Hospital Pharmacy - April 2018 - 89

Gabay
deadlines.7 Medications approved by the FDA within 2
months prior to their PDUFA deadlines were significantly
more likely to be withdrawn from the market for safety reasons, carry a subsequent black box warning, and have 1 or
more dosage forms voluntarily discontinued by the manufacturer. Although the results from these analyses may be a reason for concern, they do not definitively establish a causal
relationship between aspects of PDUFA and an increased risk
to patients.
In summary, PDUFA remains a cornerstone of the current
FDA drug review process, particularly because Congress has
shown no interest in increasing direct appropriations to the
agency. The fees generated by PDUFA have allowed the
FDA to hire more staff, significantly improve review times
for drugs and biologics, and enhance access to needed therapies for patients. However, critics of PDUFA wonder whether
the FDA can truly be independent when the pharmaceutical
industry funds a significant portion of its budget and point to
data implying an association between PDUFA deadlines and
an increase in medication safety concerns.

References
1.

Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect
to the research, authorship, and/or publication of this article.

Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.

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Food & Drug Administration. White paper Prescription Drug
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fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/
ucm119253.htm. Published May 3, 2010. Accessed January
13, 2018.
Wollett F, Jackson J. FDA has received $7.67 billion from
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2016. Accessed January 13, 2018.
Frank C, Himmelstein DU, Woolhandler S, et al. Era of faster
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