The FDA-led Drug Shortage Task Force, which was formed at the urging of 31 U.S. Senators and 104 members of the U.S. House of Representatives in June of 2018, has released a report entitled Drug Shortages: Root Causes and Potential Solutions, examining the underlying influences responsible for the oftentimes critical drug shortages that have taken place in the U.S. over the last few years.
In an attempt to understand the factors contributing to drug shortages, the Drug Shortage Task Force commissioned a team of economists and scientists to analyze drugs that were into shortage between 2013 and 2017; public participation was also encouraged via public meetings and comments. Based on insights gathered from stakeholders in the public and private sectors, published research, and their own analysis, the task force then began to identify causes and offer recommendations.
The task force acknowledged three major root causes of drug shortages:
- Lack of incentives to produce less profitable drug
- Market does not recognize and reward manufacturers for mature quality management systems
- Logistical and regulatory challenges make it difficult for the market to recover after a disruption
Recommended remedies for continued shortages included creating a shared understanding of the impact of drug shortages and the contracting practices that may contribute to them, as well as creating a rating system to incentivize drug manufacturers to invest in achieving quality management system maturity.
To read the task force’s findings in full, click here.
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