Some morning-after over-counter pill sales allowedBy LARRY NEUMEISTER and LAURAN NEERGAARD , Associated Press
Jun. 5, 2013 5:12 PM ET
NEW YORK (AP) — Generic versions of emergency contraception can be sold without a prescription or age restrictions while the federal government appeals a judge's ruling allowing the sales, an appeals court said Wednesday.
The brief order issued by the 2nd U.S. Circuit Court of Appeals in Manhattan permitted two-pill versions of emergency contraception to immediately be sold without restrictions, but the court refused to allow unrestricted sales of Plan B One-Step until it decides the merits of the government's appeal. It did not specify why the two-pill versions were being allowed now, though it said the government failed to meet the requirements necessary to block the lower-court decision.
The order was welcomed by the Center for Reproductive Rights, where President Nancy Northup called it a "historic day for women's health."
"Finally, after more than a decade of politically motivated delays, women will no longer have to endure intrusive, onerous and medically unnecessary restrictions to get emergency contraception," she said in a statement.
The center's litigation director, Julie Rickelman, said the government has two weeks to decide whether to appeal the 2nd Circuit's decision on the stay to the full appeals court or the Supreme Court. Even if there is no appeal of the stay ruling, it was unclear how soon drugstores would move the two-pill emergency contraception from behind the counter. She said she hoped the pills would be available without restriction within a month.
"What it does mean is that generic two-pill products are going to be readily available to women without age restrictions, on any drugstore shelf," Rickelman said. "It'll be like buying Tylenol. You'll be able to go get it off the drugstore shelf, no ID, at the regular counter."
Justice Department spokeswoman Allison Price said the government was reviewing the court's order.
The government has appealed U.S. District Judge Edward Korman's underlying April 5 ruling, which ordered levonorgestrel-based emergency contraceptives be made available without a prescription, over-the-counter and without point-of-sale or age restrictions.
The government asked Korman to suspend the effect of that ruling until the appeals court could decide the case, but the judge declined, saying the government's decision to restrict sales was "politically motivated, scientifically unjustified and contrary to agency precedent." He also said there was no basis to deny the request to make the drugs widely available.
The government had argued that "substantial market confusion" could result if Korman's ruling was enforced while appeals were pending, only to be later overturned.
The Food and Drug Administration was preparing in 2011 to allow over-the-counter sales of the morning-after pill with no limits when Health and Human Services Secretary Kathleen Sebelius overruled her own scientists in an unprecedented move.
The FDA announced in early May that Plan B One-Step could be sold without a prescription to those 15 and older. Its maker, Teva Women's Health, plans to begin those sales soon. Sales had previously been limited to those who were at least 17.
Korman later ridiculed the FDA changes, saying they established "nonsensical rules" that favored sales of the Plan B One-Step morning-after pill and were made "to sugarcoat" the government's appeal.
He also said they place a disproportionate burden on blacks and the poor by requiring a prescription for less expensive generic versions of the drug bought by those under age 17 and by requiring those over age 17 to show proof-of-age identification at a pharmacy.
Plan B One-Step is the newer version of emergency contraception — the same drug, but combined into one pill instead of two.
Neergaard reported from Washington.