This move comes just weeks after a federal judge in Brooklyn, New York, ordered the FDA to make the morning-after birth control pill available to women of any age, without a prescription. Tuesday's FDA announcement, which pertains to an application from Teva Women's Health, Inc., is not related to that, the FDA said.
"The FDA's approval of Teva's current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge's ruling," the FDA said in a statement.
In early April, the U.S. Justice Department indicated an appeal of the Brooklyn judge's order was under consideration. "The Department of Justice is reviewing the appellate options and expects to act promptly," department spokeswoman Allison Price said.
According to the new FDA decision, Plan B One-Step will now be labeled to reflect that proof of age is required to purchase it, and it cannot be sold where age cannot be verified. The packaging will include a product code that prompts the cashier to ask and verify the age of the customer.
The product will be available in retail outlets with pharmacies, but the pill can be sold during non-pharmacy hours, too.
"While we fully support this expansion of access to birth control, we continue to believe that the administration should lift all unnecessary restrictions to emergency contraception, consistent with the prevailing science and medicine," Planned Parenthood Federation of America President Cecile Richards said Tuesday in a statement.
The FDA decision does not pertain to the two other emergency contraceptive drugs marketed in the United States. Plan B is available from generic manufacturers over-the-counter for women 17 and older and Ella is available by prescription only, for all ages, and prevents pregnancy within five days of unprotected sex or contraceptive failure.