Prescription Drug User Fee Act (PDUFA): 2017 Reauthorization as PDUFA VI

Summary

The Prescription Drug User Fee Act (PDUFA) is being considered by Congress for reauthorization. First passed by Congress in 1992, it 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 products sold in the United States. 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.

FDA’s review of drug applications is funded through a combination of annual discretionary appropriations from Congress and user fees collected from the pharmaceutical industry. Congress 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. At each reauthorization, 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 concentrated on new measures concerning postmarket drug safety.

PDUFA V maintained the PDUFA IV scope of activities that PDUFA fees could support.

FDA plays an important role in the reauthorization process for PDUFA. In July 2015, the agency held an initial public meeting at the start of the reauthorization process. From September 2015 through February 2016, FDA held negotiations with the pharmaceutical industry and met with consumer and patient advocacy groups. In July 2016, FDA published a notice in the Federal Register announcing the availability of the proposed PDUFA VI commitment letter, as well as a public meeting to discuss the proposed recommendations for the PDUFA VI reauthorization. A public meeting to discuss the proposed recommendations for reauthorization of PDUFA was held on August 15, 2016, and the final agreement (“Commitment Letter”) between FDA and industry has been submitted to Congress. The PDUFA VI commitment letter is posted on the FDA website. On April 25, 2017, the Senate introduced its user fee legislation (S. 934, the FDA Reauthorization Act), which would reauthorize the four expiring user fee agreements. The Senate Health, Education, Labor and Pensions (HELP) Committee approved the bill on May 11, 2017. The House introduced its version of the FDA Reauthorization Act (H.R. 2430) on May 16, 2017, and referred the bill to the House Energy and Commerce Subcommittee on Health, which approved it by voice vote on May 18, 2017. The full Committee approved the bill on June 7, 2017. (This report will be updated to reflect the enacted statutory language.)