FDA’s Budget: “Maintain Momentum” or “Inadequate Resources”?

Welcome to the battle of the budget numbers.

To hear it from the Bush Administration, the president’s fiscal 2009 budget request for FDA is quite generous. The $2.4 billion request is a 5.7% increase over the previous year—a nice little boost in an otherwise tight budget environment. And it really looks good when you compare it to the 3% budget reduction the president is recommending for the Department of Health & Human Services overall.

As FDA chief operating officer Jim Dyer put it yesterday, the president’s budget request will “maintain momentum” over 2008 funding levels, allowing FDA to “target the critical areas that have been identified by the Commissioner and the Secretary.” The increase, he said, “gives us a real good start and lays the groundwork of where we need to go.”

Others would dispute that analysis. The Alliance for a Stronger FDA, which has been advocating for greater funding for the agency, notes that the Administration’s budget is an increase of just 2.9% in appropriated funding (from $1.72 billion to $1.77 billion). The balance comes from user fees paid to FDA by industry, which would increase 14.4%.

“FDA is in critical need of significant new resources,” William Hubbard, a former deputy commissioner and Alliance member said. “The amount in the Administration’s proposed budget is not only inadequate, it is barely half of what FDA needs just to keep pace with inflation.” What FDA really needs, the Alliance says, is an additional $380 million in appropriations, or seven times the Administration’s request.

The battle over funding for FDA was previewed during a House Oversight & Investigations subcommittee hearing last week. The topic was an FDA Science Board report that found the agency to be so deficient in its scientific and technological capacities that it is unable to meet its regulatory responsibilities. You can find our earlier post on that here.

And money is the biggest obstacle: while FDA has received generous raises in user fees over the years for activities like new drug reviews, other areas—like drug safety, information technology and guidance development—have largely been funded by appropriated dollars, which haven’t kept up with inflation.

Last week’s House hearing demonstrated the conundrum FDA faces. Congress loves to beat up on FDA for not asking for more money, but then doesn’t actually give the agency any more money to do its job. It’s a vicious cycle: the agency can’t do its job without more money, and it can’t get more money because it’s not doing its job. Once the dust clears, that’s an awful lot of time and money spent on getting nowhere.