Barr Laboratories is planning to lobby state officials to enable some women to have access to its over-the-counter emergency contraceptive, Plan B (levonorgestrel), should the Food and Drug Administration dismiss the firm’s second bid to sell the product without a prescription in the USA.
According to a Reuters report, the company will lobby states individually in a bid to extend its collaborative programme, under which pharmacists in Alaska, California, Hawaii, Maine, New Mexico and Washington are already able to write prescriptions for Plan B either after completing a special course, or by working with a doctor.
However, it remains to be seen when the FDA will ultimately make a decision on whether to approve Plan B. The agency had been expected to make a ruling by the end of January after going against the recommendation of its advisory board and rejecting Barr’s original application last year [[07/05/04b]], [[17/12/03a]]. The decision prompted accusations that the Bush Administration – which has implemented a more restrictive policy on issues such as abortion since coming to power – has exerted pressure on the FDA to delay or even quash the application. Barr refiled Plan B, which has been shown to reduce the risk of pregnancy by almost 90% when taken within 72 hours of unprotected intercourse, last July, but excluded its use in girls aged under 16 [[23/07/04b]].
And, because there has been no word from the FDA, the nomination of Lester Crawford as the agency’s new chief has faced a setback – US senators, Patty Murray and Hillary Clinton, succeeded in delaying a vote on the nomination until a decision on Plan B materialises [[14/04/05c]], [[15/02/05a]].
- Meanwhile, The inspector general at the US Department of Health and Human Services could be set to launch a probe into whether Dr Crawford conducted an “inappropriate personal relationship with a senior agency colleague”, after allegations were made in an anonymous letter sent to the US Senate Health, Education, Labour and Pensions Committee, according to the Washington Post.