Regulatory Brief

 AVMA Response to Risk Evaluation and Mitigation Strategies for Human-Labeled Drugs; Reopening of Comment Period


Formal title: Docket Number(s) [FDA-2010-N-0284 and FDA-2009-D-0461] Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period

The AVMA submitted comments regarding Risk Evaluation and Mitigation Strategies (REMS) as they pertain to animal health.

Brief Description:

The Food and Drug Administration (FDA) announced a two-day public meeting to obtain input on issues and challenges associated with the development and implementation of risk evaluation and mitigation strategies (REMS) for drugs and biological products. As FDA has taken steps to implement the REMS provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), some stakeholders have raised concerns about the impact of various REMS, and the growing number of REMS on the health care system, as well as on individual prescribers, pharmacists, distributors, and other affected stakeholders.

AVMA Response:

The AVMA applauds the FDA for its outreach to the public and stakeholders as the FDA considers how best to design and implement REMS. The AVMA would like to emphasize the critical need for veterinarians to continue having access to human-labeled drugs, in order to relieve animal pain and suffering and to protect animal health. Human-labeled drugs are utilized by veterinarians on a routine basis for the treatment of their animal patients. It is for this reason the extralabel use of human-labeled drugs in veterinary medicine became a legal, FDA-regulated activity that was codified by the Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994.

The risks associated with human drug use can be very different from the veterinary use of that same drug. For meaningful risk evaluation and mitigation, REMS should be appropriately designed based on anticipated applications and use scenarios. Therefore, the AVMA stresses the need to consider any possible unintended consequences from human-based REMS that could adversely impact the veterinarian's ability to protect the health and prevent suffering of animal patients.

Background Documents: