BIO Statement on Prescription Drug User Fee Act Goals Letter

Washington, D.C. (July 15, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement today regarding the Prescription Drug User Fee Act (PDUFA) VI goals letter:

“Since 1992, PDUFA has played a vital role in enhancing the ability of the Food and Drug Administration (FDA) to ensure patients receive timely access to safe and effective innovative medicines. We believe the goals and commitments reflected in the thoughtful and carefully negotiated PDUFA VI goals letter will build upon the historic successes of PDUFA in evaluating drug safety, improving the drug development process, and increasing the speed, efficiency, and predictability of the FDA’s drug review process. 

“PDUFA VI resources, together with FDA commitments to achieve greater efficiency in hiring as well as to increase financial stability and sustainability, will provide the agency with the expertise, tools, and resources it needs to effectively perform its vital mission. We are especially pleased by the steps that will be taken in PDUFA VI to advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions.

“We look forward to working with Congress, the administration, patient and provider groups, and all stakeholders to ensure that PDUFA is reauthorized in a timely manner and that the important enhancements to the program envisioned in the goals letter are implemented most effectively.

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