The FDA User Fee Act has been approved by both the U.S. Senateand the House of Representatives. The Senate passed the bill onWednesday and the House approved it on Tuesday. PresidentBush has already expressed support for the measure.

The bill would assess companies $100,000 for new drugapplications. The fees would be used to hire new productreviewers at the FDA and accelerate the drug-approvalprocess. Companies with fewer than 500 employees that havenot yet received their first product approval would pay halfthe fee rate.

A proposal by Sen. Edward Kennedy, D-Mass., to create a one-year deferral of the reduced new product fee for smallcompanies was also included in the final version of the bill,according to the Industrial Biotechnology Association (IBA).

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