A federal judge has ordered FDA to allow nonprescription sales of the Plan B emergency contraceptive to 17 year olds and to reconsider whether to make the drug available to women of all ages without a prescription.
Judge Edward R. Korman’s March 23 ruling could draw the Obama administration and the FDA leadership into either defending one of the agency’s most contentious decisions under the Bush administration, or agreeing to ease restrictions on access to the emergency contraceptive, commonly called the “morning after pill.”
Questions on how the agency will respond could surface in Senate confirmation hearings for Health and Human Services Secretary-designate Kathleen Sebelius, who has already drawn some criticism for abortion-related policies she addressed as Kansas governor. Comments on the agency’s response to this court order could also mark FDA Commissioner-designate Margaret “Peggy” Hamburg’s confirmation proceedings.
Ruling in the U.S. District Court for the Eastern District of New York, Korman ordered FDA to rescind the limit on nonprescription Plan B access to women 18 years old and over because “no useful purpose would be served by continuing” to require that 17 year olds have prescriptions for the drug.
FDA must comply with the order within 30 days if it does not appeal and seek a stay of Korman’s order.
The ruling highly critical of FDA attrracted coverage across the country, such as this Washington Post article, and outside the U.S. as well, including this Euronews 24 item.
Korman said the requirement that Plan B be distributed only by pharmacists can continue. FDA's Center for Drug Evaluation and Research said it is reviewing the ruling.
The judge criticized FDA's handling of Barr Pharmaceuticals' switch application for Plan B (levonorgestrel). The agency's actions that led to the dual-status distribution "were arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making," he said.
FDA approved a Plan B switch under a unique dual-status scheme in August 2006 after Barr, which has since been acquired by Teva Pharmaceuticals, offered to conduct a tracking program to determine whether stores comply with the age restriction.
However, critics of FDA argued the dual-status designation was orchestrated to appease Capitol Hill interests and facilitate former Commissioner Andrew von Eschenbach's confirmation to the post.