Less than a month after a federal judge ordered the Food and Drug Administration to make emergency contraception available over-the-counter without any age restrictions, the agency said that it would allow one product to be offered on drugstore shelves — but only to those age 15 and over.
The agency said Plan B One-Step could be sold on shelves next to other family planning products such as condoms and pregnancy tests. Consumers will be required to show proof of age at the register.
Emergency contraception contains high doses of the female hormone progestin and needs to be taken within three days of unprotected sex to prevent pregnancy; it’s currently available without a prescription to those age 17 and over but is kept behind a pharmacy counter and dispensed only when the pharmacy is open.
The decision is “not intended to address the judge’s ruling,” the FDA said in a statement, but was in response to an application filed by Teva, the manufacturer of Plan B One-Step, before reproductive rights organizations filed the lawsuit that led to the New York judge’s ruling on April 5.
The judge gave the FDA 30 days to comply. The Department of Justice has until the end of this week to appeal the decision and is “still considering next steps in the litigation,” according to the FDA.
The FDA’s decision does not apply to generic versions that require women to take two pills, 12 hours apart — these will remain stocked in the pharmacy.
“Today, we welcome the FDA’s decision to provide extended and improved access to this important product, a significant milestone for women,” said Teva vice president Marty Berndt.
Women’s health advocates who initially cheered the judge’s ruling had a tepid response to the FDA’s decision. Senator Patty Murray called it a “step in the right direction for increased access,” adding that she would continue to push the FDA on the “practical application of this policy.”
For example, teens will be required to show identification verifying their age to the cashier when purchasing the One-Step product, and many of those under age 17 may not have a photo ID if they do not yet have a driver’s license.
“It’s a strange decision,” said Dr. Susan Wood, an associate professor of health policy at George Washington University School of Public Health. She resigned from the FDA in 2005 after the agency initially dragged its feet on allowing Plan B to be sold over-the-counter for adult women. “It offers improved access to some women with IDs but not to high school students, and it clearly isn’t what the judge directed,” she said.
The court case stemmed from the Obama administration’s decision to overrule the FDA in 2011, when it decided to allow the One-Step product to be available over-the-counter without age restrictions. After that, Teva amended its application in a compromise, seeking to have its product approved for use in girls age 15 and over.
The FDA said Teva submitted study data 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.
Nancy Northup, president of the Center for Reproductive Rights, one of the plaintiffs in the lawsuit against the FDA, said it would “continue its battle in court” to remove “arbitrary restrictions on emergency contraception for all women.”Deborah Kotz can be reached at email@example.com. Follow her on Twitter @debkotz2.