FDA Reverses EC Decision
07 May 2004
by Anai Rhoads
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AnaiRhoads.org - The Food and Drug Administration (FDA) reversed a 2003 decision Thursday, which once allowed the Morning After Pill (Plan B) to be sold over-the-counter.
The decision came as a shock to many women who relied on Plan B to abort fertilised eggs before, during, and after implantation. Having Plan B readily accessible, the women had time to use it within the 72 hours required post-intercourse to assure the possible pregnancy would be terminated.
"Emergency contraception is designed to respond to emergency situations -- emergencies that are a result of unwanted sex or contraceptive failure," said NOW President Kim Gandy. "Once a woman is raped, or a condom breaks, the clock begins ticking -- emergency contraception is most effective for only 72 hours after sex. So over-the-counter availability is the only way for some women to obtain EC in time to prevent a pregnancy."
Barr Laboratories, maker of the Plan B brand morning after pill, discussed plans with the FDA in 2003 to allow the morning after pill to be sold over-the-counter. A joint panel of FDA advisers voted 23-4 to support the non-prescription availability of the drug. This vote was strongly approved the FDA staff at the time. However, one of the few negative votes came from a controversial Bush appointee, Dr. W. David Hager, who is known to deny birth control to unwed women in his private practice, and has even spoken against the use of condoms and birth control outside of the bounds of marriage.
"The FDA is playing politics with women's lives and contributing to the deterioration of public health in this country," said Gandy. "Plan B is safe, effective, and could prevent thousands of unwanted pregnancies. The FDA has set aside its mission and caved to political pressure from the Bush administration and its allies who oppose birth control."
Both the American Medical Association and the American College of Obstetricians and Gynecologists approve of the change to non-prescription status. According to Planned Parenthood, it is estimated that over three million American women have unplanned pregnancies every year with more than half ending in abortion.
The drug itself is not completely foolproof. According to Barr Laboratories, using the pill within three days post-unprotected intercourse, the user only has an 89% chance of termination. The remainder 11% uncertainty will fail to abort the unwanted pregnancy. As a means of birth control, this method may be viewed as secondary to an actual abortion.
Alaska, California, Hawaii, New Mexico and Washington State currently sell EC without prescription.
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