FDA budget draws cries of ‘not enough’

The Food and Drug Administration was sitting pretty last week, winning a significant budget increase while many other federal agencies faced the prospect of cut or frozen funding as the Obama administration confronts a 13-figure deficit.

But a coalition of public interest advocates, patient groups and healthcare industry interests regulated by the FDA had a swift response: It’s not enough.

“We are disappointed in the president’s budget request and . . . will seek to increase” the budget, said Steven Grossman, deputy executive director of Alliance for a Stronger FDA. The group lists seven former FDA commissioners and many of the largest and most influential consumer, food and pharmaceutical trade groups among its 180 members.

The group traces its efforts to increase FDA funding back about five years; in that time the agency’s budget has more than doubled, to a proposed $4 billion for 2011 from $1.86 billion in 2006.


Lobbying for more money for a regulatory agency in the face of a projected trillion-dollar deficit may seem counterintuitive, especially when many of those doing the pushing include business interests that have not always welcomed FDA oversight.

“The regulated want to starve the regulator. That’s Economics 101,” Grossman acknowledged. “But the FDA is different.”

That’s because the FDA’s role in ensuring the safety of food, drugs and medical devices influences everything from the price of produce to the marketability of high-tech medical goods, said Grossman, a healthcare consultant and lobbyist.

“If there’s a problem, or a perception of a problem, everybody suffers -- not just the company with the problem,” he said.

Caroline Smith DeWaal, director of food safety for the Center for Science in the Public Interest, said that although the center and other groups in the alliance “generally worked on opposite sides of the issue” from the food and drug industries, both sides were alarmed by “mission failure” at the FDA resulting from chronic underfunding.

Any one of a number of high-profile food recalls in recent years cost businesses more than $100 million, Smith DeWaal said. “If that $100 million went into the FDA budget, it could prevent five recalls, or maybe 10 recalls,” she said.

What troubles the alliance isn’t so much the size of the FDA budget but the shrinking percentage of it that comes from tax coffers.

The fastest-growing part of the budget comes from user fees, paid by businesses that need an FDA service, such as drug companies seeking pre-market approval of products.


Those user fees have mushroomed from $369 million in 2006 to a budgeted $1.5 billion for 2011.

All told, the administration is seeking a 23% budget increase for the FDA.

But 80% of that would come from fees, including proposed new fees to be paid by food producers and generic drug makers.

The part of the budget that comes from tax money is slated to increase 6%, which the alliance dismisses as “a simple inflation increase.” That may not be how Congress sees it, however.


Rep. Rosa DeLauro (D-Conn.), chairwoman of the appropriations subcommittee that oversees the FDA and a staunch advocate for more funding for the agency, said in a statement that considering how bleak the federal government’s finances are, the 6% increase is “reassuring.”

Smith DeWaal, for one, is optimistic that Congress will heed the alliance’s message that funding the FDA is a confidence-builder for consumers as well as businesses.