FY 2014 appropriations omnibus legislation to restore $85 million in industry-provided user fees that were lost to FDA in FY 2013 due to the sequester.
The FY 2014 omnibus also provides for additional funding for FDA in the form of $91 million above FY 2013 enacted funding levels. These added funds increase FDA’s budget above pre-sequestration levels and will help the agency continue to fulfil its mission to promote and protect the public health.
Leaders from across the biotech, pharmaceutical and medical device industries stood side by side in maintaining that user fees paid by industry to FDA should not be treated the same way as taxpayer appropriated dollars. Instead, user fees are part of an agreement between industry, FDA and Congress under which industry agrees to supplement FDA’s appropriated budget, and the agency agrees to performance commitments designed to increase the efficiency and predictability of the review process. Restoring these user fee funds upholds that agreement.