May 13, 2013 — A federal judge on Friday refused to stay his April 5 ruling that ordered FDA make emergency contraception available without age or point-of-sale restrictions, the Los Angeles Times reports (Morin, Los Angeles Times, 5/11).
Last week, the Department of Justice announced an appeal of U.S. District Judge Edward Korman's ruling and requested a stay of his court order pending results of the appeal. DOJ argued that a stay is needed "to prevent public uncertainty" about the status of EC availability during the appeal process (Women's Health Policy Report, 5/8).
Korman allowed DOJ lawyers to seek a suspension of his decision with the 2nd U.S. Circuit Court of Appeals. The federal government has until noon on Monday to do so (Norman, CQ HealthBeat, 5/10).
Details of Stay Ruling
In his ruling, Korman wrote that DOJ's appeal "is frivolous and taken for the purposes of delay" (Dye, Reuters, 5/10). He explained that if a stay is granted, "it will allow the bad-faith, politically motivated decision of [HHS] Secretary [Kathleen] Sebelius, who lacks any medical or scientific expertise, to prevail -- thus justifiably undermining the public's confidence in the drug approval process" (Shear, New York Times, 5/10).
Korman also said that remanding the case back to FDA -- which DOJ requested in its appeal -- "ignores the fact that the FDA found the drug was safe and could be used properly without a doctor's prescription" (Los Angeles Times, 5/11). He pointed out that the "cause of the rejection of over-the-counter sale of ... [EC] was [Sebelius]" and "[s]he has not changed her position." (New York Times, 5/10). Such "rare circumstances," he argued, would make a remand "not only unnecessary but ... an abuse of discretion" (Bray, Wall Street Journal, 5/10).
Criticism of DOJ Appeal
In addition, the judge castigated DOJ for suggesting that the unrestricted sale of EC would create "uncertainty" for women while the appeals are ongoing.
He wrote that "this silly argument ignores the fact it is the government's appeal from the order that sustained the judgment of the commissioner of the F.D.A. that is the cause of any uncertainty, and that that appeal is taken solely to vindicate the improper conduct of [Sebelius] and possibly for the purpose of further delaying greater access to [EC] for purely political reasons" (New York Times, 5/10). Korman added that the argument also "assumes that defendants have a likelihood of success on the merits" and constitutes "an insult to the intelligence of women" (Wall Street Journal, 5/10).
Nancy Northup -- president of the Center for Reproductive Rights, which is a plaintiff in the dispute -- in a statement praised Korman's decision, noting, " Judge Korman's sound ruling simply orders the government to do what the experts at FDA have been trying to do for years: to put politics aside and let science guide us to a policy that makes emergency contraception readily accessible to all women when they need it most urgently."
DOJ declined to comment on the decision (Los Angeles Times, 5/11).