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Setting the Stage for PDUFA VI: Recap of Stakeholder Briefing

July 26, 2016
On July 15, 2016, the U.S. Food and Drug Administration (FDA) released the Prescription Drug User Fee Act (PDUFA VI) Goals Letter for fiscal years 2018 through 2022.  The Goals Letter, thoughtfully negotiated by the FDA and biopharmaceutical industry with input from the patient and provider stakeholder communities, outlines the performance goals committed to by the FDA and the biopharmaceutical industry to evaluate drug safety, improve the speed and efficiency of the FDA’s drug review process, and incorporate patient perspectives in drug development and regulatory decision-making.

The PDUFA program was first implemented in 1992 to increase the efficiency of drug review at the FDA.  The goal was simple: to decrease review times for new drug applications.  Since PDUFA I, each reauthorization of the program built upon its prior successes and increased its scope of activities to provide more timely patient access to safe and effective new medicines.  The last reauthorization, PDUFA V, saw a commitment from the FDA to hold 20 meetings (FDA actually will hold 24), each focused on a specific disease area, with patients, caregivers, and advocates to better understand patient perspectives in those specific therapeutic areas.  PDUFA VI looks to operationalize the lessons learned from those meetings by developing methodologically sound approaches to the collection of patient input and providing clear guidance for stakeholders to advance the science of patient-focused drug development.

The reauthorization process for PDUFA VI began July 2015 with a series of public stakeholder meetings over the course of six months to collect different perspectives and learn how the FDA can continue to strengthen the drug review process, advance patient involvement in drug development, and bring patient perspectives more clearly to bear on regulatory decisions.

Last week, BIO and PhRMA co-hosted a briefing to review the PDUFA VI Goals Letter and timeline for reauthorization.  The briefing was attended by over 45 patient and provider groups, representing numerous therapeutic areas.  BIO and PhRMA leadership who were directly involved in the technical negotiations with the FDA provided attendees with an overview of the commitments outlined in the Goals Letter while Marc Boutin, JD, Chief Executive Officer of the National Health Council and Jeff Allen, Executive Director of Friends of Cancer Research, discussed the importance of the advancements in the Goals Letter to the patient community.

The PDUFA VI Goals Letter is available on FDA’s website here.  The FDA is accepting electronic and written comments from the stakeholder community through Monday, August 22, 2016.  Instructions on how to submit comments are available on the Federal Register Notice here.

The FDA will host a final public meeting to discuss the Goals Letter on Monday, August 15, 2016, from 9:00 AM to 2:00 PM, EST, at the FDA’s White Oak Campus in Silver Spring, MD.  If you would like to participate in this meeting, please register here by Monday, August 8, 2016.