User fee raise of about 20% under discussion between FDA and industry.
Executive Summary
FDA/INDUSTRY USER FEE REAUTHORIZATION DISCUSSIONS FOCUSING ON 20% RAISE in user fees as the agency and brand name pharmaceutical industry seek to reach an agreement in time for the opening of the 105th Congress. FDA is understood to have been seeking roughly a doubling of the fees in exchange for expanded services. The agency, however, could be willing to accept an increase of about 20% to cover a lesser package of commitments on the review process.