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FDA expands over-the-counter access to generic emergency contraception

Generic brand alternatives to Plan B One-Step will now be sold over the counter without age restrictions

Katie McDonough
March 3, 2014 11:16PM (UTC)

The Food and Drug Administration has announced that generic brands of emergency contraception will now be sold over the counter without age restrictions.

This is good news, as generic alternatives to Plan B One-Step are less expensive but equally effective.


More from NPR:

Last July, after a decade-long battle and under court order, the FDA removed the age restriction on sales of Plan B One-Step, which can prevent most pregnancies if taken within 72 hours of unprotected sex for women who weigh less than 165 pounds.

But in approving the product for sale without prescription, the FDA also granted Teva Pharmaceuticals, the drug's maker, an additional three years of protection from generic competition because it conducted an additional market study on the product's use by teenagers.

Women's health groups who had campaigned hard to make the product more widely available were disappointed in that decision because Plan B One-Step is considerably more expensive than its generic competition — often by at least $10.

But now the FDA has reconsidered. In an 11-page letter to those generic competitors sent earlier this week, Kathleen Uhl, acting director of the FDA's Office of Generic Drugs, wrote that Teva's contention that competitors should not be allowed to sell their products over the counter without age restrictions "is too broad."

In something of a compromise, the FDA now says the generic versions of the product must still say on their labels that they are intended for "women 17 years of age or older," but they may be sold directly from retail shelves without a requirement to produce proof of age.

Katie McDonough

Katie McDonough is Salon's politics writer, focusing on gender, sexuality and reproductive justice. Follow her on Twitter @kmcdonovgh or email her at kmcdonough@salon.com.

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Birth Control Emergency Contraception Plan B One-step

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