Prescription Drug User Fees -- Overview
In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA). This was reauthorized by the Food and Drug Modernization Act of 1997 and again by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. PDUFA authorized FDA to collect fees from companies that produce certain human drug and biological products. Any time a company wants the FDA to approve a new drug or biologic prior to marketing, it must submit an application along with a fee to support the review process. In addition, companies pay annual fees for each manufacturing establishment and for each prescription drug product marketed. Previously, taxpayers alone paid for product reviews through budgets provided by Congress. In the new program, industry provides the funding in exchange for FDA agreement to meet drug-review performance goals, which emphasize timeliness.