On June 12, 2007, the Deputy Commissioner for Policy of the FDA appeared before the House of Representatives (Subcommittee on Health) to discuss the reauthorization of the prescription drug user and medical device user fee programs. These programs are set to expire in September 2007 and the FDA is requesting that reauthorization be granted so that there is no gap between the expiry of the old law and implementation of a new law. The FDA's proposal for higher fees is meant to enhance pre-market review and create a modern post-market drug safety system that tracks products through their full life cycle. Specifically, the FDA's proposal calls for high fees to allow it to improve its information technology infrastructure moving the FDA towards an all electronic drug review system that would help ensure the best collection, evaluation, and management of the vast quantity of post-market safety surveillance data received.
The full text of Randall Luter's remarks is available on the FDA web-site at http://www.fda.gov/ola/2007/userfeeact061207.html