The Influence of the Prescription Drug User Fee Act on the Approval Process

The Prescription Drug User Fee Act (PDUFA) was originally enacted into law in 1992. PDUFA provides the Food and Drug Administration (FDA) with needed revenue in the form of various fees paid by drug and biologic manufacturers. The FDA utilizes this revenue to streamline the review and approval process for medications. Since the enactment of PDUFA, the median approval time for priority new drug applications and biologics license applications has reduced significantly. The FDA views PDUFA as a successful program that provides a consistent revenue stream to the agency, improves access to medications for patients, and allows industry to have a more predictable product review timeline. However, critics of PDUFA cite concerns including the potential for a lack of FDA independence and medication safety issues involving drugs approved after the existence of PDUFA.

Download Full-text

Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process

10.3386/w10822 ◽

2004 ◽

Cited By ~ 2

Author(s):

Ernst Berndt ◽

Adrian H. Gottschalk ◽

Tomas Philipson ◽

Matthew Strobeck

Keyword(s):

Prescription Drug ◽

Drug User ◽

Approval Process ◽

Fda Approval ◽

Prescription Drug User ◽

User Fee

Download Full-text

Recent Developments in Health Law: FDA and Drug Safety: New Tufts Study Challenges Critics of the Prescription Drug User Fee Act

The Journal of Law Medicine & Ethics ◽

10.1111/j.1748-720x.2006.00018.x ◽

2006 ◽

Vol 34 (1) ◽

pp. 131-134 ◽

Cited By ~ 1

Author(s):

Rochelle Lee

Keyword(s):

Prescription Drug ◽

Drug User ◽

Drug Testing ◽

Approval Process ◽

Prescription Drug User ◽

Recent Developments ◽

User Fee ◽

Public Scrutiny ◽

Approved Drugs ◽

Fda Approved Drugs

In the wake of several highly publicized lawsuits over drugs recalled for safety – most notably, Vioxx and Paxil – the Food and Drug Administration (FDA) and the pharmaceutical industry have faced increasingly intense public scrutiny over the drug testing and approval process. Critics blame the FDA's shorter pre-market approval process that has resulted from the enactment of the Prescription Drug User Fee Act (PDUFA), which effected, among other changes, an increased number of reviewers, a higher review load for each reviewer, and the implementation of “user fees” from companies submitting drugs for review. While many have posited that the lack of safety in some FDA-approved drugs was caused by the enactment of PDUFA, the results of a recent study from the Tufts Center for the Study of Drug Development have indicated that there is no statistically significant correlation between the number of drugs recalled for safety and the enactment of PDUFA.

Download Full-text