The current state of drug shortages in the supply chain is under continued pressure, both outside of and within the U.S. According to the FDA, there are currently 105 products in shortage in the U.S. (here) as of the drafting of this blog. Not only are the shortages continuing, but adherence to section 506C of the U.S. Food, Drug, and Cosmetic Act, which requires notification to the FDA in cases of temporary or permanent interruption to the U.S. market (Drug Shortages: Non-Compliance With Notification Requirement | FDA), is also coming under scrutiny. Congress had recently requested an update to an earlier request for data on the foreign inspection program (Committee on Energy and Commerce to FDA 13Dec2023). In this letter, Congress asks the FDA to, “Provide a list of all foreign facilities that have been penalized for noncompliance” (regarding CARES Act reporting requirements mentioned above).
Meanwhile, the U.S. Department of Health and Human Services issued a white paper titled “Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States.” Some of the paper’s highlights are:
- Establishing a new agency role called “Supply Chain Resilience and Shortage Coordinator.”
- Quality Management Maturity, which is described as to:
- “…help gauge adoption of management practices that support a more reliable drug supply chain by reducing the occurrence of quality-related failures…”
- In addition, a final guidance on “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act” was issued by the FDA in February 2024.
Many of these initiatives are backed up by collective industry and academic efforts, for example the Duke-Margolis ReVAMP Drug Supply Chain Consortium, of which Lachman Consultants is a proud founding member and part of the advisory committee.
However, with all this political and legal landscape movement, the biggest challenge for companies is understanding the complex end-to-end global supply chains for drug products that have evolved. Lachman Consultants can provide services to help companies understand and manage the risks associated with meeting the draft requirements in “Risk Management Plans to Mitigate the Potential for Drug Shortages,” which can utilize emerging trends in data governance, lead indicators, and risk management.
Want to understand the risks in your supply chain? Lachman can help! Reach out to us to schedule a consultation at LCS@LachmanConsultants.com, or visit our contact page (here).
