Tuesday, March 24, 2009

Court Tells FDA To Reconsider "Plan B" Restrictions

In Tummino v. Torti, (ED NY, March 29, 2009), a New York federal district court ordered the U.S. Food and Drug Administration to reconsider the restrictions it previously placed on distribution of "Plan B", an emergency contraceptive. Under FDA rules adopted in 2006 (FDA's Q&A), women 18 and over may obtain the drug without a prescription, but only upon showing identification to a pharmacist. It is available only by prescription to women 17 and under. The court concluded that the FDA's decision-making on the drug had departed from normal procedures, was motivated by political considerations, and was not the result of reasoned and good-faith agency decision making. (See 2005 GAO Report.) The court also ordered that within 30 days the FDA modify its rules to make Plan B available to 17-year olds on the same non-prescription basis that it is now available to those 18 and over. Reuters reports on the decision.

A press release from Pharmacists for Life International in reaction to the ruling said: "Hundreds of women have had serious side effects from Plan B as it has killed millions of preborn babies." The Family Research Council complained that: "This ruling jeopardizes girls' health and the ability of parents to care for their daughters' physical and emotional well-being." However Advocates for Youth applauded the decision, saying that it gives the FDA a chance to "ensure that science, not ideology, dictates all future decisions."