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FDA lowers age for over-the-counter access to morning-after pill

The controversial emergency contraceptive Plan B One-Step will be made available without a doctor’s prescription to girls aged 15 and 16, the US Food and Drug Administration (FDA) announced yesterday. The agency also said it would move the pill (levonorgestrel) from behind pharmacy counters to the shelves. That also means that older women will no longer need to find stores where a pharmacist is on duty to obtain the pill, which becomes less effective the longer after sexual intercourse it is taken. Under the new rules, girls under 15 will still need a doctor’s prescription and older women will still need to show proof of age.

The FDA decision comes days before a deadline for the administration of US President Barack Obama to appeal a ruling on Plan B One-Step issued by a New York judge last month.  In his 4 April opinion, Judge Edward Korman of the eastern district of New York required the agency to make the pill available without restriction to women of all ages within 30 days. He called a 2011 decision by Obama’s secretary of health and human services, Kathleen Sebelius, to overrule the FDA and deny over-the-counter access to girls under 17 years old “politically motivated, scientifically unjustified and contrary to agency precedent”. Nature has opined about the Plan B issue here and here.

Obama’s Department of Justice would not comment yesterday on whether it intends to appeal.  The FDA said that yesterday’s decision responded not to the judge’s ruling, but to an application by Plan B One-Step’s manufacturer, Teva Women’s Health, to make the pill available over the counter to females aged 15 and older. The agency’s announcement states that the decision  is “based on an actual use study and label comprehension data submitted by Teva” that showed that the pill could be used properly by girls aged 15 and 16 without a doctor’s help.

Margaret Hamburg, the FDA commissioner said: “The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease.”


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