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27 November 2013 12:59 pm ,
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- 27 November 2013 12:59 pm , Vol. 342 , #6162
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FDA Stays the Course, But Asks Firms to Kick In More Fees
13 February 2012 4:31 pm
Like many agencies, the U.S. Food and Drug Administration (FDA) will have a relatively flat budget if President Barack Obama has his way, with one notable exception. While the amount provided to FDA by the government won't change meaningfully, the Administration is planning for a boost in what are called "user fees," money provided by companies whose products are approved and overseen by FDA. Those fees provide a sizable, and ever-increasing, portion of FDA's budget. In the 2013 budget proposal, the fees would increase to $1.97 billion, from $1.33 billion in 2012, while the amount provided by the Administration would hold steady at $2.5 billion. This would bring the percentage of FDA's budget that comes from user fees to 44%.
While such fees have now become critical to keeping FDA running, there has been concern over the years that the fees put FDA in a difficult position: It's getting money from the same companies whose products it approves. "The agency has become dependent for its funding upon the very industry over which it has regulatory authority," wrote Public Citizen, an advocacy group, in a letter to Congress back in 2007. At that time, about 20% of the agency's budget came from user fees.
Another concern is that even though more user fees give FDA what looks like a budget boost, they don't come with the same flexibility. "We're most concerned about the appropriated dollars"—the money that comes directly from the government, not from companies, says Steven Grossman, deputy executive director of Alliance for a Stronger FDA, a nonprofit group in Silver Spring, Maryland, that lobbies for additional FDA funding. "The user fees pay for very specific services, and they are really additive to what the FDA is responsible for and what the FDA is responsible for accomplishing."
Responding at a press conference this afternoon to a question about the ever-growing chunk of her agency's budget that draws on these fees, FDA Commissioner Margaret Hamburg defended them. "It's not inappropriate that industry help share and support these critical services that matter so much," she said. "In these difficult economic times, it becomes even more crucial that we leverage resources." Many of the new user fee funds would come from new fees for generic drug reviews and "biosimilars," which aim to be generic versions of biologic drugs.
In general, the budget request for FDA stresses many of the same programs it has focused on in recent years, including building a stronger food safety net. The FDA has also directed money toward improving regulatory science, research that will help the agency improve how it assesses new treatments. In 2013, FDA says it plans to "sustain" its regulatory science program in medical countermeasures, but it's not clear whether the program will get any increase in funds.
"A flat budget will slow that process down, there's no question about it," says Grossman.