Dec
27
2010
The U.S. Food and Drug Administration (FDA) announced this week that it is seeking input on ways to address unapproved animal drugs. According to the agency, the term “unapproved animal drugs” refers to “animal drugs illegally marketed in the United States that have not been approved by the FDA. Unapproved animal drugs have not been reviewed under FDAs approval process.”

The FDA published a notice in the Federal Register, the official daily publication for rules, proposed rules, and notices of Federal agencies. In the notice, the FDA requests comments on two issues:

- ways to increase the number of legally marketed animal drugs

- the use of "limited enforcement discretion"

In regards to the first item, the FDA wants to discover ways in which it can make more drugs available legally to veterinarians and pet owners. According to the notice, the agency is willing to consider avenues not only within its existing regulatory framework, but also new ideas on how to make certain drugs legally available. Some of these novel methods might include creating animal drug monographs, or reviewing publicly available literature and data on some drugs.

According to the FDA, “enforcement discretion” is “a decision on the part of the Agency to not take enforcement action in certain circumstances.” Enforcement discretion is used in certain cases in order to ensure the availability of key animal drugs, even though they are not technically approved. In other words, they will not shut down a company for selling an unapproved drug if that drug is essential to an animal’s health.

The FDA wants to know: “What factors should the Agency consider when determining which unapproved animal drug products or categories of products should be the subject of enforcement discretion?”

To leave a comment on the FDA’s notice, visit http://www.regulations.gov  and search for Docket No. FDA–2010–N–0528.

 

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