Hospital Pharmacy - April 2018 - 88

757519
research-article2018

HPXXXX10.1177/0018578718757519Hospital PharmacyGabay

Rx Legal

The Prescription Drug User Fee Act:
Cause for Concern?

Hospital Pharmacy
2018, Vol. 53(2) 88-89
© The Author(s) 2018
Reprints and permissions:
sagepub.com/journalsPermissions.nav
https://doi.org/10.1177/0018578718757519
DOI: 10.1177/0018578718757519
journals.sagepub.com/home/hpx

Michael Gabay1

Abstract
The Prescription Drug User Fee Act (PDUFA) was originally enacted into law in 1992.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.
Keywords
medication safety, legal aspects, ethics
President George Bush signed the initial Prescription Drug
User Fee Act (PDUFA) into law in 1992.1,2 Since its initial
enactment, PDUFA has been reauthorized several times with
the most recent authorization occurring in 2017.3 Under
PDUFA, the Food and Drug Administration (FDA) collects
various fees (ie, application, establishment, and product fees)
from pharmaceutical and biologic manufacturers.1 The FDA
then uses these funds to hire more necessary staff, upgrade
data systems, provide pharmaceutical industry guidance
regarding ways to enhance drug development, and improve
procedures and standards to make reviews of drugs and biologics more "rigorous, consistent, and predictable."4
Traditionally, the pharmaceutical industry adamantly
opposed the adoption of user fees by the FDA.2 However, the
industry's viewpoint shifted when it became apparent that
the fees would actually benefit the pharmaceutical industry
financially due to a significant reduction in the time to review
new drug applications (NDAs). Historically, the FDA review
process was extensively prolonged; therefore, even a reduction of 1 month in the process could significantly reduce the
costs of an NDA by more than the user fee. With the enactment of PDUFA, the FDA significantly improved the median
approval time for priority NDAs and biologics license applications; the median time was 13.2 months in 1993 compared
with 6.4 months in 2003.4 In addition, more than 1000 new
drugs and approximately 100 new biologics were approved
since the initial passage of PDUFA with 50% of these new
drugs initially marketed in the United States, compared with
only 8% in the years prior to PDUFA.

The FDA views PDUFA as a successful program as the
agency has a consistent revenue stream for needed resources,
the public receives access to medications in a more rapid
fashion, and the pharmaceutical industry has a more predictable product review timeline.2 However, critics of PDUFA
note that its existence may potentially undermine public trust
in the FDA. These individuals question whether the FDA can
truly be independent and provide appropriate review of medications and biologics when industry money finances a significant proportion of its budget; the FDA has collected $7.67
billion in user fees from the industry since 1992.5 Others
point to postapproval medication safety issues and suggest
that the Act may play a role in exposing patients to medications with significant safety concerns due to the "pressure" to
approve new drugs and biologics prior to a PDUFA deadline.2
Frank and colleagues reported that drugs approved by the
FDA after the passage of PDUFA were more likely to be withdrawn from the market or receive a black box warning than
medications approved prior to its enactment (26.7 per 100
drugs vs 21.2 per 100 drugs at up to 16 years of follow-up).6
Another analysis by Carpenter and colleagues found that
PDUFA requirements "concentrated the number of approval
decisions made in the weeks immediately preceding" PDUFA
1

The University of Illinois at Chicago, IL, USA

Corresponding Author:
Michael Gabay, College of Pharmacy, The University of Illinois at Chicago,
833 South Wood Street, Chicago, IL 60612, USA.
Email: mgabay@uic.edu
https://us.sagepub.com/en-us/journals-permissions http://journals.sagepub.com/home/hpx
Table of Contents for the Digital Edition of Hospital Pharmacy - April 2018
