Stakeholders Want More Drug Shortage Mitigation Info

Bristol Myers Squibb (BMS) says that while it appreciates the framework in an FDA draft guidance on risk management plans to mitigate the potential for drug shortages, there are some aspects of the draft that are not clear concerning execution, FDA expectations, and overall processes used to mitigate drug shortages. The company comment letter asks whether the agency or the establishment will determine if a risk mitigation plan is required and asks that FDA provide an example of a risk mitigation plan template. BMS also wants to know who will review risk mitigation plans and whether the plans will be subject to routine surveillance and inspection. It poses several other questions and recommends the guidance be updated to align with the International Council for Harmonization’s Q9(R1) Quality Risk Management guidance document once finalized.

Specific technical comments were submitted by the Bulk Pharmaceuticals Task Force.