Tummino v. von Eschenbach (NY)

03.23.09 - Filing date: 01/21/2005

State: New York

Plaintiff(s): Annie Tummino; Erin T. Mahoney; Carol Giardina;  Kelly Mangan; Stephanie Seguin; Lori Tinney; Jennifer Brown; Candace Churchill; and Francie Hunt; Association of Reproductive Health Professionals; and National Latina Institute for Reproductive Health.

Center Attorney(s): Suzanne Novak, Janet Crepps

Co-Counsel/Cooperating Attorneys: Andrea Costello and Natalie Maxwell (for the individual plaintiffs)

Summary: On March 23, 2009, the Center scored a major victory when a federal court ruled that the U.S. Food and Drug Administration had put politics before women's health when it decided to limit over-the-counter access to the emergency contraceptive Plan B to women over 18.  The U.S. District Court for the Eastern District of New York ordered the agency to reconsider its decision. It also ordered the FDA to act within 30 days to extend over-the-counter access to 17-year-olds. On April 22, 2009 the U.S. Food and Drug Administration announced that it will clear the way for Plan B's manufacturers' to make the "morning-after pill" available without a prescription to 17-year-olds.

This ruling is the culmination of a years-long fight by the Center to make emergency contraception available without restrictions for all women.  In 2001, the Center, along with the Reproductive Health Technologies Project and numerous women’s health organizations, filed a Citizen’s Petition to the Food and Drug Administration (FDA), urging the agency to switch emergency contraception drugs from prescription-only to over-the-counter status.  Shortly thereafter, the manufacturer of the emergency contraceptive product Plan B™ submitted its own application to the FDA seeking to make Plan B™ available over-the-counter.  The FDA responded to our Citizens Petition and to the Plan B™  application with years of unexplained delay.  After four years of waiting, the Center filed suit in federal court against the FDA, alleging that the agency’s failure to approve Plan B for over-the-counter use impermissibly denied women access to EC.  

In July of 2006, the FDA finally acted on the Plan B™ application and Citizen’s Petition, announcing that it would approve the distribution of emergency contraception without a prescription only at pharmacies and only for women 18 or older who could produce government-issued identification as proof of age.  In refusing to allow women under 18 to obtain Plan B™ without a prescription, the FDA went against the overwhelming recommendations of its own scientific review staff.  Moreover, no drug besides Plan B is subject to a two-tiered prescription/over-the-counter structure based on age.  And no other over-the-counter drug requires production of identification for purchase.  The testimony of FDA employees and officials makes clear that the FDA's decisions regarding emergency contraception were made on the basis of politics, rather than on considerations of the drug's safety and efficacy.  This influence appears to have come from as far up as the White House.

The Court found that the FDA "acted in bad faith and in response to political pressure," "departed in significant ways from the agency's normal procedures," and engaged in "repeated and unreasonable delays." In addition, the court found that the FDA's justification for denying over-the-counter access to 17 year olds "lacks all credibility," and was based on "fanciful and wholly unsubstantiated ‘enforcement' concerns."