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Court Orders FDA to Reconsider Decision on Morning-After Pill Restrictions
Activists Say FDA Restrictions for Plan B Are Based on Anti-Birth Control Politics, Not Science
NEW YORK - March 23 - Today, the U.S. District Court for the Eastern District of New York issued a ruling that the Food and Drug Administration (FDA) must reconsider its decision in the case of Tummino, et al. v. von Eschenbach in which plaintiffs challenged FDA policies regarding the Morning-After Pill, often referred to by its brand name, Plan B. Plaintiffs claimed that restrictions were based on anti-birth control politics and political pressure not science.The FDA must not only reconsider Plan B's over-the-counter (OTC) status without any age or other restrictions, but must also make it available to women 17 and older without a prescription.
"We are thrilled that immediate access to the Morning-After Pill will be expanded for younger women and that the FDA will have to reconsider whether Plan B should be approved without any restrictions," said Anne Tummino, lead plaintiff and Morning-After Pill Conspiracy Coalition Coordinator. "The FDA bowed to political pressure from the Bush Administration and imposed medically unnecessary age restrictions on a drug that is safe and effective justice will now be served."
In addition to claims that the FDA violated its own regulations in its decision-making process regarding OTC access to Plan B, plaintiffs also charged that the agency violated womens constitutional rights to privacy and equal protection by unlawfully restricting access to contraception and discriminating against women who are the exclusive users of Plan B.
Following legal and organizing pressure after considerable delays by the FDA, the agency approved the switch of Plan B from prescription only to over-the-counter use in August 2006, but only for women 18 and older. In practice, this means that Plan B can only be obtained from behind a pharmacy counter for women 18 and older, but only if they show identification. Plaintiffs seek to make Plan B available to all women regardless of age and without any behind-the-counter restrictions or identification requirements.
"The court's decision is a victory for women and expands reproductive rights and access to contraception for women all over the country," said Andrea Costello, CCR Cooperating Attorney in the case.
In its decision, the Court upheld earlier findings in the case which concluded that there was a strong showing of bad faith on the part of the FDA in its decision making process to switch Plan B to an over-the-counter drug. Deposition testimony from high-level FDA officials and documents obtained in discovery also establish that the agencys decision was not based on science, but, rather, due to improper political influence and ideology.
Erin Mahoney, plaintiff and organizer with the Morning-After Pill Conspiracy Coalition organizer said, "In the streets and in court, women have been fighting for unrestricted access to the morning-after pill for years. We will keep fighting until the FDA does the right thing and allows all women to have access to Plan B without any restrictions."
Originally filed on January 21, 2005, plaintiffs asked the court to order the FDA to make Plan B available without a prescription for women of all ages. Plaintiffs asserted that the FDA has violated women's constitutional rights to privacy and equal protection by unlawfully restricting access to contraception and discriminating against women who are the exclusive users of Plan B.
Plaintiffs argued that decades of scientific research and anecdotal evidence from Plan B users showed that the drug is effective and safe for self-medication. Among other supporting evidence, plaintiffs cited an internal memo in which the FDA acknowledged that the clinical data clearly support[ed] making Plan B available without a prescription for all age groups, and that such approval would be consistent with previous decisions on other products.
CCR represents several feminist activist plaintiffs in the lawsuit, in cooperation with the Center for Reproductive Rights as lead counsel. Plaintiffs also include: the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health and a number of young women and their parents.
The activist plaintiffs are organizers with the Morning-After Pill Conspiracy. Founded in January 2004, the Morning-After Pill (MAP) Conspiracy is a coalition of feminist organizations leading the grassroots fight against restrictions on the MAP. The MAP Conspiracy uses a variety of creative methods to protest the FDA, the Bush administrations stance on the drug, including speak-outs and civil disobedience. Its goal is to highlight the injustice of the restrictions and to show that women are the real experts when it comes to birth control. Visit www.mapconspiracy.org.