FDA lowers age limit to 15 for over-the-counter birth control

McClatchy NewspapersApril 30, 2013 

Morning After Pill

Plan B One-Step (levonorgestrel) tablet from Teva Women's Health


— The U.S. Food and Drug Administration on Tuesday approved the sale of the emergency contraceptive Plan B One-Step for sale without a prescription to women ages 15 and over.

Designed to reduce the risk of pregnancy after unprotected sex, Plan B One-Step, made by Teva Women’s Health of North Wales, Pa., is most effective if taken right after or within three days after unprotected sexual intercourse, according to the FDA

The move takes the product out from behind the counter where it has been and lowers the minimum age for purchasers by two years, from 17 to 15.

The product’s label will read "not for sale to those under 15 years of age.” It also will say that proof of age is required and that it is “not for sale where age cannot be verified."

Teva also will place a security tag on product cartons to prevent theft.

The product, known as a "morning-after pill," will be available in stores with onsite pharmacies in the family planning and female health sections. It will be available for sale whether the pharmacy counter is open or not.

“Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” said FDA Commissioner Margaret A. Hamburg, a physician. “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.”

Company data also showed that Plan B One-Step could be used properly by women ages 15 and older without input from a health care provider.

Planned Parenthood Federation of America president Cecile Richards called the action "an important step forward" in making the product more widely available.

"This decision will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception when they need it, which means many more women will be able to prevent unintended pregnancy," Richards said.

One of three emergency contraceptives on the market, Plan B One-Step is a single-dose version of the more-familiar, two-dose Plan B. Both contain the active ingredient levonorgestrel.

Earlier this month, a federal judge in New York ordered the FDA to allow over-the-counter access to Plan B for women of all ages and/or allow the sale of Plan B One-Step without age or sale restrictions. But Teva’s request to market Plan B One-Step to women ages 15 and older was already pending with the FDA before the court ruling.

The decision on Plan B One-Step was independent of that litigation, which is under review by the U.S. Department of Justice.

Email: tpugh@mcclatchydc.com; Twitter: @TonyPughDC

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