Court Orders FDA to Reconsider Decision on Morning-After Pill Restrictions

NEW YORK - 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." 

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.

For more information
on the case, click
here. To download a copy of the decision, click
here.

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.