US FDA: No Savings From Outside Review, Says CBO

The overall cost to the US federal government of implementing Senator Nancy Kassebaum's Food and Drug Administration's reform legislation, Bill S 1477, would be $55 million over a period of six years, according to estimates produced this month by the Congressional Budget Office. Most of the additional costs resulting from the bill would arise from the increased workload which S1477 would place on the agency, it says.

In the CBO's view, using outside experts to conduct product reviews instead of staff would save no money at all. "Outside reviewers would conduct the same number of reviews and would be required to meet the same quality standards as the FDA, and therefore would use the same level of resources as the agency currently does in conducting product reviews," it says.

Assuming that existing volume and quality standards for reviews were to remain constant, says the CBO, the FDA would need additional staff and other resources to reduce review times significantly and eliminate the backlog of product submissions. "Since S1477 would relax current FDA regulations somewhat, the number of product applications would probably increase," it says. "The additional personnel and resources necessary to meet the proposed deadlines would exceed any savings realized through regulatory relief offered by S1477," it adds.