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 Reproductive Health Technologies Project. “Everyone deserves a second chance to get it right, including the FDA.”