Alliance’s Bens Presents at August PDUFA VI Public Meeting

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The Alliance’s Vice President of Public Policy Cynthia Bens was invited by the U.S. Food and Drug Administration (FDA) to speak on two panels at an August 15 public meeting focused on the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA allows for collection of user fees from drug manufacturers by the FDA to help fund the drug review process.

A few weeks ago, the FDA released its Commitment Letter, which outlines its performance goals and procedures for PDUFA VI. The August 15 meeting was held to gather input from a variety of stakeholders on this document.

Bens participated on two panels: Pre-Market Review and Post-Market Safety and Administrative Enhancements: Hiring, IT, and Financial.

For the Pre-Market Review and Post-Market Safety panel, Bens presented comments on Section I of the Commitment Letter, which would ensure the effectiveness of the human drug review program. She noted the Alliance supports the FDA’s goals to dedicate staff resources within the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), to promote early consultation on the use of new surrogate endpoints, streamline the development of combination products, and support the Breakthrough Therapy Program.

She followed up with additional comments during the third panel of the day that addressed the improvements to FDA hiring and staff retention outlined in Section III of the commitment letter.

In her written comments she noted, “We believe that PDUFA VI will ensure that FDA can hire and retain a strong scientific and medical workforce to advance its mission to protect and promote public health, so the Alliance for Aging Research is supporting all of the provisions under Section III.“

To read the entirety of Bens’ comments, please go here.

The Alliance is submitting full comments to the FDA next week on the Commitment Letter, including feedback on proposals to advance Patient-Focused Drug Development, model-informed drug development, adaptive trial designs, and a framework for assessing benefit-risk. Please check back to the Alliance’s blog regularly for additional information.