Regulatory Brief

 Product Shortage Report


Formal Title:

Docket Number [FDA-2011-N-0690] Product Shortage Report; Availability; Request for Comments

Brief Description:

The FDA is announcing the availability of a medical product shortage report entitled “A Review of FDA’s Approach to Medical Product Shortages.” The report discusses the Agency’s approach to product shortages, particularly those products regulated by the FDA Center for Drug Evaluation and Research (CDER).

AVMA Response:

The AVMA commends the FDA on pursuing a means to mitigate drug product shortages in the United States. Drug Shortages affect people as well as animals. Without the availability of these drug products, the health of people and animals will suffer. Veterinarians depend on the availability of animal drugs as well as human drugs used in an FDA-regulated extralabel manner.

The AVMA is committed to the continued availability of medical products that are pure, safe, potent and efficacious for animals. We offer the following current thinking on FDA’s report and its plan for mitigating drug shortages:

  • Because there are a limited number of drugs labeled for use in animals, veterinarians need to have access to human-labeled prescription drugs to effectively treat patients,
  • Although the AVMA believes compounding from bulk active ingredients might be warranted in limited circumstances for non-food animals, we value FDA-approved drugs because we can be assured of efficacy, safety, potency, and consistency across batches of drugs for use in patients,
  • The AVMA is willing to provide clinical subject matter expertise to the CVM regarding how to best manage various shortages when encountered,
  • More frequent FDA-industry cross-communication regarding pending and current drug shortages, as well as possible mitigation strategies to such shortages, is encouraged,
  • The AVMA is willing to provide clinical subject matter expertise to the CVM regarding how to best manage various shortages when encountered.

Background Documents: 

Related AVMA policies: