February 17, 2006

A bipartisan group of House lawmakers used a Feb. 16 hearing on the FDA's fiscal 2007 budget as an opportunity to blast the agency's top official on several fronts, including delays in approving the Plan B emergency contraceptive and a growing backlog of generic drug reviews.

Democrats and Republicans on the House Agriculture Appropriations subcommittee, which has jurisdiction over the FDA's budget, demanded answers from the agency on these and other topics. But acting FDA Commissioner Andrew von Eschenbach declined to set firm deadlines for addressing many of the concerns.

Democrats, including Reps. Rosa DeLauro (D-Conn.) and Sam Farr (D-Calif.), repeated earlier criticisms of the agency on Plan B, including that it has delayed OTC approval of the drug for purely political reasons. The agency's handling of Plan B represents "real stonewalling," said Farr, adding "There is quite a bit of politics going on."

But Eschenbach denied politics played a role in delaying approval of the drug, and instead cited the ongoing analysis of public comments along with the complexity of the issue. Barr Laboratories first sought OTC status for Plan B (levonorgestrel) in 2003.

Meanwhile, Republicans, including Reps. Virgil Goode (R-Va.) and Jo Ann Emerson (R-Mo.), joined Democrats in arguing that the FDA has dedicated insufficient funds to increase generic drug access. The proposed fiscal 2007 funding for the Office of Generic Drugs (OGD) is nearly flat at $29.1 million, compared to $28.3 million in 2006. The flat funding comes as OGD faces a backlog of generic drug applications. The OGD estimates the average review time for abbreviated new drug applications will increase to 17.5 months this year, up from 16.9 months in 2006 and 16.3 months in 2005.

The agency has a number of solutions to address the backlog, Eschenbach said, including a more concise application process, use of an electronic system for applications and internal improvements in agency procedures. The agency also is considering new user fees for generic drug manufacturers to lessen these delays, OGD officials added.