In a strange twist of events, a federal appeals court ruled Wednesday that two-pill generic versions of the morning after pill should be immediately made available over the counter, without any age restrictions; the court, though, denied unrestricted sales of the Plan B One-Step product until it determines whether the government’s appeal should be upheld.
Last month, the federal government appealed a New York state judge’s ruling ordering emergency contraception to be made available on drugstore shelves next to condoms and tampons and without any age restrictions.
Days before the government filed its appeal, the US Food and Drug Administration announced that it would allow the Plan B One-Step product to be sold on shelves and available to anyone age 15 and over as long as they provided proof of their age to the cashier. The agency still required generic forms of emergency contraception -- in which two pills are taken 12 hours apart -- to be kept behind a pharmacy counter and dispensed only when the pharmacy is open and only to those age 17 and older.
Women’s reproductive rights activists hailed the appeals court decision.
“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,” said Nancy Northup, president of the Center for Reproductive Rights, a non-profit organization that brought a lawsuit against the FDA to force the agency to make emergency contraception available over the counter.
“The courts have said enough is enough,” said Susannah Baruch, interim president of the Reproductive Health Technologies Project. “Emergency contraception will sit on store shelves so that all women have easier access to back-up birth control when they experience a contraceptive failure.”
In deciding to take only the One-Step product out from behind the pharmacy counter, FDA officials reasoned that it would be simpler for younger teens to use a one pill version rather than to time the two pills appropriately.
The FDA had received data from One-Step manufacturer Teva showing that women age 15 and older “understood that the product was not for routine use and would not protect them against sexually transmitted diseases” and could be used safely without a doctor’s supervision.
In a ruling issued in April, US District Judge Edward Korman ruled that females of all ages be given unfettered access to the Plan B One-Step product but left it up to the FDA to decide whether to continue to restrict access to two-pill generic products.
Korman criticized the Obama administration for making an “obviously political” decision to keep teens under age 17 from purchasing Plan B One-Step without a prescription even though it’s currently “among the safest drugs sold over-the-counter.”
The FDA had decided in 2011 to lift all restrictions on emergency contraception, only to be overruled by Health and Human Services Secretary Kathleen Sebelius in an unprecidented move.Deborah Kotz can be reached at email@example.com. Follow her on Twitter @debkotz2.