Tummino v. von Eschenbach: FDA Decision 2009


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.  The Center sued the FDA in 2005.

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."

Download PDF of the March 2009 FDA decision below.