Barr Laboratories, the manufacturer of the pill, has been working for three years to sell the pill to at least some women without a prescription. The FDA contacted Barr early Monday and said it wanted to meet with the company within seven days to iron out details.
The pill, called Plan B, is intended to be used as an emergency contraceptive. It is a high dose of regular birth control that can reduce the risk of pregnancy by up to 89 percent if taken within 72 hours of unprotected sex.
The FDA's scientists say the pills are safe and contraceptive advocates and doctors groups say easier access to a to a morning-after birth control pill could cut the nation's 3 million annual unintended pregnancies in half.
The FDA had previously rejected the sale of Plan B, citing concern about young teens' use of the pills without a doctor's supervision. Barr reapplied, asking that women age 16 and older be allowed to purchase the pill if it could set up a program for pharmacists to enforce the age rule.
Last August, FDA's then-chief postponed a decision indefinitely, saying the agency needed to determine how to enforce the age restrictions, which would require writing new regulations.
On Monday, the FDA said Barr needs to make some changes to before it can re-file its application:
-Barr must agree to sell the non-prescription pill only to women aged 18 and older, not 16 as the company had initially proposed.
-Both the nonprescription and prescription versions of the pill would be kept behind the pharmacists' counter and Barr must sell the nonprescription version in completely different packaging to make sure that people can tell them apart.
-Barr must give details on how it will enforce the age restriction. The FDA warned that Plan B will remain in its prescription-only form if rules of sale are not strict enough.
