Originally Published IVD Technology April 2005
INDUSTRY NEWS
FDA aims to meet user-fee obligations
Matt Grebow
Like other U.S. agencies, FDA has faced increasing budget scrutiny in recent years. Its fiscal 2006 request would limit program-level increases to $80.9 million, 4.5% more than last year. However, IVD industry observers will have a close eye on a fraction of these funds—those that relate to the Medical Device User Fee and Modernization Act (MDUFMA).
FDA is requesting $6.4 million more in user fees for medical device review, bringing the total MDUFMA user-fee request to $40.3 million for 2006. In addition, the agency is requesting just under $6 million in budget authority for the Devices and Radiological Health Program, which FDA says will enable it to meet its minimum statutory appropriation level for FY2006.
Overall, FDA estimates that the appropriation for the Devices and Radiological Products Program for 2006 will be almost $221 million, including $138,000 in makeup funds from fiscal 2005. A final amount will be set next month when the Bureau of Labor Statistics releases its Consumer Price Index figures for April 2005.
According to FDA, the requested budget authority, in conjunction with existing MDUFMA user fees, will allow the agency to meet its fiscal 2006 performance goals of issuing decisions on 80% of premarket approval (PMA) applications within 320 days and on 75% of 510(k) submissions within 90 days (these percentages are set to rise to 90% and 80%, respectively, in 2007).
Overall, the agency claims that user fees have been a boon to the review process. “We have used user-fee resources to attract more than a dozen diverse new review staff with cutting-edge skills in genomics, proteomics, and molecular diagnostics, as well as in traditional areas of lab medicine including chemistry, hematology, and microbiology. These new hires have provided us with staff to make quick and informed review decisions,” says Cynthia Benson, a representative for FDA’s Center for Devices and Radiological Health.
AdvaMed (Washington, DC) also sees encouraging trends, although the approval process itself has remained mostly unchanged. “It’s not clear whether there has been any streamlining or improvement because of MDUFMA,” explains an AdvaMed spokesperson, who adds that user fees do appear to be moving the PMA application and 510(k) approval processes in the right direction. “What MDUFMA has done is to give FDA more resources. From FDA data for fiscal 2003, it appears they are meeting performance goals that are in place for fiscal 2005. But there has been no change in the process, so to speak.”
However, some in the industry have expressed concern about the ambiguity of FDA’s data. Although regulatory experts acknowledge the earnestness of the agency’s review objectives, it is not clear, for instance, how many decisions FDA may label as not approvable and then resolve in later applications.
Still, with Congress gearing up to tackle legislation forgiving appropriations shortfalls for fiscal 2003 and 2004 and with discussions on the bill’s reauthorization to follow, it may be another year before the future of user fees comes into focus. Until then, many in the industry will be watching closely.
Copyright ©2005 IVD Technology
