Biosimilar fees plug FDA deficit

The US Food and Drug Administration (FDA) expects industry fees for biosimilars and other generic drugs to pay for the agency's substantial increase in spending. This February, the Obama administration requested $4.5 billion for the FDA in the budget for FY2013—up 17% from FY2012. Newly proposed fees paid by makers of generics and biosimilars would cover 98% of that boost in agency spending under the Protecting Patients Initiative. Some stakeholders are urging Congress to approve the new user fees, whereas others are wary of making FDA rely so heavily on fees instead of appropriations. “We endorse a clear, science-based, separately funded regulatory program for biosimilars that is supported by a mix of appropriations dollars and user fees,” says Sascha Haverfield-Gross, who is vice president of Pharmaceutical Research and Manufacturers of America in Washington, DC. Officials at the Generic Pharmaceutical Association (GphA), also in Washington, DC, are less enthusiastic. “The funding provided by the user fee programs is in addition to, not a substitute for, congressional appropriations,” says Ralph G. Neas, GphA president and CEO. Some organizations are even queasier about user fees, particularly as Congress is expected to appropriate only $2.5 billion of the $4.5 billion requested. “The key thing to watch is the actual budget appropriation and not the user fees,” says Margaret Anderson, executive director of FasterCures, speaking for the Washington, DC–based consortium, Alliance for a Stronger FDA.


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Fox, J. Biosimilar fees plug FDA deficit. Nat Biotechnol 30, 298 (2012).

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