Senate is developing competing bill, howeverThe cost of doing business in the near future with the Food andDrug Administration just dropped again. House of Representativesstaffers working on a bill to assess user fees to manufacturerssubmitting
The cost of doing business in the near future with the Food andDrug Administration just dropped again. House of Representativesstaffers working on a bill to assess user fees to manufacturerssubmitting devices for FDA approval have amended the legislationto reduce the amount of the fees. Other amendments have been addedto enlist industry support for user-fee legislation (SCAN 6/29/94).
The carefully crafted compromise could unravel, however, dueto competing legislation developed by a Senate Appropriationssubcommittee. That bill would raise $150 million in medical deviceuser fees, to be devoted to reducing a shortfall in the FDA'sdeficit instead of erasing the backlog of product applicationsat the agency.
Industry representatives testified on device user fees at ahearing held July 14 in the House subcommittee on health and environment,chaired by Rep. Henry Waxman (D-CA). Most of the companies onhand stated that the House bill, the Medical Device User Fee Act(H.R. 4728), represented a bitter pill that industry could swallowas long as revenues from the fees are dedicated to improving theFDA's efficiency and reducing the backlog of product approvals.
Industry representatives were also concerned about settingperformance goals that the FDA must meet in order to receive userfees. While performance goals were not included in the legislation,a letter from FDA chief David Kessler supporting performance goalshas been appended to the bill. Industry would also like to seea sunset clause attached to the bill calling for the eliminationof user fees after five years.
User fees were lowered by staffers writing the bill, with feesfor a pre-market approval (PMA) application or product licenseapplication (PLA) falling from $62,000 to $52,000. The cost ofa 510(k) filing fell to $3200.
The Senate Appropriations subcommittee on agriculture, ruraldevelopment and related agencies, however, passed a competingbill for the FDA's budget that would levy $150 million in deviceuser fees and use the money for general budget purposes ratherthan the product approval process. The appropriations bill wouldstand if H.R. 4728 is not enacted, according to Robin Wiley, managerof legislative and regulatory affairs for the National ElectricalManufacturers Association.
NEMA is mobilizing its members to oppose the Senate AgricultureCommittee's bill, Wiley said.
"We would much rather see (user-fee appropriations) goto FDA and be targeted specifically to the product approval process,"Wiley said.