For immediate release: March 23, 2009

Court Rules FDA Must Reconsider its Decision About Morning-After Pill Restrictions

Activists Say FDA’s Restrictions for Plan B Are Based on Anti-Birth Control Politics, Not Science

Contact:   Annie Tummino, atummino@gmail.com, (917) 842-5306
Andrea Costello, acostello@filsinc.org, (352) 246-5690

New York, N.Y. – 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 challenge the FDA’s policies regarding the “Morning-After Pill,” often referred to by its brand name, Plan B.  The Court’s order requires the FDA to not only reconsider whether to approve Plan B for over-the-counter status without any age or other restrictions, but must also make it available to women 17 and older without a prescription. Scientists and medical experts, including the FDA’s own scientific review panel, agree -- Plan B has been proven safe and effective for women, including young women.  The only explanation for denying young women the ability to control their reproduction and for imposing other restrictions on Plan B is political pressure based on anti-birth control politics. 

Plaintiffs asserted that the FDA violated its regulations by relying on anti-birth control politics, rather than scientific evidence, in its decision making process regarding whether to approve the drug for over-the-counter access.  Plaintiffs also charged that the agency 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.

 
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. 

 
“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.”

 
“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 agency’s 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.”

 
Background

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: he Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health and a number of young women and their parents.

 
For more information on Tummino, et al. v. von Eschenbach: http://www.wnyc.org/shows/atc/latest

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 administration’s 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.

 
The Center for Constitutional Rights is dedicated to advancing and protecting the rights guaranteed by the United States Constitution and the Universal Declaration of Human Rights. Founded in 1966 by attorneys who represented civil rights movements in the South, CCR is a non-profit legal and educational organization committed to the creative use of law as a positive force for social change. Visit www.ccrjustice.org

Checks may be made payable to "Gainesville Area NOW" and mailed to:
MAP Conspiracy
c/o Gainesville Area NOW
P.O. Box 2235
Gainesville, FL 32602

The coalition was founded in January 2004 when the MAP was only available in the U.S. through a doctor’s prescription. We believe that grassroots organizing by women was a major factor in the FDA’s decision in 2006 to allow women, ages 18 and up, to purchase the pill at pharmacies, without a prescription. Nine of our founding members are also plaintiffs in a lawsuit against the FDA (Tummino vs von Eschenbach) charging the agency with discrimination against women and failure to follow medical science in their decisions on the MAP. The lawsuit could result in the removal of the age restriction and behind-the-counter status. 

The Morning-After Pill Conspiracy uses a variety of creative methods to protest the FDA and the Bush Administration’s stance on the MAP, including speak-outs and civil disobedience. Our goal is to highlight the injustice of the restrictions and to show that women are the real experts when it comes to birth control.

To read more about our history, Click here. 

• The Women's Liberation Birth-Control Project (formerly  New York NOW  Reproductive Rights Task Force)
• Gainesville Area (FL) National Organization for Women (NOW)
• Florida NOW Young Feminist Task Force
• Gainesville (FL) Women’s Liberation
• University of Florida Campus NOW
• New Morning Foundation - South Carolina