FDA expands over the counter access to generic emergency contraception
by JULIE ROVNER
March 02, 2014 7:30 AM
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.
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http://www.npr.org/blogs/health/2014/03/02/284397995/fda-to-increase-access-to-generic-morning-after-pills