1.0 INTRODUCTION

The Prescription Drug User Fee Act (PDUFA) enacted in 1992 provided authority for FDA to collect additional resources (fees from industry) and enable FDA to accelerate its drug evaluation process without compromising review quality. Since 1992 PDUFA has seen a progression of performance commitments designed to speed drug development and approval while preserving and even raising FDA’s high standards for safety, effectiveness, and product quality. Congress reauthorized PDUFA in 1997 under the FDA Modernization Act (FDAMA) and again in 2002 under the Public Health Security and Bioterrorism Preparedness and Response Act. Most recently Congress reauthorized PDUFA for another five years under the Food and Drug Administration Amendments Act of 2007 (FDAAA).

The original focus in the early years of the PDUFA program was getting quality products to market faster by significantly increasing the resources devoted to reviewing drug product applications and by requiring strict management and specific performance goals and targets. Beginning with PDUFA III in 2002, the PDUFA program was expanded to provide an increased focus on managing the risks of drug products that have been approved for marketing. PDUFA III authorized additional resources for risk management plan activities at pre-NDA and pre-BLA meetings, during the review of NDAs and BLAs, and during the period two-to-three years after approval. In addition, FDA met a PDUFA III goal by developing final guidance documents on good risk assessment, risk management, and pharmacovigilance practices1. PDUFA IV authorizes a significant expansion of the post market focus under the PDUFA program.

Under the PDUFA IV program, $29.29M (plus an annual inflation factor) will be allocated annually to enhance the Agency’s drug safety capabilities. With these funds, FDA will be able to increase the number of employees dedicated to safety evaluation of marketed medications. FDA will also be able to add resources for adopting new scientific approaches to drug safety, reducing the risk of medication errors, improving the utility of existing tools for detection and prevention of adverse events, and incorporating the new approaches into the Agency’s drug safety program.

Click here to view the entire document.