Barr Laboratories had cause for celebration yesterday after Health Canada said that the firm’s Plan B (levonorgestrel) emergency contraceptive would be available without a prescription, with immediate effect.
However, the question remains whether the US Food and Drug Administration will follow its neighbour’s lead and give the nod to OTC Plan B as well. Whether to approve the product has become a thorn in the FDA’s side. A decision had been expected by the end of January, and the agency’s silence has prompted outrage from US senators, Patty Murray and Hillary Clinton, who have vowed to delay voting on President Bush’s nomination of Lester Crawford as the new FDA chief until a decision is made [[14/04/05c]], [[08/04/05b]]. Barr filed Plan B with the US regulator last summer after the agency controversially knocked back an initial application, saying that the firm had not provided adequate data to suggest the product could be used safely by young adolescent women [[23/07/04b]].
“We are pleased that Canadian regulatory authorities have recognized that Plan B is safe and effective for use by women as emergency contraceptive and will make it available without a prescription,” said Bruce Downey, Barr’s chairman and chief executive. “We look forward to a decision on this critical health issue by the US Food and Drug Administration.”
Plan B, which will be marketed and distributed by Paladin Labs, has been shown to reduce the risk of pregnancy by 89% if taken within 72 hours of unprotected sex. It is most effective when taken within the first 24 hours, with efficacy declining as the interval between intercourse and treatment increases. Barr explains that this decline in efficacy is why a broad range of health professionals believe that barriers to more timely access to Plan B should be removed, including making the product broadly available without prescription. “Women who need this product must have access to it very quickly or it will not be effective,” said Canadian Health Minister, Ujjal Dosanjh. “Allowing the product to be sold without a prescription will ensure that it is available when needed.”