May 15, 2007

 

 Policy on unapproved new animal drugs as devices passes - May 15, 2007

 

Policy on unapproved new animal drugs as devices passes
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The Executive Board approved a policy on unapproved new animal drugs marketed as devices, as defined by the Food and Drug Administration. The policy reads as follows:

Unapproved New Animal Drugs Marketed as Devices
The AVMA encourages the FDA to take greater enforcement action in regulating the marketing of products represented as devices as defined by the FDA to the veterinary profession but that appear to be unapproved new animal drugs.

The AVMA Council on Biologic and Therapeutic Agents submitted the recommendation. The council reported that some sponsors of approved human medical devices and some makers of veterinary medical devices are ascribing and promoting drug claims to their products. Because of this action, these products are concealed from animal drug safety and efficacy evaluations by the FDA. Marketers are given inappropriate competitive advantage over drugs that are approved by the administration for use in animals for the same indication.

The council also noted that this tactic hinders tracking of adverse effects associated with use of the products in animals, since there is no drug approval process within the FDA Center for Veterinary Medicine with which to reconcile the experiences.