案例库 · 法务与合规 · 法务决策 · 1992-1997
这条还没译成中文，下面是英文原文。
U.S. drug user fees paid the FDA to speed up its reviews
PDUFA had drugmakers pay FDA user fees for a promised review clock; standard and priority review times roughly halved.
U.S. Food and Drug Administration · Drug and biologic manufacturers
那一手
In the years before 1992 new drug applications sat at the FDA for well over two years while safety and efficacy review capacity lagged behind submissions.
The Prescription Drug User Fee Act, enacted in 1992, shifted part of the cost to the companies submitting applications and bound the FDA to explicit, published review-time goals.
Under PDUFA the agency committed to review 90% of standard applications within 12 months and 90% of priority applications within 6 months, targets tightened over successive reauthorizations.
为什么管用
- User fees let the FDA hire reviewers to match the workload, not a flat congressional appropriation.
- A published performance goal made the promised turnaround a measurable commitment the public could check.
- The fee was tied to the application a company sent, so those who benefited paid in proportion to what they used.
- Priority applications got a faster lane, so truly urgent medicines were not queued behind routine ones.
可以搬走什么
When a public service is bottlenecked on resources, charging the parties who benefit and tying that money to a measurable service target can fix both at once.
后来呢
Median NDA and BLA review times fell roughly by half over the program's first reauthorizations, and standard review goals tightened to about 10 months; the user-fee model was later extended to devices, generics and biosimilars.
资料来源
- PDUFA at a Glance - Enabling Innovation and Timely Access to New Treatments
- FDA-TRACK: Prescription Drug User Fee Act (PDUFA) Performance Reports
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