The Food and Drug Administration (FDA) has issued a report assembled by the inter-agency Drug Shortages Task Force to determine the root causes of drug shortages, and to offer recommendations based on the insights from stakeholders in the private and public sectors to help prevent future drug shortages.
The Task Force was assembled in response to a congressional request last year, and it consists of FDA economists and scientists who analyzed drugs that went into shortage from 2013 to 2017.
The report identified 3 root causes for drug shortages:
- Manufacturers are not inclined to produce less profitable drugs;
- Limited recognition for manufacturers with “mature quality systems” that focus on continuous improvement and early detection of supply chain issues;
- Logistical and regulatory challenges that make it difficult for the market to recover from a shortage
In a press statement, the FDA noted that “The root causes of shortages involve economic factors that are driven by both private- and public-sector decision-making… and “that the types of enduring solutions proposed in the report will require multi-stakeholder efforts and rethinking business practices throughout all sectors of the healthcare system.”
The report offers 3 recommendations to help prevent and mitigate drug shortages:
- Increase understanding of the impact of shortages and the companies’ contracting practices that contribute to them;
- Develop a system to measure and rate a facility’s quality management maturity to ensure the delivery of reliable high-quality products;
- Promote new contracting approaches that help ensure a reliable supply of drugs
Moreover, the report explains legislative approaches and planned FDA initiatives to prevent future drug shortages, including new requests in the President’s FY 2020 budget and new guidelines that will be released by the end of calendar year 2019.
In addition, the FDA also believes the issue of drug shortages requires international action. The International Council for Harmonisation (ICH) is finalizing a guideline, ICH Guideline Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, that will assist and facilitate manufacturers in the international market to avoid potential disruptions and modernize their processes and equipment.
For more information visit fda.gov.