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FDA To Increase Access To Generic Morning-After Pills

Women's health groups campaigned hard to make a generic — and often cheaper — emergency contraceptive pill more widely available.
Elise Amendola
/
AP
Women's health groups campaigned hard to make a generic — and often cheaper — emergency contraceptive pill more widely available.

The Food and Drug Administration has decided to allow generic versions of the most popular form of emergency contraceptive pills to be sold over the counter, without age restrictions, after all.

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.

Women's health groups were generally pleased with the action. "This is a significant leap forward in obtaining full, over-the-counter status for emergency contraception and we commend the FDA for this decision," said Jessica Arons, president and CEO of the . "Everyone deserves a second chance to get it right, including the FDA."

Copyright 2020 NPR. To see more, visit https://www.npr.org.

Julie Rovner is a health policy correspondent for NPR specializing in the politics of health care.Reporting on all aspects of health policy and politics, Rovner covers the White House, Capitol Hill, the Department of Health and Human Services in addition to issues around the country. She served as NPR's lead correspondent covering the passage and implementation of the 2010 health overhaul bill, the Patient Protection and Affordable Care Act.