US FDA budget seeks biotech generics, user fees

People are starting to talk about the impact of the political system on the FDA...

Not good to see this function impacted by politics...


WASHINGTON, Feb 4 (Reuters) - New fees for the Food and Drug Administration to speed review of generic pharmaceuticals and new authority to approve copycat versions of some 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 5.7 percent increase over last year's budget.

The proposal comes as the FDA faces heightened criticism for inadequate staffing, lax oversight of drug and food safety and out-of-date technology. Last week, lawmakers met to discuss a report by an independent board that concluded lives are at risk because the agency is so underfunded and behind in cutting edge science.

"It's pretty disappointing, especially in light of the overall unanimity of concern over food safety and drug safety," said Bill Hubbard, an advisor to the Alliance for a Stronger FDA, and former associate FDA commissioner from the early 1990s through 2005. The Alliance is made up of industry, and consumers and patient groups.

Hubbard said that because FDA's costs are more aligned with medical costs, which are rising faster than overall consumer inflation, "it's barely half of what FDA needs just to keep pace with inflation."


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