Exhibit 1182 ยท Journal article
Drug-Review Deadlines and Safety Problems
As compared with drugs approved at other times, drugs approved in the 2 months before their PDUFA deadlines were more likely to be withdrawn for safety reasons (odds ratio, 5.5; 95% confidence interval [CI], 1.3 to 27.8)
Using new molecular entities approved from 1950 to 2005, the authors find that PDUFA deadlines concentrated approvals just before the deadline and that drugs approved in the two months before a deadline were more likely to be withdrawn, get a boxed warning or have a dosage form discontinued. The test is about deadlines in a fee-funded program, not fee source. FDA authors published a critical letter (Nardinelli, Lanthier and Temple, N Engl J Med 2008;359:95-6); the letter text was not read. Abstract read (PubMed).
- Source
- Carpenter, Zucker and Avorn, New England Journal of Medicine 358(13):1354-1361
- Date
- 27 March 2008
- Quoted from
- Abstract, Results
- Grade
- Peer-reviewed
- Document
- https://doi.org/10.1056/NEJMsa0706341
- Accessed
- 2026-11-10
- Cited by
- Findings citing this exhibit
- Note
- Standing note: wide confidence intervals (small number of events); disputed by FDA staff. It tests the deadline, which is a performance term negotiated with the fee payers, not the funding source. Do not cite it as showing that user fees cause unsafe approvals.