Regulatory Brief

 Veterinary Medicine Advisory Committee; Notice of Meeting


Formal title: Docket Number [FDA-2010-N-0001] Veterinary Medicine Advisory Committee; Notice of Meeting


Brief Description:

The Department of Health and Human Services (DHHS) announced a forthcoming meeting of a public advisory committee (specifically the Veterinary Medicine Advisory Committee) of the Food and Drug Administration (FDA). The purpose of the meeting is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

AVMA Response:

The AVMA applauds the FDA for its continued efforts to ensure the safety of drugs used by veterinarians to relieve animal pain and suffering. The AVMA appreciates the FDA's current Risk Minimization Action Plan (RiskMap) program, which was developed initially to provide availability of an injectable heartworm preventative while incorporating ways to increase the safety of administration. While the intent is laudable, the AVMA cautions against the unintended consequences that could result from restricted availability of drugs approved by the FDA. The AVMA's comments are not directed toward any one product in particular, but rather, the adverse events reporting system in general and resulting Risk Evaluation and Mitigation Strategies' (REMS) ramifications on veterinary drug access.

The AVMA appreciates the FDA's provision for continued availability of FDA-approved products through novel approaches such as the current RiskMap program. The AVMA also appreciates the opportunity to share its perspectives on the RiskMap process in particular, to relay both positive comments and concerns regarding the FDA's adverse event reporting system, and to acknowledge the VMAC's expertise and benefits of open discussion at VMAC meetings.

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