February 9, 2012 — A coalition led by the Center for Reproductive Rights on Wednesday requested permission to formally reopen a 2005 lawsuit challenging the age and point-of-sale restrictions on the emergency contraceptive Plan B and similar products, Reuters reports (Dye, Reuters, 2/8). The group asked U.S. District Judge Edward Korman to order FDA to make EC available to people of all ages without a prescription within 30 days (Schoenberg/Frier, Bloomberg, 2/8).
FDA on Dec. 7 was set to eliminate the current requirement that women prove they are at least 17 years old or obtain a prescription to purchase Plan B. However, HHS Secretary Kathleen Sebelius issued a memo stating that she was invoking her authority to overrule the decision because the drugmaker did not provide "data on all ages for which the drug would be approved" for nonprescription use.
The next week, Korman said FDA's action on Plan B rendered moot a request from CRR to hold the agency in contempt for delaying a decision on the drug. However, Korman invited CRR to file the appropriate legal motions to proceed with other elements of its case over whether the government should lift the sale restrictions. Sebelius could be added as a defendant, he said (Women's Health Policy Report, 12/14/11).
CRR's latest filing requests that Sebelius be added as a defendant. Suzanne Novak, senior staff attorney for CRR, said, "FDA has continually treated emergency contraception completely different than it has any other medication." CRR is "asking the court to recognize that the FDA has failed to meet is obligation to the public and make decisions on science, rather than politics," Novak said (Bloomberg, 2/8).