P310: Drug Shortages Final Rule Retrospective Analysis
Poster Presenter
Katherine Toran
Economist
FDA United States
Objectives
We present findings from a retrospective analysis of FDA’s Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products Final Rule, published in 2015.
Method
This rule requires all applicants of covered drugs or biologics, and all manufacturers of covered prescription drugs marketed without an approved application, to notify FDA of an interruption in manufacturing that would lead to a meaningful disruption in supply six months in advance (or as soon as practicable) of the interruption. FDA is statutorily required to submit an annual report to Congress on drug shortages. The format and content of these annual reports have been standardized at least over the years 2012 through 2023. This facilitates analyses of the numbers of notifications, potential and averted shortages, and actions taken by FDA and industry to avert shortages over time.
Results
Following implementation of the rule, the number of notifications increased more dramatically than the prospective analysis predicted.
Conclusion
The steep increase in notifications is the overwhelming determinant of the increases in costs and cost savings of the rule. The RIA estimated benefits of the rule to be $1.4-5.8 million per year. Our updated analysis estimates benefits to be $7.0-112.1 million per year. The upward trend in notifications does not appear to be slowing even ten years after the rule. This has implications for the choice of time horizon in regulatory impact analyses.
