The White House requested a $2.4 billion budget for the agency for the 2009 fiscal year starting in October, up 5.7 percent from 2008. And the Bush administration includes new funds to speed review of generics and new authority to approve biosimilars, which are also sometimes referred to as generic biologics.

Generic drugmakers have been pushing the FDA for specific guidance on developing biosimilars, an issue that has gained traction as part of the larger health care debate because existing biologics are expensive, often costing tens of thousands of dollars a year per patient.

“A pathway filled with roadblocks to access, including excessive market exclusivity provisions, is an empty promise for countless patients who need these affordable life-saving medicines,” Kathleen Jaeger, ceo of the Generic Pharmaceutical Association, says in a statement.

Drugmakers and medical device makers now pay user fees to the agency to speed review of their products. The agency, in a repeat of a request last year, is seeking fees from generic companies to do the same. Lawmakers would need to pass separate legislation to allow the FDA to charge the generic drug fees. The trade group called for Congress to increase supplemental funding for the FDA’s Office of Generic drugs. Administration officials, meanwhile, will release more details on the budget later this afternoon and the FDA is planning a briefing.

Want to read about FDA performance? Look here, and click on the chart, too. And this is the 2009 proposed budget.