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07.31.06 - The Center for Reproductive Rights issued the following statement from Nancy Northup, president of the Center for Reproductive Rights, in response to today's FDA announcement regarding Plan B:
The timing of the FDA's announcement is highly suspect given the mounting pressure of two significant hearings involving the agency: tomorrow's Senate confirmation hearing of Dr. Andrew C. von Eschenbach; and a scheduled hearing on Thursday, August 3rd, by the Center for Reproductive Rights regarding its request to subpoena documents from the White House in its Tummino v. von Eschenbach lawsuit.
A recent deposition of a senior FDA official by the Center for Reproductive Rights indicates the White House was exerting influence on the FDA regarding Plan B in order to "appease the administration's constituents." That admission was one of the bases of our decision to request the White House subpoena, however, the government has now asked that the subpoena hearing be postponed.
While we hope the FDA has finally decided to stop playing politics with Plan B, we remain skeptical, especially given the new requirements the FDA is placing on Barr Pharmaceuticals in order to obtain approval. We believe that by imposing these additional hurdles the FDA will continue to violate the Constitutional rights of women in need of emergency contraception. We will push ahead with our request to subpoena the White House and continue to vigorously pursue our case against the FDA.
It is time for the FDA to make Plan B available to the millions of women who wish to use a drug that has been proven scientifically safe and effective. If the FDA continues to refuse to do their job, we will use the courts to do it for them.
About today's FDA announcement Ms. Annie Tummino, lead plaintiff in the Center's case said, "While we hope that this latest move by the FDA will actually make the morning-after pill available without a prescription, the proposal of an age limit of 18 is completely outrageous. There is simply no medical reason for it."
The lawsuit Tummino v. von Eschenbach was filed on January 21, 2005, by the Center for Reproductive Rights in the U.S. District Court for the Eastern District of New York on behalf of the Association of Reproductive Health Professionals (ARHP), National Latina Institute for Reproductive Health, and individuals from a grassroots advocacy group, the Morning-After Pill Conspiracy.
Since 2001, medical, public health, and reproductive rights organizations have been requesting that the FDA to make the ‘morning-after pill' available without a prescription. Unfortunately, for years, the agency has dragged its feet and deployed procedural roadblocks rather than make a decision on the matter. Last month, the agency finally denied the Center for Reproductive Rights' citizen's petition for granting emergency contraception over-the-counter status. This decision ignored the advice of its own scientific experts as well as overwhelming medical evidence from around the world that the drug is safe and effective.
Every 10.5 seconds, an unplanned pregnancy occurs in the United States-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 the citizen's petition, many of the 16 million unplanned pregnancies-and subsequent abortions-that occurred in the five years since could have been avoided.