PhRMA & BIO Establish Industry PDUFA Tracking Database

Data to Inform Ongoing Collaboration under PDUFA V

07.02.13 | By Sascha Haverfield, Ph.D.

As a recent update on implementation of the Prescription Drug User Fee Act (PDUFA) explained, a new review program for new molecular entity (NME) new drug applications (NDA) and original biologic license applications (BLA) was established under PDUFA V to promote greater transparency and provide more opportunities for communication between biopharmaceutical companies and the Food and Drug Administration (FDA).

The overall success of the new NME Review Program will be determined based on whether it improves the rate of “on-time, first-cycle” successes – the number of new medicines that are fully reviewed and for which definitive regulatory action is taken within the target timeframe. 

Industry PDUFA Tracking Database

PhRMA and the Biotechnology Industry Organization (BIO) recently announced the launch of an Industry PDUFA Tracking Database to track member companies’ experience with the Program in real time through a comprehensive collection of data on NME and non-NME applications. 

The Database is available to all PhRMA and BIO member companies to facilitate the collection of real-time data during the FDA review process by individual drug and biologic sponsors.  It went live on April 1st.

The Database is designed to capture relevant metrics in order to evaluate the efficiency of FDA’s regulatory review process for NME and non-NME applications, including the metrics necessary for independent assessment of the PDUFA V NME Review Program.

The Database tracks the progression of applications throughout the entire FDA review cycle including information regarding major FDA actions and significant FDA-sponsor communications such as FDA review outcomes, timeliness of regulatory action, time to approval, and number of review cycles as well as significant sponsor/FDA interactions and the Advisory Committee meeting. 

Facilitating a Constructive, Ongoing Dialogue with FDA

PhRMA and our member companies are taking a continuous improvement, lifecycle approach to PDUFA implementation rather than waiting for the next reauthorization to raise issues of concern or opportunities to utilize new advancements.  Science and technology evolve over time, and we can’t wait five years between reauthorizations to evaluate whether FDA is implementing PDUFA in a manner that best serves the needs of patients waiting for new medicines. We want the latest technology and information to drive and accelerate biomedical innovation and strengthen FDA’s critically important, high standards of safety and efficacy.

The Industry PDUFA Tracking Database is one of the tools to build a robust fact base that will enable constructive continuous dialogue between biopharmaceutical companies and relevant stakeholders, including discussions regarding any necessary course corrections (by FDA or by industry) throughout the implementation of PDUFA V.

The Database will provide independent measures of the performance of the regulatory review process under PDUFA V.  The aggregated data and analyses derived from the collected drug review information will be used to inform the development of industry advocacy positions and industry’s approach to PDUFA V implementation and future cycles of PDUFA negotiations.

PhRMA plans to publish selected findings once we have adequate data to analyze trends.

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