Morning-after victory

6/13/2013

Reluctantly yielding to a federal court decision, the Obama Administration announced this week that it will take steps to allow a version of the so-called morning-after pill, known as Plan B One-Step, to be sold over the counter to girls and women of all ages.

They will not need a prescription, nor will they be required to show identification to obtain the emergency contraceptive. There will be no restrictions on where the drug can be sold; it will be up to the manufacturer to propose venues.

The turnabout from the administration’s previous politically motivated restrictions on the pill was hailed as a significant step forward by some advocates for women. The only lingering concern was whether the price will remain a barrier for many young people and women with limited ability to pay.

This latest stance substantially repairs the damage done when Kathleen Sebelius, the secretary of Health and Human Services, intervened in 2011 to block the U.S. Food and Drug Administration from approving the morning-after pills for all women of childbearing age. The FDA had concluded, based on the best scientific evidence, that the pills are safe and effective, and that adolescent girls can easily grasp how to use them.

But Ms. Sebelius arbitrarily ruled that girls 16 and under would need prescriptions, an act that a federal judge in New York rightly condemned as “politically motivated, scientifically unjustified, and contrary to agency precedent.” In April, the FDA approved use of Plan B One-Step in girls ages 15 and 16, but still would have required checkout clerks in drugstores to demand proof of age.

Now the administration has abandoned the legal battle and announced it will move to make Plan B One-Step, an easy-to-use version of the pill, available without restrictions. It warned that Plan B One-Step might be granted “marketing exclusivity” for a period of time.

Teva Pharmaceuticals, the manufacturer, has done important studies in adolescent girls that might entitle it to some exclusive rights. But that could delay the availability of cheaper generic versions, making price an impediment to some young women. The administration said further that it would not remove restrictions on two-pill versions of Plan B or its generic equivalents, which are a diminishing fraction of the market.

Ideally, there should be no restrictions on these remarkably safe and effective drugs that can prevent pregnancy if they are taken within 72 hours of sexual intercourse.