FDA Ignores Its Scientific Advisors, Rejects Over-the-Counter Status for Emergency Contraception

From: The Alan Guttmacher Institute

On May 6, the Food and Drug Administration (FDA) refused to allow consumers to purchase Plan B emergency contraceptive (EC) pills without a prescription.

Non-prescription status for EC had been overwhelmingly recommended by the FDA’s own advisory committees, as well as by more than 70 of the nation’s leading medical and public health organizations, including the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American Public Health Association.

Half of pregnancies in the United States are now unintended, and about half of these end in abortion. Research from The Alan Guttmacher Institute shows that EC averted over 100,000 unintended pregnancies, including an estimated 51,000 abortions, in 2000.   EC pills contain a concentrated dose of the same hormones found in ordinary birth control pills. (Unlike the so-called “abortion pill,” EC does not contain mifepristone or RU-486 and will not affect an established pregnancy.)

When taken within 72 hours after unprotected intercourse, EC can prevent a pregnancy from occurring. The method is more effective the sooner it is taken, and delays caused by the need to obtain and fill prescriptions (particularly over weekends and holidays) can prevent women from obtaining EC when they need it.

While the May 6 ruling means that women in most of the country will continue to have to take extra time to obtain and fill a prescription for EC, the method is safe, legal and (with a prescription) FDA-approved. In addition, five states allow pharmacists to dispense EC without a prescription under certain circumstances, and six states require hospital emergency rooms to provide EC-related services to women who have been sexually assaulted.

To learn more about EC and its potential to avert unintended pregnancies and abortions, click here http://www.guttmacher.org/media/supp/ec121702.html.

For more information on the need to increase public awareness of EC, click here http://www.guttmacher.org/pubs/journals/gr050403.html.

For more information on steps being taken to improve access to EC, click here http://www.guttmacher.org/pubs/journals/gr050510.html.

To learn about what states are doing to improve access to EC, see Increasing Access to Emergency Contraception Through Community Pharmacies: Lessons from Washington State http://www.guttmacher.org/pubs/journals/3317201.html  and State Policies in Brief: Access to Emergency Contraception http://www.guttmacher.org/pubs/spib_EC.pdf.