Sole suppliers that outsource manufacture must alert the FDA of interruptions at their CMOs, the Agency wrote in draft drug shortages guidance.
Companies that are the sole manufacturers of certain biopharmaceuticals must tell the US Food and Drug Administration (FDA) about supply interruptions that could lead to shortages. Outsourcing the work to a CMO (contract manufacturing organisation) is no excuse for failing to tell the FDA.
“The interim final report makes clear that it is the application holder of the drug product subject to section 506C who bears the responsibility for reporting a discontinuance to the Agency”, the FDA wrote in its drug shortages draft guidance.
An application holder is considered “sole manufacturer” even if it outsources production of the drug to a third party. In these cases the FDA wants application holders to make pathways for their CMOs to tell them about any disruptions to supply.
Quality shortcomings at CMOs, primarily Ben Venue Laboratories, have led to drug shortages. The FDA guidance aims to limit the impact of CMOs suspending production but there are some who think it is best to avoid the problem entirely by keeping manufacturing in-house.
“APP believes that in-house manufacturing is a more reliable way to supply the market than a virtual supply chain based on overseas third-party production facilities”, Mitchell Ehrlich, vice president of quality assurance at APP Pharmaceuticals, said at a FDA press conference last week.
The FDA drug shortages team speaks often with APP, Ehrlich said, and this allows the company to step in and help fix emerging problems, such as the lack of preservative-free methotrexate. APP will begin shipping the product in March after the FDA expedited the review process.
Ehrlich said keeping production in-house allows APP to respond quickly to shortages. In these cases APP expedites raw material orders, Ehrlich said, and quickly arranges extra manufacturing capacity.