Exhibit 1183 ยท Journal article
The Risk We Bear: The Effects of Review Speed and Industry User Fees on New Drug Safety
Results show that drugs receiving faster reviews are associated with increased counts of serious adverse drug reactions.
Examines drugs approved 1990-2001 and finds that faster reviews are associated with more serious adverse drug reactions, with controls for utilization, novelty and other factors. Abstract read (PubMed). Not the same author as Mancur Olson.
- Source
- Mary K. Olson, Journal of Health Economics 27(2):175-200
- Date
- March 2008
- Quoted from
- Abstract
- Grade
- Peer-reviewed
- Document
- https://doi.org/10.1016/j.jhealeco.2007.10.007
- Accessed
- 2026-11-10
- Cited by
- Findings citing this exhibit
- Note
- Standing note: opposite sign to Grabowski and Wang 2008 and Berndt et al. 2005 as reported by Lietzan (2024), who finds no association once novelty is controlled; the published record on PDUFA and safety is split.