Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 90

In 1992, the Prescription Drug User Fee Act (PUFA) was passed and then renewed 5 years later in 1997 (PDUFA II), and again in 2002 (PDUFA III), 2007 (PDUFA IV), 2012 (PDUFA V), and 2017 (PDUFA VI). This Act allows the FDA to collect a fee from an applicant whenever the applicant submits an NDA or BLA. In addition, companies pay annual fees for each manufacturing establishment and for each prescription drug product approved for marketing. Previously, taxpayers alone paid for product reviews for regulatory action by the FDA, through congressional appropriations.

In the program authorized under PDUFA, industry provides the funding in exchange for FDA agreement to meet drug-review performance goals, which emphasize timeliness without a loss of scientific quality of the review. As examples, the PDUFA fee rate for FY 2018 was $2,421,495 for an application requiring review of clinical data and was $1,210,748 for an application not requiring review of clinical data. The fees are adjusted on an annual basis. The typical allowed review time for an NDA under PDUFA is 10-months (or 6-months for priority reviews). Questions have been raised about the appropriateness of what is, in effect, industry funding of the government process for approving a medical product for entry into the commercial marketplace. In reality, user fees are for application review, not approval. Approval is not guaranteed.