Women’s Health Advocates Support Court Action
To Expand Access to Emergency Contraception
FOR IMMEDIATE RELEASE
February 8, 2012
Contact: Lydia Stuckey
lstuckey@rhtp.org
Office: 202-530-4401
Mobile: 317-441-7750
(Washington, DC) – Today, the Center for Reproductive Rights’ reopened their lawsuit against the
Food and Drug Administration (FDA) for imposing unnecessary age restrictions on emergency
contraception and added Department of Health and Human Services Secretary Sebelius as a
defendant.
“We applaud the Center for Reproductive Rights for its continued effort to seek a legal remedy to this
incredibly frustrating situation. In December of 2011, Secretary Sebelius unnecessarily intervened and
injected politics into science by overruling the Food and Drug Administration’s decision to approve the
sale of Plan B One-Step on pharmacy shelves. Secretary Sebelius’ decision is bad policy and sets a
dangerous precedent for future politicizing of the drug review process.
“We hope Judge Korman will hold HHS accountable for making its decision in an arbitrary and
capricious manner and FDA will be able to move forward with the available data, which is both robust
and reassuring.
“On-the-shelf access to emergency contraception is the best way to realize the full potential of this timesensitive product. In a country where nearly half of all unintended pregnancies are unplanned, effective
and accessible birth control options like emergency contraception are not just a case of convenience, but
an urgent health need.”
Statement by Dr. Susan Wood, an Associate Professor at George Washington University's School
of Public Health and former Assistant Commissioner for women's health at the FDA:
“It has been clear since at least 2004 that emergency contraceptive pills, like Plan B One-Step, are safe
and effective, and need to be available to all women who need it. The numerous delays and rationales to
keep it prescription and behind the counter have never been based on good science or good
medicine. HHS is continuing to block the path forward through the unprecedented action of overturning
the FDA Commissioner's decision. This lawsuit is one way to remove those barriers, and to require
FDA and HHS to stay true to the mission of protecting and promoting the public's health.”
BACKGROUND: In March 2009, a U.S. Federal District Court ordered the FDA to immediately make
Plan B available over-the-counter to 17 year olds and to reconsider making emergency contraception
available without a prescription for consumers of all ages, citing the overwhelming consensus among
scientists at the FDA in support of the switch without restrictions. The FDA complied with the first of
these two directives in 2009. In 2010, CRR filed a contempt of court motion to force the FDA to
respond to the second directive. The FDA waited until December 12, 2011 – the day before this hearing
– to respond, denying the removal of the age restriction on emergency contraceptive products. As a
result, Judge Korman denied the motion of contempt as moot, but invited CRR to reopen its lawsuit
against the FDA and add Secretary Sebelius as a defendant.
Emergency contraception is a safe, effective back-up method of birth control that can prevent pregnancy
in the first few days after unprotected sex or contraceptive failure. Current levonorgestrel emergency
contraceptive products on the market are Plan B® One-Step and two Plan B® generics.
For more information on emergency contraception: www.rhtp.org
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