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Age restriction lifted on generic 1-pill emergency contraceptive

Consumers will soon see generic versions of Plan B One-Step on drugstore shelves that will be sold to women and girls of all ages.

The US Food and Drug Administration sent letters on Tuesday to two generic manufacturers of the one-pill form of emergency contraception, telling them that they would be allowed to sell their products over the counter without a requirement that purchasers show proof of age.

These generic products will have to be packaged with new labels, however, stating that they are not for use in girls under age 17. That means it may take a few months before they appear in stores alongside Plan B One-Step, which came out from behind the pharmacy counter last July.

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“Once a company submits its revised labeling to market a generic version of Plan B One-Step, the agency will work to approve it as soon as possible,” said Erica Jefferson, the FDA’s acting assistant commissioner for media affairs.

Teva, manufacturer of Plan B One-Step, was alerted to the change; it had been granted an exclusivity agreement by the FDA last year after conducting studies to show its product was safe to use in girls ages 15 and over. That agreement, the company hoped, would mean that generic versions of its products would be kept behind the counter for three years with age restrictions.

“The FDA has denied Teva’s request,” Jefferson said. “We determined that Teva’s interpretation of the scope of its exclusivity was too broad.”

Teva declined a request for comment.

Emergency contraception has been a tornado of controversy for the FDA for several years as women’s rights groups sued to force the agency to make it available over the counter, citing its safety profile and effectiveness at preventing pregnancies in women who have been raped or confronted with a broken condom during sex. FDA officials were ordered by a federal judge last year to make the product available over-the-counter without age restrictions. The FDA consented but only for One-Step.

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“This week’s decision means lower-cost emergency contraception will be available to women of all ages,” said Martha Walz, president of the Planned Parenthood League of Massachusetts. “More women will gain access to emergency contraception, and this should reduce the number of unintended pregnancies.”

Plan B One-Step retails for about $50, while the generic versions, Next Choice One Dose and My Way, cost $20 to $35. But the One-Step label states that it is intended for women and girls of all ages, while the generic product labels will state that they should be used only by those ages 17 and over.

“I’m very puzzled over this labeling issue,” Walz said. “I don’t know why the FDA would have any differences in labels for a generic” since it is identical to the brand name. Young teenagers might purchase the more expensive product without realizing that both are equally safe and effective.

“It’s still going to be confusing for the public,” said Dr. Susan Wood, an associate professor of health policy at George Washington University School of Public Health. Wood resigned from the FDA in 2005 after the agency refused to make Plan B available over the counter. “But it’s another step in the right direction,” she added. “The FDA has gotten itself out of this regulatory tangle.”


Deborah Kotz can be reached at dkotz@globe.com. Follow her on Twitter @debkotz2.

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Correction: An earlier version of this story stated the incorrect age range recommended on the One-Step labels.