	Introduction

In 1992, the Prescription Drug User Fee Act (PDUFA, now called PDUFA I) gave the Food and Drug Administration (FDA) the authority to collect fees from the pharmaceutical industry and to use the revenue to support "the process for the review of human drug applications." The most recent reauthorization was Title I of the Food and Drug Administration Reauthorization Act (FDARA, P.L. 115-52 ), which extends the user fee program through September 30, 2022. Congress first passed PDUFA to supplement the FDA budget outside of direct appropriations from Congress. Industry, consumer groups, and FDA agreed that the time from submission of a drug or biologics application to FDA's decision was unacceptably long. FDA Drug Review and PDUFA Coverage

Prior to marketing a drug, a manufacturer must submit to FDA a new drug application (NDA) demonstrating that the drug is safe and effective for its intended use. With subsequent reauthorizations, Congress has amended that definition to expand the scope of activities covered by PDUFA. PDUFA II expanded the range of activities for which FDA could use prescription drug user fee revenue to include those related to preclinical and clinical trial phases of a new drug's development. PDUFA III extended the range of activities for which FDA could use prescription drug user fee revenue to include three years into the postapproval and marketing period. PDUFA IV removed the three-year limitation on postapproval activities and again expanded the list of postmarket safety activities that the fees could support. PDUFA V and VI did not change the definition of the "process for the review of human drug applications," thus maintaining the PDUFA IV scope of activities that fees could support. PDUFA I connected prescription drug user fees to performance goals and targets. PDUFA Impact on Review Time and FDA Budget

		Review Time

The approval times for NDAs and BLAs provide a measure of PDUFA's effectiveness in meeting its primary goal: reducing the time between a manufacturer's submission of an NDA/BLA and FDA's approval decision. PDUFA VI Package

The PDUFA VI package consists of two parts: (1) the performance goals and procedures agreement between FDA and industry, which this report refers to as the Commitment Letter or the Agreement (summarized in Appendix A ), and (2) statutory language that reauthorizes the program (summarized in Appendix B ). The timeline for the development of the Agreement and the reauthorization of the program is shown in Figure 3 . On April 25, 2017, user fee legislation was introduced in the Senate ( S. 934 ) that would have reauthorized PDUFA and the three other human medical product user fee programs, among other things. 2430 was signed into law as FDARA ( P.L. Title I reauthorizes PDUFA, allowing FDA to collect fees and use the revenue to support specified activities for the review of prescription brand-name drugs. FDARA includes eight other titles. A separate CRS report describes provisions in those titles, which cover reauthorization of the medical device, generic drug, and biosimilar biological product user fees, as well as provisions concerning pediatric drugs and devices, reauthorizations and improvements related to drugs, inspections and regulatory improvements related to devices, improvements to generic drug access, and a set of miscellaneous provisions.
The Prescription Drug User Fee Act (PDUFA, now called PDUFA I) was reauthorized as PDUFA VI by the Food and Drug Administration Reauthorization Act of 2017 (FDARA, P.L. 115-52). First passed by Congress in 1992, PDUFA gave the Food and Drug Administration (FDA) the authority to collect fees from the pharmaceutical industry and to use the revenue to support "the process for the review of human drug applications." FDA regulates the safety and effectiveness of drug and biological products sold in the United States. Prior to marketing a drug, a manufacturer must submit to FDA a new drug application (NDA) or a biologics license application (BLA) demonstrating that the product is safe and effective for its intended use.
FDA's review of NDAs and BLAs is funded through a combination of annual discretionary appropriations from Congress and user fees collected from the pharmaceutical industry. Prior to FDARA, Congress had last reauthorized PDUFA, for a five-year period, through September 30, 2017, via Title I of the Food and Drug Administration Safety and Innovation Act (FDASIA, P.L. 112-144).
User fees provided 65% of the Human Drugs Program funding for FY2016, accounting for 3,351 full-time equivalent employees. Therefore, as each reauthorization deadline approaches, FDA, industry groups, and many Members of Congress generally see PDUFA and the other human medical product user fees as must-pass legislation. Congress originally intended PDUFA to diminish the backlog of new drug applications at FDA and shorten the time from submission to decision. The general view is that PDUFA has succeeded. FDA has added review staff and reduced its review times. Throughout the reauthorizations, stakeholders (e.g., FDA, industry, and patient groups) have raised different concerns in the context of PDUFA, resulting in changes to the scope of activities covered by PDUFA. For example,
PDUFA II expanded the user fee program's scope to include activities related to the investigational phases of a new drug's development, and to increase FDA communications with industry and consumer groups. PDUFA III again expanded the scope of activities that user fees could support to include a three-year postapproval period. PDUFA IV removed the three-year limitation on postapproval activities and concentrated on new measures concerning postmarket drug safety.
PDUFA V and VI maintained the scope of activities that PDUFA fees could support, and these fees now generally cover the full lifecycle of the drug product. Each reauthorization has connected prescription drug user fees to performance goals and targets, negotiated between FDA and the pharmaceutical industry. Over time, these goals have changed to reflect advancements in the regulatory science surrounding drug development.
Similar to previous reauthorizations, the PDUFA VI package consists of two parts: (1) statutory language that reauthorizes the program and (2) the performance goals and procedures agreement between FDA and industry for FY2018 through FY2022.
Title I of FDARA reauthorizes PDUFA, allowing FDA to collect fees and use the revenue to support specified activities for the review of prescription brand-name drugs and biologics. Additionally, FDARA includes eight other titles that reauthorize the medical device, generic drug, and biosimilar user fee programs through FY2022; modify the drug and device regulatory processes to encourage the development of drugs and devices for pediatric use; amend the law regarding medical device, prescription drug, and generic drug regulation; and make changes in several cross-cutting areas, such as annual reporting on inspection and analysis of use of funds.