APC: Califf positive on permanent urgent-use compounding fix

May 12, 2023

Califf positive on permanent urgent-use compounding fix

Responding to a question from Congresswoman Diana Harshbarger (TN) during a recent Energy & Commerce Health Subcommittee Hearing on “Preparing for and Responding to Future Public Health Security Threats,” FDA Commissioner Dr. Robert Califf acknowledged the importance of compounding for addressing drug shortages during emergencies.

He also indicated that a permanent solution or guidance on the flexibility of compounding pharmacies could be a good thing to work on.

Additionally, Rep. Harshbarger questioned whether the FDA’s shortage list accurately captures regional and wholesale level shortages. Dr. Califf agreed that the current system is subjective and could be improved, particularly in understanding the total distribution system. The possibility of recognizing the American Society of Health System pharmacist shortage listing was also raised, with Dr. Califf stating that everything is on the table for consideration.

We are very grateful to Rep. Harshbarger (who is also an APC member) for raising these issues for discussion.