The US food and Drug Administration has missed the deadline to deliver a verdict on Barr Laboratories’ license application for Plan B (levonorgestrel), an emergency contraceptive, leading to claims that the agency is allowing political issues to affect the review process.
The issue emerged during a hearing convened by the US Senate Health, Education, Labour and Pensions Committee as part of the process of vetting acting FDA commissioner Lester Crawford as he seeks to make the job permanent. Crawford has been acting FDA commissioner for nearly a year, and faced probing questions from Senate Democrats over the agency’s handling of Plan B. He is President George Bush’s nomination for the post [[15/02/05a]].
Plan B is already available in the US as a prescription drug, but Barr has been trying to launch it as an over-the-counter product. Under its Prescription Drug User Fee Act obligations, the FDA was committed to delivering a verdict on the application in January, but Crawford said at the hearing that a decision is still weeks away, according to Reuters reports. If successful, Plan B would be the first morning-after pill to be available OTC in the US.
But the marketing application for Plan B has already proved controversial. On the one hand, family planning organisations believe that the availability of an OTC emergency contraceptive would be a powerful new weapon against unplanned pregnancies, as it can be used to prevent pregnancy if taken within 72 hours of unprotected sex. On the other, conservative groups, such as Concerned Women for America, have suggested that making it more freely available would lead to promiscuity and a rise in sexually-transmitted diseases.
Last year, the FDA courted the controversy by over-ruling a recommendation to approve the drug delivered by its own advisory committee, saying that the company needed to prove that Plan B was safe for use in younger girls aged 11 to 16 [[07/05/04b]]. 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. The overruling also prompted calls for Crawford’s resignation as the acting head of the FDA [[27/07/04b]].
Barr elected to refile its application, excluding use of Plan B in girls under 16, in the wake of the FDA’s “not approvable” judgement, and it is this application that is currently under review at the agency.
