A major announcement from the FDA regarding morning-after pills.
The Food and Drug Administration is set to announce that generic versions of the most popular form of emergency contraceptive pills will be sold over the counter without age restrictions.
The popular morning-after pill Plan B were approved for sale without a prescription in 2006, for women 17 and older. Generic versions became available over the counter in 2009, with the same age restrictions. In July, 2013, the FDA removed the age restrictions on Plan B, but less expensive generic versions still required a prescription for consumers younger than 17.
Originally, when the FDA removed the age limits on Plan B, it said it would let Teva Pharmaceuticals dominate the market because it had conducted an additional market study on the product’s use by teenagers. At the time, women’s health groups, who have campaigned hard to make the product more widely available, were disappointed in the decision because Plan B One-Step is considerably more expensive than its generic competition, making it less affordable for many women.
The FDA announced its decision to approve generic versions to anyone of any age, off the shelf without a prescription, in an 11-page letter to manufacturers of the generic product.
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 Technology Project.
The morning-after contraceptives prevent most pregnancies if taken within 72 hours of unprotected sex for women who weigh less than 165 pounds. The pills work by delaying or inhibiting ovulation.