breaks), unprotected sex, or rape.

“Putting safe, effective back-up birth control on the drug store shelves next to condoms will give many more women a second chance to prevent pregnancy. We are hopeful the FDA will recognize the unprecedented medical and scientific consensus that supports over-the-counter emergency contraception,” said Kirsten Moore, President and CEO of the Reproductive Health Technologies Project.

Before the vote, organizations ranging from the American College of Obstetricians and Gynecologists to the American Academy of Family Physicians to the American Academy of Pediatrics to the National Hispanic Medical Association provided written and oral testimony pointing to volumes of research and real-world experience showing that emergency contraception is safe and effective for preventing pregnancy – and meets the FDA criteria to be sold without a prescription.

These health experts also argued that over-the-counter Plan B®‚ would enable more women to get this back-up method in time – especially on nights and weekends, when need is greatest and doctor’s offices are closed. The prescription requirement has been found to prevent some women from obtaining emergency contraception within its short window of effectiveness. Greater access to this back-up method could, in turn, help reduce the number of unintended pregnancies and abortions in the U.S.

Progestin-based emergency contraceptive products containing the same low-dose hormone as Plan B®‚ are already available over the counter or from a pharmacist (without a prescription) in more than 30 countries, including France and the United Kingdom. Here in the U.S., five states – Alaska, California, Hawaii, New Mexico, and Washington – currently allow women to get emergency contraception directly from a pharmacist.

Emergency contraception is safe and effective when self-administered – two major criteria for over-the-counter drugs in the U.S. The side effects of the progestin-only product are well-known and relatively minor (such as nausea, vomiting, dizziness, or fatigue), there are few contraindications, and the drug is not toxic. A woman can easily diagnose whether she needs emergency contraception and the dosage is always the same, so effective use requires only that she know how much time has elapsed since intercourse. (Emergency contraception – which works much like the daily birth control pills – is not effective once a woman has become pregnant, and should not be confused with the medical abortion drug, Mifeprex.)

Studies conducted in the U.S. show that adult women and teens understand over-the-counter labeling for emergency contraception – including how, when, and why to take it – and that they use the drug appropriately without medical supervision. These women know that emergency contraception cannot terminate a pregnancy or protect against STDs.

Research also indicates that removing barriers to obtaining emergency contraception (such as the need to fill a prescription) leads to more women using back-up birth control when they need it. For example, studies from around the world – including research in the U.S. – show that women who have gotten emergency contraception in advance are more likely to use it when they face a crisis. At the same time, these studies find that adult women and teens who have back-up birth control on hand are not more likely to have unprotected intercourse or to stop using a regular contraceptive method.

Educational efforts anticipated to coincide with launch of an over-the-counter product could help to increase awareness and use of this back-up birth control option. Experts believe that emergency contraception could prevent as many as half of the unintended pregnancies and abortions in the U.S. The U.S. currently has the highest rate of unintended pregnancies in the world – nearly 3 million each year. Half of these pregnancies occur among women who report that they are already using a regular method of contraception, demonstrating the need for a back-up method. Nationwide, only six percent of women report having ever used emergency contraception, according to the latest survey by the Kaiser Family Foundation.

The Reproductive Health Technologies Project coordinates Back Up Your Birth Control, an on-going public education effort launched in 2002 by medical organizations and public health advocates to raise awareness of emergency contraception in the U.S. The campaign, which features an annual Day of Action – March 22 in 2004 – works to inform women that there is a safe, effective way to prevent pregnancy after sex – and that women can get a prescription or dose of emergency contraception today, to keep on hand just in case. More information about emergency contraception is available at www.backupyourbirthcontrol.org.

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