A Legal Challenge of the Prescription Drug User Fee Act.

Abstract

In Part II, I present a legal challenge to the Prescription Drug User Fee Act (PDUFA) from an administrative law perspective. While I share sympathies with those who believe PDUFA represents an unacceptable conflict of interest for the FDA, I posit arguments purely from the framework of permissible administrative agency discretion so as to avoid ambivalent analytical and empirical arguments. My argument is that given the statutory and case law determinations of permissible federal agency discretion, the FDA cannot assess a flat user fee for widely variable types of services it renders during the drug approval process. Thus, the current implementation of PDUFA is legally impermissible. Subsequently, in Part III, I compare PDUFA to three other agency user-fee mechanisms and propose specific improvements to PDFUA to minimize its conflict of interest while maintaining its revenue efficiency.