Food and Drug Administration Puts Politics Before Women's Health; ACLU Says Investigation Warranted

May 12, 2004 12:00 am

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WASHINGTON - Reacting to the Food and Drug Administration's decision last week to deny over-the-counter status for the emergency contraceptive known as Plan B, the American Civil Liberties Union joined members of Congress and other national advocacy groups today in calling for an investigation into the approval process.

"The FDA's decision last week to prevent over-the-counter sales of Plan B makes clear the administration's unabashed and unconscionable willingness to put anti-choice politics before science and women's health," said Laura W. Murphy, Director of the ACLU Washington Legislative Office. "Politics cannot be allowed to trump science and the public health; someone needs to be held accountable."

In December of 2003, an FDA advisory panel of medical experts voted 23-4 to allow Plan B to be made available without a prescription. The FDA staff as well as the American College of Obstetricians and Gynecologists, the American Public Health Association and other medical organizations supported this recommendation.

In concluding that emergency contraceptives are safe and effective, the FDA advisory panel considered a study showing that access to such contraceptives does not cause adolescents to have more unprotected sex or to stop using contraception.

Emergency contraceptives must be taken within 72 to 120 hours after unprotected intercourse to prevent pregnancy, but most experts agree that it is more effective the sooner it is taken. This narrow window makes ready access to emergency contraceptives critical, and requiring a prescription places an unnecessary burden, the ACLU said.

The ACLU also said that the FDA's decision is particularly harmful to survivors of sexual assault. Numerous national studies show that the majority of rape victims do not receive emergency contraceptives in the emergency room. Making emergency contraceptives available in pharmacies without a doctor's prescription would mean that at least one injury from the assault -- the possibility of pregnancy -- could be quickly and safely alleviated.

Making emergency contraceptives available over-the-counter would allow women to prevent unintended pregnancies from occurring. In 2000 alone, emergency contraceptives prevented approximately 51,000 abortions, the Alan Guttmacher Institute estimated. Emergency contraception prevents pregnancy, but does not terminate a pre-existing pregnancy.

"For women who cannot afford to see a doctor, whose doctor's office is closed during the critical period, or who cannot obtain an appointment within the short window, the prescription requirement serves as a major barrier to getting the drug within the necessary time frame," Murphy said. "If this administration was seriously committed to reducing the need for abortions in this country, ensuring access to emergency contraceptives would be an appropriate measure."

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