FDA lifts age restrictions on OTC Plan B morning-after contraceptive

FDA is allowing generic sales of emergency contraceptives to be sold over the counter, without age restrictions, NPR has reported.

Last summer, FDA lifted Plan B One-Step restrictions. In approving Plan B One-Step, FDA also granted Teva, the contraceptive’s manufacturer, an addition three years of protection from generic competition because it conducted an additional market study on the product's use by teens.

It appears that the FDA has now reconsidered. In an 11-page letter to those generic competitors sent earlier this week, Kathleen Uhl, acting director of 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."

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.

“The availability of this product for patients in need is very important,” said Michelle Hilaire, clinical pharmacist at the Fort Collins Family Medicine Residency Program, Fort Collins, Colo. “Not all females live in an area that has timely access to a healthcare provider for prescription access, and sometimes a pharmacy is the only option available. One of the most important things with this change is making sure providers and pharmacists are giving patients correct information about the age changes. Patients shouldn’t be denied this product due to misinformation.”