The Prescription Drug User Fee Act: Much More Than User Fees.

ABSTRACT:

Background

The Prescription Drug User Fee Act (PDUFA) is due for reauthorization in 2022. Beyond creating the user fee program which now generates a majority of the Food and Drug Administration (FDA) Human Drugs Program budget, PDUFA has made numerous additional changes to FDA policy during its 29-year history. FDA's budgetary dependence on user fees may advantage the industry in negotiating favorable policy changes through PDUFA.

Methods

The full texts of all prior PDUFA reauthorization bills and all submitted public comments and meeting minutes for the 2022 reauthorization were reviewed. Provisions affecting FDA regulatory authority and processes were identified.

Findings

PDUFA legislation has instituted a broad range of changes to FDA policy, including evidentiary

SUBMITTER: Mitchell AP 

PROVIDER: S-EPMC8917050 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature