Like many organizations, the Food and Drug Administration (FDA) will have a relatively flat budget if President Barack Obama has his way, with one notable exception. Although the amount provided to the FDA by the government will not change significantly, the administration expects a boost in the so-called "user fees" money provided by the companies whose products are approved and supervised by the FDA. These fees are an important part and growing, the FDA budget. In the draft 2013 budget, the costs would increase to $ 1.97 billion, from $ 1.33 billion in 2012, whereas the amount provided by the Administration would hold steady at $ 2.5 billion. This would bring the percentage of the FDA's budget comes from 44% usage fee.
Although these costs have become essential to maintaining FDA running, he was concerned about the years that fees put FDA in a difficult position: It makes money from the same companies whose products it approves. "The agency has become dependent for funding on the very industry over which it has regulatory authority," wrote Public Citizen, an advocacy group, in a letter to Congress in 07. At that time, about 20% of the budget the agency came from user fees.
another concern is that although more user fees give FDA what looks like a fiscal boost, they do not come with the same flexibility. "We are more concerned about the affected dollars" -the money that comes directly from the government, not businesses, said Steven Grossman, deputy executive director of the Alliance for a stronger FDA, a nonprofit group Silver Spring, Maryland, that lobbies for funding additional FDA. "User fees pay for very specific services, and they are truly additive to what the FDA is responsible and what the FDA is responsible for the execution."
In response to a press conference this afternoon to a question on the piece ever increasing budget of his agency uses these costs, FDA Commissioner Margaret Hamburg defended. "It is not appropriate that industry help share and support these critical services that rely heavily," she said. "In these difficult economic times, it becomes even more crucial that we take advantage of resources." most new user fee funds come from new fees for the review of generic drugs and 'biosimilars', designed to be generic versions of biologic drugs.
in general, the budget request for FDA stresses many of the same programs he has emphasized in recent years, including the construction of a stronger food safety net. the FDA has also directed the money to improve science regulatory, research that will help the organization improve the way it evaluates new treatments. in 2013, the FDA said it plans to "support" its scientific program of regulation against medical measures, but no one knows if not the program will get increased funds.
"A flat budget will slow this process down, there's no question about it," says Grossman.
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