FDA Says Will Not Appeal New York Federal Court Decision
Today, 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. The FDA will also reconsider its previous decision to limit over-the-counter access to the emergency contraceptive to women 18 and older. The announcement follows a March 23 ruling by the U.S. District Court for the Eastern District of New York that the agency’s initial decision was based on politics and ideology rather than science. The court ordered the FDA to extend over-the-counter access to 17-year-olds by April 23.”We commend the FDA for taking swift action to ensure that its decisions on Plan B are based solely on the drug’s safety and efficacy,” said Nancy Northup, president of the Center for Reproductive Rights, which brought the suit against the FDA. “It is a key step for the agency as it seeks to restore confidence in its ability to safeguard public health and leave politics at the lab door.”The Center sued the FDA in 2005 for failing to grant over-the-counter status to Plan B against the advice of its scientific experts and in violation of its own procedures and regulations. In 2006, the FDA agreed to make Plan B available without a prescription, but only to women 18 and over and only behind the pharmacy counter. The Center continued to pursue its lawsuit, Tummino v. von Eschenbach, to ensure that Plan B would be granted true over-the-counter status and made available to all women, including young women who might benefit most from this form of contraception.
In its decision, 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.”
The Center for Reproductive Rights filed the lawsuit on behalf of the Association of Reproductive Health Professionals (ARHP), National Latina Institute for Reproductive Health, individuals from a grassroots advocacy group, the Morning-After Pill Conspiracy, and parents who seek over-the-counter access for their daughters.