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Court orders FDA to make some Plan B pills available to all

An appeals court ordered the U.S. Food and Drug Administration on Wednesday to make certain forms of "morning-after” birth control pills available freely over the counter to anyone who wants to buy them.

But the court said the FDA could continue to restrict access to a newer, one-pill formulation called Plan B One-Step while the agency appeals a lower court ruling.

The ruling from the 2nd Circuit Court of Appeals instructs the FDA to make available two-pill versions of emergency contraception drugs that contain levonorgestrel. It does little to clear up confusion over who can buy what product and where, but it’s a step toward forcing the FDA to follow its own medical guidance on the matter -- which is to make all emergency contraception available over the counter, without a prescription and without proof of age, to anyone who wants to buy it.

An FDA spokeswoman says the agency is considering its response.

“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,” Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a statement.

Federal judgeEdward Korman has ordered FDA to make both types of birth control freely available. While the fight was going on, FDA gave an amended approval to one brand, Teva’s Plan B One-Step, saying it could be sold to any girl or woman 15 or older with ID and in stores with on-site pharmacies.

Korman, clearly furious, accused the FDA of being politically motivated and said it made a “sweetheart deal” with Teva. The FDA has appealed the ruling and the three appeals court judges -- Ralph Winter, Peter Hall, and Gerard Lynch -- have now given the FDA a little bit more time to appeal the decision on Plan B One-Step. But the court says FDA has to comply with Korman’s order to make the older, two-step formulations available to all comers right away.

“Insofar as the order mandates immediate over-the-counter access to the two-pill variants of emergency contraceptives, a stay is denied because the Appellants have failed to meet the requisite standard,” they wrote.

In 2011, the FDA approved emergency contraception, also known as the "morning-after" pill or "Plan B", for women of all ages. But the administration stepped in immediately and said only women 17 and older could buy the pills without a prescription.

Health and Human Services Secretary Kathleen Sebelius said at the time she didn’t want girls “as young as 11” buying contraceptives on their own.

Women’s health groups filed suit and on April 5, Korman ordered the FDA to lift age restrictions on all levonorgestrel-based emergency contraception.

“I did so because the Secretary’s action was politically motivated, scientifically unjustified, and contrary to agency precedent,” Korman wrote.

The single pill formulation contains a high dose of the same hormone used in birth control pills to prevent or delay ovulation, prevent fertilization or, in some cases, prevent implantation of a fertilized egg in the uterus. Plan B One-Step will not end a pregnancy if a woman is already pregnant and there is no medical evidence it harms a developing fetus, FDA officials have said.

Plan B, available from generic manufacturers, uses two doses of levonorgestrel. Another emergency contraceptive, ella, or ulipristal, is a prescription-only product that prevents pregnancy when taken within five days of unprotected intercourse.

The FDA has said that all the drugs are extraordinarily safe. Women’s health groups note that girls of all ages can buy far more dangerous products over the counter now, from aspirin to cold medicines, and that they also have access to condoms without a prescription or parental permission.