FDA budget seeks generic biologics, user fees

WASHINGTON (Reuters) - New funds for the Food and Drug Administration to speed review of generic pharmaceuticals and new authority to approve copycat versions of biotech drugs were proposed in President George W. Bush’s budget on Monday.

The White House requested an FDA budget of $2.4 billion for the 2009 fiscal year starting in October, a slight increase from fiscal 2008.

The proposal is part of a $3.1 trillion budget proposed by the Bush administration. The Democrat-controlled Congress will likely alter much of the plan, and lawmakers will craft their own version in the coming months.

The plan proposes new authority for the FDA to approve cheaper forms of biologic drugs. Makers of generic drugs have been pushing legislation to set a clear path for the FDA to approve cheaper copycat versions of biotech medicines.

Biotech drugs are man-made forms of human proteins that are more complex and difficult to make than traditional pharmaceuticals.

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.

Administration officials will release more details on the budget later this afternoon.

The FDA regulates products ranging from pharmaceuticals and medical devices to food and cosmetics, representing about $1 trillion, or a quarter of every dollar spent in the United States.

Reporting by Kim Dixon; editing by John Wallace