Changes Sought in Drug Shortage Draft Guidance

Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance on risk management plans to mitigate the potential for drug shortages “would benefit from a number of changes to enhance clarity for stakeholders developing and implementing risk management plans to mitigate drug shortages.” The comment letter makes eight specific recommendations for changes. It concludes that the draft “largely complements ongoing industry efforts to mitigate risk by having continuity plans in place to address supply chain or other disruptions. We believe the draft guidance can be enhanced through our changes….”

The Biotechnology Innovation Organization (BIO) says that while it generally agrees with the systematic approach for establishing risk management plans laid out in the draft guidance, “we have serious concerns related to the scope and timing of the guideline….” The letter raises six major concerns and also has a table with line-by-line comments.