While industry foots the bill to help FDA meet its drug review obligations, lack of federal funding has imperiled the agency’s ability to carry out other functions, say advocates.
“The FDA is in distress,” said Wayne Pines, president of the FDA Alliance, one of two nonprofit groups that have sprung up to draw more attention to what they see as a substantial financial shortfall.
FDA’s budget is about $1.5 billion. That doesn’t include funding from drug companies—called user fees—designed to help FDA reviewers hit their one-year deadlines on applications for new drugs. That legislation, the Prescription Drug User Fee Act (PDUFA), is being taken up by Congress this year and could result in a $392 million influx, which the agency has earmarked to fund an expanded drug safety program. That’s an increase of about $87 million from the current financial year, 2007.
But while user fees and other earmarks grow, FDA’s federal appropriations have not kept pace with costs. The FDA’s own 2008 budget request includes a $29-million increase compared to 2007: $10.6 million for food safety, $11.2 million for modernizing drug safety and $7.2 million for medical device safety and review. The agency needs much more—about $80 to $100 million more a year, or about a 5.8% increase—just to keep even with inflation, according to figures from the alliance.
Pay and benefit increases and other costs are not truly reflected in appropriation requests, said Steven Grossman, alliance executive director. In fact, the budget almost always includes reductions. Grossman, speaking at the Drug Information Association (DIA) meeting in New York City last week, said his immediate goal is to up FDA appropriations as a percentage of total costs and help reestablish head count to 2003 levels. That was the year the number of full-timers peaked at about 4,000, with roughly 500 positions added in the wake of Sept. 11.
These days the agency is more worried about retention. Had the FDA not gotten an additional $90 million this year over its base, 400 staff would have had to be laid off, Grossman said. (The financial year 2007 increase comprised $65 million from Congress and $25 million in user fees.)
The second group taking up the funding cause, the Coalition for a Stronger FDA—which counts three former HHS secretaries as members—wants an ambitious $175 million increase: $115 million for food safety, $40 million for drug reviews and $20 million for medical device programs.
“We are concerned that Congress is continually increasing the responsibilities of FDA, without correspondingly increasing the appropriations,” Bill Hubbard, a senior adviser to the coalition, said in a statement.
Indeed, there’s no shortage of compelling needs at the agency. One of those is Critical Path, the agency’s landmark effort to integrate emerging science into the regulatory process while ensuring that approval of new therapies or devices is not hampered.
Some will come from users fees, but Congress has given the process only $6 million, Grossman said. Europe is investing $440 million a year in its own effort to overhaul drug approval.
Congress has added many other responsibilities to FDA over the years—at least 60 since 1994, by Grossman’s count. Still other imminent demands include a rise in uninspected food imports, foodborne disease outbreaks and the threat of food bioterrorism—trends that only sharpen the need for adequate funding. The alliance calls for inflationary increases each year, budgeted program increases at the same rate in future years and no annual budget cuts. While some members of Congress are listening, the alliance anticipates a hard fight.
It’s a battle important enough to inspire multiple advocates. Said Grossman: “The entirety of the agency is what’s at stake.”