Working off recent publications showing the majority of drug shortages trace to quality issues, the U.S. Food & Drug Administration has drafted guidelines to help U.S. healthcare better prepare for and respond to events associated with these situations.
Along with offering a framework to help stakeholders align risk-management plans (RMPs) with principles laid out in 2006 guidance from the International Council for Harmonisation, the May draft lists key risk factors for RMP developers to consider.
For primary stakeholders—defined as entities that determine which materials and services are necessary to produce a drug product—the document flags a handful of risk types deserving concerted attention. These include:
- Geographic risk factors, including potential for natural disasters, as well as political instability and regulatory uncertainty, that can affect the overall ability to consistently manufacture a drug
- Supply chain vulnerabilities, such as sole source manufacturers of critical components in a drug product, including active pharmaceutical ingredient, and sole source manufacturers of a drug product
- Manufacturing vulnerabilities, including lack of manufacturing capacity to meet an unexpected surge in demand, inadequate backup manufacturing capability, lack of availability of contract manufacturers or other alternate sources, lack of availability of laboratory services to support manufacturing, and inadequacy of management oversight
- Distribution vulnerabilities, including the complexity of distribution or transportation of components, drug product containers and closures, and drug products
- Cybersecurity threats to equipment or systems used in manufacturing or distribution
- Emergency situations that reduce staff or facility availability to continue manufacturing
The agency also includes information aimed at secondary stakeholders—entities that are expected to “have more detailed insight into specific segments of the supply chain for a drug product but may not have an understanding of its entirety”—as well as other stakeholders, e.g, inactive ingredient manufacturers, packagers and distributors.
The 21-page document [1], posted May 20, is open for comments until July 19.
FDA has placed links to download the draft guidance document, read the related Federal Register notice and submit contents on an introductory webpage.
Reference:
- “Risk Management Plans to Mitigate the Potential for Drug Shortages.” U.S. Food & Drug Administration, Center for Drug Evaluation and Research, May 2022. Docket Number: FDA-2022-D-0277
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.