Exhibit 1184 ยท Agency-commissioned report in a law review
User Fee Programs (report to the Administrative Conference of the United States, published in Administrative Law Review)
In this case, though, empirical studies have found that user fees do not affect the quality of drug approval decisions, at least when post-approval drug safety issues are used as a proxy for a poor quality approval decision.
Surveys user-fee programs across federal agencies and reports the empirical record on whether fees skew agency decisions: the Frakes-Wasserman USPTO finding of grant bias, and for FDA studies that find no effect on approval quality as measured by post-approval safety problems. Names Gilhooley as the main capture-side critic of FDA fees and cites Grabowski and Wang (2008) and Berndt et al. (2005) for the null; those two papers were not read here. Pages 406-408 read.
- Source
- Erika Lietzan, Administrative Law Review 76(2):375-
- Date
- 2024
- Quoted from
- Part II.A.6, p. 407
- Grade
- Primary record
- Document
- https://administrativelawreview.org/wp-content/uploads/sites/2/2024/06/ALR-76.2_Lietzan.pdf
- Accessed
- 2026-11-10
- Cited by
- Findings citing this exhibit
- Note
- Standing note: a careful legal review, not original empirics. Best single source for stating, without overclaiming, that the evidence on fee funding is mixed: one bias finding (USPTO), one leniency finding in banking (Kisin and Manela), and FDA safety nulls with dissent.