The timely reauthorization of PDUFA will allow FDA and biopharmaceutical companies to build on the incredible strides made during the previous PDUFA cycle.
PDUFA VII is critical for future biopharmaceutical innovation and for patients.
Today, the U.S. Food and Drug Administration (FDA or Agency) released its performance goals letter for the seventh installment of the Prescription Drug User Fee Act (PDUFA).
PDUFA was first enacted in 1992 as a bipartisan solution to the then long FDA regulatory review timelines for new drugs and biologics. To this end, PDUFA allows the Agency to collect fees from biopharmaceutical companies to augment Congressional appropriations to increase FDA’s staffing and other resources to speed and enhance review process to help ensure patients have timely access to life-saving treatments. The PDUFA program helps provide efficiency and predictability of regulatory review while supporting continued independent rigor by the science-based Agency.
The PDUFA program has been critical in supporting the FDA’s ability to fulfill its central mission – to help protect and advance the public health. Thanks in part to PDUFA, the U.S. now leads the world in delivering new medicines to patients, and the FDA’s human drug review program is the global gold standard for regulatory review and approval. Before PDUFA, it often took FDA more than two years to review new medicines. Now, the median review time for a new medicine is 10 months for standard applications and 8 months for priority review applications.
The PDUFA VII goals letter expands upon the most recent iteration of the user fee agreements which expire in September of 2022 with a renewed focus on strengthening review fundamentals, enhancing accountability and transparency and advancing innovation for patients.
Key areas of the PDUFA VII goals letter include:
In adapting to and meeting the challenges presented by the COVID-19 pandemic, FDA and the biopharmaceutical industry are utilizing novel approaches to clinical trials and facility inspections to support continued innovation and inform efficient regulatory decision-making. PDUFA VII includes commitments that advance COVID-19 lessons learned, such as increased use of digital technologies and alternative tools to assess manufacturing facilities.
The PDUFA VII agreement will have a lasting and meaningful impact on the biopharmaceutical industry’s ability to develop innovative, safe and effective medicines for patients in a timely manner.
The timely reauthorization of PDUFA will allow FDA and biopharmaceutical companies to build on the incredible strides made during the previous PDUFA cycle. New developments in medical and fundamental science – including immunotherapies and cell and gene therapies – hold the promise of treating debilitating diseases such as cancer, diabetes and many rare disorders. Fulfilling this promise depends on a modern regulatory framework that PDUFA facilitates and that can serve patients by providing timely, science-based regulatory decisions. It is critical that Congress reauthorizes PDUFA, and supports the independent work of FDA, before its expiration in September 2022.
To learn more about PDUFA VII, click here.
