The report identified the primary cause for immediate drug shortages as manufacturer supply disruptions (i.e., when manufacturers halt or slow production to address quality problems). Drug shortages were also exacerbated by constrained manufacturing capacity that prevented manufacturers from being able to respond to a decrease in supply.
In addition, the GAO report noted that FDA needed to address inconsistencies with federal internal control standards, such as policies and procedures governing the management of drug shortages data. GAO also reported that FDA had not performed routine analyses using such data.
The GAO report is not entirely in alignment with FDA’s report to Congress on drug shortages, released on Feb. 5, and discrepancies exist between the two reports with regard to the number of ongoing drug shortages. GAO reported that ongoing drug shortages were growing, while FDA indicated that ongoing drug shortages were plateauing. GAO also commented that FDA did not have the policies in place to manage the shortage data it already collects in order to predict drug shortage risks. Notably, GAO concluded that FDA evaluated drug shortage data as a one-time occurrence, using data on an “ad hoc basis” rather than as a means to identify trends in predicting future drug shortages.
FDA is disputing certain aspects of the GAO report, namely, that the number of ongoing drug shortages is plateauing. FDA indicated that the discrepancy in ongoing drug shortage numbers may be due to a difference in how the Agency defines a drug shortage. HHS claims that GAO’s report identifying an increase in ongoing drug shortages may be incorrect because the GAO’s method does not account for manufacturers increasing production to meet demand when a competitor discontinues production of a drug.
To improve drug shortage data monitoring, FDA plans to develop a more comprehensive database of information to enhance tracking of potential drug shortages. FDA is also expected to work with manufacturers and other interested parties to identify ways to incentivize high-quality manufacturing that could help mitigate or prevent drug shortages.
To read GAO’s full drug shortages report, click here.
To read FDA’s full drug shortages report, click here.