Issue Date: May 25, 2009
FDA Gets Funding Boost for 2010
PRESIDENT BARACK OBAMA has proposed increasing the Food & Drug Administration's 2010 budget by $511 million, or 19%, compared with 2009—the largest increase ever requested by a president for the agency. The increase includes $295 million in allocated money and $215 million in industry user fees, bringing FDA's total budget to $3.2 billion.
FDA is in dire need of the additional money, observers say. The agency has recently had to deal with the biggest Salmonella outbreak in decades, pet food contaminated with melamine, adulterated heparin blood-thinning drugs, and many other scientific challenges—all with limited resources.
The additional funds will be used to support priority areas such as food safety, safer drugs and medical products, the approval of generic biological drugs, and the development of drug importation policies.
Although the new money will be spread throughout all FDA programs, food safety efforts will receive about half of the increase, or $259 million.
FDA's budget has dwindled or remained flat since the mid-1990s, and since then its food program has taken the biggest hit. "Food safety probably deserves the biggest increase because its needs are the greatest," William K. Hubbard, former senior associate commissioner of FDA, tells C&EN.
In the area of food safety, money will be invested in various categories across FDA to strengthen the safety and security of the food supply chain, focusing on both foreign and domestic sources. The initiative will rely on risk-based prevention, holding all segments of industry accountable for meeting safety standards.
The President's 2010 budget also includes $75 million in new user fees to register and inspect food facilities, as well as $19 million for export certificates and reinspection of food facilities that fail inspections.
But observers like Hubbard discount the inclusion of new user fees saying they are not real money. The fees have to be authorized by Congress—something Hubbard predicts won't happen anytime soon. Such fees have been requested in the past and not authorized, he notes.
THE 2010 BUDGET provides $166 million for efforts to strengthen the safety of drugs and medical devices, including $36 million in new user fees for generic drug review and nearly $11 million in new fees to reinspect facilities that don't meet safety standards. The budget also proposes new authority for FDA to approve generic biologics—generic versions of drugs made by living cells—and $5 million for the agency to develop policies for allowing drug imports.
The generic drug industry "remains open to a generic user fee program so long as there are guarantees that the fees would result in the timely review and approval of generic applications," Kathleen Jaeger, president and chief executive officer of the Generic Pharmaceutical Association, said in a statement. In terms of generic biologics, she called the President's proposal a "workable scientific, regulatory, and legal approval pathway."
The 2010 budget is a good start, but more increases are needed, some observers say. "It's a good budget; it's an actual increase as opposed to the Bush years," Hubbard notes. "Even after inflation, FDA will end up with close to $200 million in actual new money—funds to hire new people, to do new things, to solve problems."
But "the bottom line is that this budget brings FDA back to about where it was in 1994," in terms of staffing levels, Hubbard says. "Hopefully, future increases will be provided that can allow the agency to actually move forward and solve some of the most pressing problems, such as food safety, imports, and drug postmarket surveillance."
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