A new report on the underlying factors responsible for drug shortages, and the potential solutions, has been published by a United States (US) Food and Drug Administration (FDA) task force.
The report is based on information from stakeholders, published research and economic analysis of the market conditions impacting drug shortages.
Three root causes of drug shortages have been identified:
- Lack of incentives for manufacturers to produce less profitable drugs;
- The market does not recognize and reward manufacturers for “mature quality systems” that focus on continuous improvement and early detection of supply chain issues; and
- Logistical and regulatory challenges make it difficult for the market to recover from a disruption.
The report has also recommended three enduring solutions to tackle these problems, which include:
- Creating a shared understanding of the impact of drug shortages on patients and the contracting practices that may contribute to shortages;
- Promoting sustainable private sector contracts (e.g., with payers, purchasers, and group purchasing organizations) to make sure there is a reliable supply of medically important drugs; and
- Developing a rating system to incentivise drug manufacturers to invest in quality management maturity for their facilities.
The rating system has been proposed because many manufacturing sites have only focused their efforts on the minimum threshold of good manufacturing practice (GMP). Companies currently have no obligation for “more advanced levels of quality management, which aim to robustly detect vulnerabilities and address them in order to prevent the occurrence of problems, nor do they establish a culture that rewards process and system improvements”.
Older drugs, mainly generics, are especially short on the market. The report states that this is partly due to the fact that the market does not provide incentives for manufacturers to invest in the latest technologies and improvements in quality management. Even if such manufacturing investments are made, it can be challenging to identify measures of quality that could predict operating outcomes such as suspension of manufacturing lines that cause supply disruption.
The rating system would need to provide clear, concise and objective information about the maturity of a manufacturing site’s quality management. The FDA has re-iterated that by creating a quality rating system, buyers will “recognise and reward manufacturing quality maturity”.
Additionally, the report describes legislative proposals and planned FDA initiatives to prevent and mitigate shortages such as improved data sharing, risk management, lengthened expiration dates for drugs, and internationally harmonized guidelines for a pharmaceutical quality system.
To view the FDA’s report, click here.