Abstract
Originally enacted to address the delays in US Food and Drug Administration (FDA) new drug review due to chronic understaffing and outdated systems, the Prescription Drug User Fee Act (PDUFA) of 1992, with its 5-year reauthorization cycle, enabled rapid rigorous review and ushered in a new era of continuing program innovation, evaluation, and improvement. This has resulted in a scientifically and financially strong program with transparent stakeholder engagement as a routine way of doing business. The enhancements to the process of human drug review, conducted in the FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), originally focused on the FDA review of a new drug application, have evolved and expanded to include extensive communication and consultation between drug sponsors and FDA throughout drug development, advances in regulatory science applied to drug development and regulatory oversight, strengthening and innovating approaches to post-market safety, increasing patient focus and modernizing supporting informatics. These enhancements, identified and supported in successive rounds of user fee negotiation with regulated industry, have enabled the USA to sustain global leadership in drug innovation, and earlier patient access to safe and effective new medicines.
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Notes
45 in FDA Center for Drug Evaluation and Research (CDER), 12 in FDA Center for Biologics Evaluation and Research (CBER).
A type A meeting is a meeting to help an otherwise stalled development program. A type B meeting is for pre-IND, pre-NDA/BLA, and certain end of phase meetings. A type C meeting regards any other matter. See: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM153222.pdf.
Generally, this refers to a qualified consulting or accounting firm hired through competitive procedures and paid for with FDA-administered fee funds.
Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of all FDA-regulated products. See: http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/default.htm?utm_campaign=Goo.
Note: These PFDD meetings are distinct from Advisory Committee meetings, which routinely include lay persons.
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Neither Dr. Mullin nor Mr. Barton received any funding for this article.
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Dr. Mullin and Mr. Barton are employees of the US Food and Drug Administration (FDA).
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Mullin, T.M., Barton, J.L. US Prescription Drug User Fee Act (PDUFA): An Introduction for the Pharmaceutical Physician. Pharm Med 31, 7–12 (2017). https://doi.org/10.1007/s40290-016-0170-6
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DOI: https://doi.org/10.1007/s40290-016-0170-6