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WASHINGTON (AFX) - The maker of the morning-after pill said it received assurances Tuesday that the government would quickly settle a three-year battle to sell the emergency contraceptive without a prescription to at least some women.
Last week, the Food and Drug Administration stunned Barr Pharmaceuticals Inc. by announcing that its long-delayed attempt was back on the table -- with some caveats. FDA said it would consider nonprescription sales of the pill called Plan B only for women 18 and older, and demanded details on how Barr would ensure that pharmacies enforced that age restriction.
After meeting with FDA officials Tuesday, Barr said it would amend its Plan B application within two weeks.
"They made it clear to us they intend to act quickly," said Barr spokeswoman Carol Cox, who called the meeting "very productive."
Of the newest age restriction, she said only: "These are all issues we can work through."
FDA officials didn't immediately comment.
The morning-after pill is a high dose of regular birth control that, taken within 72 hours of unprotected sex, can lower the risk of pregnancy by up to 89 percent.
Contraceptive advocates and doctors groups say easier access to the prescription-only pill could halve the nation's 3 million annual unintended pregnancies, and FDA's own scientists call the pills safe. In December 2003, the agency's independent scientific advisers overwhelmingly backed nonprescription sales for all ages.
But FDA rejected that recommendation, citing concern about young teens' use of the pills without a doctor's guidance. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription. Last August, FDA postponed a decision indefinitely, calling for new regulations on how to enforce age restrictions.
Then last week, FDA said new regulations weren't needed after all, and that it would reconsider Barr's application with an age restriction of 18 -- to conform with age checks that pharmacies already perform for tobacco sales -- and a few other steps. Copyright 2006 Associated Press. All rights reserved. This material may not be
Copyright 2006 AFX News Limited. All Rights Reserved.
