WASHINGTON, D.C. (August 23, 2021) – Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Stephen J. Ubl issued the following statement today on the release of the Prescription Drug User Fee Act (PDUFA) VII performance goals letter:

“For nearly 30 years, the Prescription Drug User Fee Act (PDUFA) has helped the U.S. Food and Drug Administration (FDA) fulfill its central mission to help protect and advance the public health by allowing the Agency to keep pace with the number and complexity of innovative drugs and biologics entering the regulatory review pipeline.

“The PDUFA VII agreement released today is an important step forward to continue to support patient safety, maintain the FDA’s high standards of independent regulatory review and promote timely access to safe and effective medicines for patients. It is also an opportunity to advance innovative research and development and review approaches to prepare for the future of drug development, including leveraging applicable lessons learned from the COVID-19 pandemic.

“With the release of the proposed PDUFA VII Performance Goals Letter for public discussion, PhRMA looks forward to working with Congress, the administration, patient and medical provider groups, the FDA and other stakeholders to ensure timely reauthorization of this important program as we continue working together to help patients live longer, healthier lives.”

Key provisions in the PDUFA VII performance goals letter include:

• Enhancing patient-centric drug review, such as the incorporation of patient-centric data into drug development and regulatory reviews and supporting safety monitoring.
• Supporting the next wave of advanced biological therapies such as cell and gene therapies and facilitating broader use of novel trial designs and approaches for rare and ultra-rare diseases.
• Modernizing regulatory evidence generation and drug development tools, such as advancing the use of real-world evidence for regulatory decision-making.
• Advancing digital technologies and information technology (IT) infrastructure and modernizing FDA’s data and IT capacity and capabilities, including adoption of cloud-based technologies.
• Enhancing innovation in manufacturing and product quality reviews, including incorporating best practices from COVID-19 lessons learned.
• Strengthening scientific dialogue and advancing innovation through expanding opportunities for obtaining FDA regulatory feedback and clarity throughout the drug development process.
• Enhancing FDA hiring, retention and financial management.

About PhRMA

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested more than $1 trillion in the search for new treatments and cures, including $91.1 billion in 2020 alone.

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