May 2, 2013 —The Department of Justice on Wednesday said it would appeal a federal court ruling ordering FDA to make emergency contraception available without age or point-of-sale restrictions, the New York Times reports. DOJ also requested a stay on the court order pending results of the appeal.
In an April 5 ruling, U.S. District Judge Edward Korman said HHS Secretary Kathleen Sebelius had prioritized politics over science in 2011 by overruling FDA's recommendation that EC be made available to people of all ages without a prescription. Korman gave FDA 30 days to comply.
DOJ's decision follows FDA's announcement on Tuesday that it has approved Teva Pharmaceuticals' request to sell its EC drug Plan B One-Step over the counter to people ages 15 and older with proof of age.
Details of Appeal
DOJ will argue in its appeal that Korman did not have the authority to order FDA to take a specific action and should have instead told the agency to reconsider its decision. DOJ also will contend the judge did not have authority to extend his order to all forms of EC because the original lawsuit only focused on an older, two-dose version of Plan B (Belluck/Shear, New York Times, 5/1).
"The Court's Order interferes with and thereby undermines the regulatory procedures governing FDA's drug approval process," DOJ said, adding, "A drug approval decision involves scientific judgments as to whether statutory and regulatory factors are met that warrant deference to those charged with the statutory responsibility to make those decisions."
The notice of appeal does not change FDA's decision on Plan B One-Step sales for people ages 15 and older. DOJ cited that decision in its filing Tuesday, arguing that the move would ensure that "all of the plaintiffs in this case (including the youngest of them) now have access without a prescription and without significant point-of-sale restrictions on at least one form of" EC (Kliff, "WonkBlog," Washington Post, 5/1).
DOJ asked for a ruling on the stay request by the end of Thursday, which would allow it to pursue an emergency stay from an appeals court if the first request is denied. DOJ lawyers said they are seeking a quick decision because of the looming deadline to comply with Korman's order.
DOJ argued that a stay is needed "to prevent public uncertainty" about the status of EC availability during the appeal process. The department added that if EC availability is expanded and later reversed, women seeking EC might erroneously think they could access it without a prescription (Norman, CQ HealthBeat, 5/1).
Nancy Northup -- president and CEO of the Center for Reproductive Rights, which filed the lawsuit that resulted in Korman's decision -- said in a statement, "We are deeply disappointed that just days after President Obama proclaimed his commitment to women's reproductive rights, his administration has decided once again to deprive women of their right to obtain emergency contraception without unjustified and burdensome restrictions." She noted that the "political maneuverings of the last two presidential administrations" have restricted access to EC "for more than a decade."
Cecile Richards -- president of Planned Parenthood Federation of America -- said, "The Obama administration took an important step forward earlier this week by moving [EC] out from behind the pharmacy counter and making it available to people ages 15 and older, and we continue to believe that access should be expanded further."
Susan B. Anthony List President Marjorie Dannenfelser gave a mixed reaction. She said the conservative group "agree[s] with the administration's decision to appeal Judge Korman's ruling" but that FDA's decision on Plan B One-Step would "endanger the lives of teen girls" (Smith, Politico, 5/1).