31: FDA Rejects Over-the-Counter Sales of Morning-After Pills

By Susan Karlin|Monday, January 03, 2005

In May the Food and Drug Administration overruled its science advisers and withheld approval for over-the-counter sales of a morning-after contraceptive known as Plan B. The decision outraged many health care professionals. “It is morally repugnant, a tragedy for American women, and a stain on the reputation of an agency that calls itself ‘evidence based,’ ” says Vivian Dickerson, president of the American College of Obstetricians and Gynecologists. “Accidents happen, coercion happens, and there is a public-health imperative not to hold women hostage by hampering them from timely access to postcoital contraception.” Joining the chorus of criticism, the American Medical Association passed a resolution at its annual convention urging physicians to circumvent the ruling by giving patients advance prescriptions for the contraceptive.

Plan B is an emergency backup step when traditional birth-control methods—condoms, pills, diaphragms, IUDs—are forgotten, break, or slip out. It consists of two pills, ingested 12 hours apart, containing the synthetic hormone levonorgestrel. Taken the morning after unprotected intercourse, levonorgestrel prevents a fertilized egg from sticking to the uterine wall and can cut the chance of pregnancy by 85 percent. But time is of the essence because the contraceptive will not dislodge a firmly implanted egg.

David Grimes, vice president of biomedical affairs at Family Health International in Research Triangle Park, North Carolina, charged that the FDA action was influenced by the efforts of antichoice Republicans who preach sexual abstinence to prevent pregnancy. In the August issue of Obstetrics & Gynecology Grimes wrote, “Defying the published evidence, the international experience, the recommendation of two FDA advisory committees, and the advice of its own scientific staff, the agency caved in to political pressure.”

Grimes argues that the policy is detrimental to at-risk teenagers with limited access to medical care. “The irony is that the FDA approved over-the-counter sales of home defibrillators,” he adds. “So a 14-year-old can buy a device to deliver an electric shock to another person, yet she cannot buy 1.5 milligrams of levonorgestrel for herself.”

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