The Honorable George W. Bush
President of the United States
1600 Pennsylvania Ave, N.W.
Washington, D.C. 20500
Dear Mr. President,
We write in reference to a May 15, 2006 letter from your Assistant Secretary of Health to members of Congress outlining the administration’s position on contraception. While we were pleased to learn of your sensible support for “…safe and effective products and services to assist responsible adults in making decisions about preventing or delaying conception,” the statement is directly at odds with the Food and Drug Administration’s extraordinary refusal to approve over-the-counter sale of emergency contraception products.
Since 2001, medical, public health and reproductive rights organizations have been urging the FDA to make emergency contraception available without a prescription. Unfortunately, the agency dragged its feet and deployed procedural roadblocks for years rather than make a decision on the matter. Last month, the agency finally denied our citizen’s petition for over-the-counter status. The reasons for this refusal appear to have nothing to do with the safety or effectiveness of Plan B – the only considerations that are the proper purview of the FDA. Decades of scientific research and use of emergency contraception around the world have clearly proven that Plan B is safe and effective for women of all ages. Indeed, the Government Accountability Office in November 2005 released a report finding that the agency’s refusal to make the emergency contraceptive available without a prescription was “unusual” and “not typical of” previous decisions on other over-the-counter drugs.
We at the Center for Reproductive Rights are now engaged in litigation against the FDA in the U.S. District Court for the Eastern District of New York to compel the agency to approve non-prescription use of Plan B. Every 10.5 seconds, an unplanned pregnancy occurs in the U.S. – an estimated three million such pregnancies every year. And each year, 1.29 million end in abortion. Researchers at the Guttmacher Institute, a nonprofit reproductive health research organization, have concluded that better access to emergency contraception could prevent half of those pregnancies, including those that now end in abortion. Had the FDA approved emergency contraceptives for over-the-counter use when we submitted our citizen’s petition, many of the 16 million unplanned pregnancies – and subsequent abortions – that occurred in the five years since could have been avoided. If the administration indeed supports safe and effective products and services to assist responsible adults in making decisions about preventing or delaying conception, then there is no reason for its failure to support the availability of emergency contraception.
It is long past time for the FDA to stop the delays, obfuscation and outright refusal to acknowledge what basic science demonstrates. We urge you to direct the agency to take immediate steps to make Plan B readily available to the millions of American women who wish to use this scientifically proven safe and effective form of emergency contraception.
We look forward to your reply.
Center for Reproductive Rights