FDA seeks comments regarding marketing of unapproved veterinary products

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Dec 20, 2010
By dvm360.com staff
Rockville, Md. -- The Food and Drug Administration (FDA) wants to identify strategies to address the number of animal drug products marketed without agency approval.

In a Federal Register notice published today, FDA says, "Our focus at this time is not on revising the current new animal drug approval process. Instead, we wish to explore additional mechanisms that utilize FDA's existing regulatory framework as well as novel strategies not currently employed by the agency to increase the number of approved or otherwise legally marketed animal drugs."

The agency's concern is focused on injectable vitamins, various topical shampoos and liniments, electrolyte and glucose solutions and antidotes, as well as a variety of anti-infectives.

"Given the broad array of animal drug products that are important for meeting the health needs of a diverse number of animal species, FDA is interested in exploring alternative approaches (i.e., alternatives to the existing new animal drug approval process) by which those products could be legally marketed," the agency says in the Federal Register notice.

Under limited circumstances, FDA says it will exercise "enforcement discretion" to allow access to unapproved animal drugs while drug companies work to get these drugs approved. This enforcement discretion means the agency "decides not to strictly enforce the requirements of the Federal Food, Drug and Cosmetic Act.