FDA,FY 2000 Performance Report for the Prescription Drug User Fee Act of 1992,PDUFA Introduction

Introduction

In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA). PDUFA authorized FDA to collect fees from companies that produce human drug and biological products. The original PDUFA had a five-year life; it ended in 1997, the same year Congress passed the FDA Modernization Act (FDAMA). FDAMA contained a five-year reauthorization of PDUFA (PDUFA II).

PDUFA requires FDA to submit two annual reports to Congress for each fiscal year during which fees are collected: 1) a performance report due within 60 days of the end of the fiscal year, and 2) a financial report due within 120 days of the end of the fiscal year. This document fulfills the first of these requirements for Fiscal Year 2000.

PDUFA provides FDA with additional revenue to hire more reviewers and support staff and upgrade its information technology to speed up the application review process for pharmaceutical and biological products without compromising review quality.

In consultation with industry and the Congress, FDA agreed to meet a set of review performance goals that become more stringent each year. These goals applied to the review of original new product applications, resubmissions of original applications, and supplements to approved applications. FDA met or exceeded every PDUFA I performance goal and has met or exceeded nearly every PDUFA II performance goal.

Under PDUFA II, the review goals continue to shorten. By 2002, the PDUFA II goals call for FDA to review and act on 90 percent of:

Standard new drug and biological product applications and efficacy supplements within 10 months
Priority new drug and biological product applications and efficacy supplements (i.e., for products providing significant therapeutic gains) within 6 months
Manufacturing supplements within 6 months, and those requiring prior approval within 4 months
Class 1 resubmissions within 2 months, and Class 2 resubmissions within 6 months.

In addition, PDUFA II added a new set of procedural goals intended to improve FDA's responsiveness to and communication with industry sponsors during the early years of drug development. These goals specify timeframes for activities such as scheduling meetings and responding to various sponsor requests. Whereas PDUFA's original intent was to speed up the review process, PDUFA II's intent is to speed up the entire drug development process.

This report focuses on two aspects of PDUFA performance. Like previous performance reports, it measures the Agency's performance toward the agreed-upon numeric goals for reviewing and acting on submissions and responding to sponsors' pre-submission requests. In addition, it also reports on stakeholders' perceptions of PDUFA performance based on testimony from a public meeting held on September 15, 2000.