FDA proposes three solutions to mitigate drug shortages

The US Food and Drug Administration (FDA) has released a report that analyses the root causes of drug shortages and recommends solutions.

The ‘Drug Shortages: Root Causes and Potential Solutions’ report identifies three reasons that drug shortages can occur:

1. A lack of incentives for manufacturers to produce less profitable drugs
2. Limited recognition for manufacturers with ‘mature quality systems’ that focus on continuous improvement and early detection of supply chain issues
3. Logistical and regulatory challenges that make it difficult for the market to recover from a shortage.

Some resolutions offered by the FDA include developing a system to incentivise drug manufacturers to invest in quality management maturity for their facilities. Another is to promote sustainable contracting approaches to ensure a reliable supply of drugs. Creating a shared understanding of the impact that shortages can have on patient care is a final suggestion from the FDA.

The legislative proposals that the FDA presents to prevent and ease drug shortages include improved data sharing, risk management, lengthened expiration dates for medications and internationally harmonised guidelines for a pharmaceutical quality system.

Acting FDA Commissioner Ned Sharpless and FDA Director of the Center for Drug Evaluation and Research Janet Woodcock said in a statement: “The root causes of shortages involve economic factors that are driven by both private- and public-sector decision-making. This means that the types of enduring solutions proposed in the report will require multi-stakeholder efforts and rethinking business practices throughout all sectors of the health care system.”