BIO issued letters today encouraging support for programs and initiatives of critical importance to our industry as appropriators develop the Fiscal Year 2015 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act.
Perhaps most importantly, we emphasize the importance of a strong, fully-funded FDA with the resources necessary to keep pace with rapidly-evolving biomedical science and to make sound regulatory decisions in a timely and efficient manner. We are requesting a total of $2.784 billion in Budget Authority for the FDA, $200 million above the President’s Budget Request.
Specifically, we are recommending the following:
Human Drugs and Biologics Programs - For FY 2015, we recommend an investment of an additional $100 million in FDA’s medical products programs, including a total of $528 million for the Human Drugs Program and the $231 million for the Biologics Program.
Advancing Regulatory Science: We support adequate funding for FDA’s Advancing Regulatory Science Initiative, which builds upon existing FDA programs to transform the way medical products are developed, evaluated, and manufactured.
Medical Countermeasures Initiative: BIO requests that the Committee provide $25 million for FDA’s Medical Countermeasures Initiative. This initiative was launched in August 2010 in response to the HHS’s comprehensive review of the Public Health Emergency Medical Countermeasures Enterprise.
Sequestration of Industry User Fees: In FY13, more than $80 million of industry user fees paid to the FDA to support FDA review programs were inappropriately sequestered and made unavailable to the Agency. BIO was encouraged that the Consolidated Appropriations Act of 2014 averted sequestration in the near term and that subsequent FDA appropriations restored the industry user fees that had been previously sequestered in FY13. However, user fees are still in danger of being negatively impacted by sequestration in the future. Because of this, BIO strongly supports the passage of the FDA User Fees Protection Act (S.1413) or other measures clarifying that private sector user fees paid to FDA are exempt from sequestration.
Drug Quality and Security Act of 2013 Implementation: BIO also supports additional funding for FDA oversight of pharmacy compounding and implementation of the supply chain traceability provisions of the Drug Quality and Security Act of 2013.