WASHINGTON -- Some form of user fees will almost certainlybe instituted at the Food and Drug Administration in the nextyear or two, according to key Senate and House staff members.

The White House has allocated funds from user fees in the1992 FDA budget, and even traditional opponents of user feesin the Congress are supporting them as the best way toincrease FDA funding.

Sen. Orin Hatch, R-Utah, and Rep. John Dingell, D-Mich., aredrafting legislation authorizing the FDA to collect user fees,members of their staffs told the annual meeting here of theAssociation of Biotechnology Companies (ABC).

Dingell's approach involves a registration fee, said LesleyRussell, a staffer on the House Committee on Energy andCommerce. Unlike Bush administration proposals forapplication and other fees, the registration fee would bemodest -- $1,000 to $5,000 per company per year -- and wouldbe imposed on all entities under FDA jurisdiction, not just thoseapplying for FDA approvals or licenses. Registration would beexpanded from the current 40,000 pharmaceutical and medicaldevice and research companies to about 100,000 food, drugand cosmetic companies.

ABC President Martin Nash on Tuesday announced theassociation's continued opposition to any form of user fees.

Industry organizations, including the Industrial BiotechnologyAssociation and the Pharmaceutical Manufacturers Association,are scheduled to testify Thursday on user fees and otheraspects of FDA appropriations at a hearing before theagriculture subcommittee of the House AppropriationsCommittee.

-- Steve Usdin BioWorld Washington Bureau

(c) 1997 American Health Consultants. All rights reserved.

No Comments