FDA wants public comment on anesthetics for companion animals (US)

Written By JADED MARE

Oh, look. The FDA thinks horses are companion animals. That's cos they want to sell drugs that will make them dead sleepy so humans can make operations on them and other handy things to make lots of money.

Hey, Mr. Horse are you awake? Huh? I can't hear ya. Wait a minute. Here's a handy captive bolt that will knock you out if the gas didn't get ya. Works every time at the slaughter -- I mean, processing -- factory . . . well, sometimes. Sorry, this might hurt a little bit.

The FDA right this minute thinks that horses are companion animals.

Of course, we don’t kill companion animals, except all the time, but not to eat later unless you are a horse because foreigners in other countries think horse flesh tastes real yummy, especially American brand.

Hmmm. Would these drugs fall into the category of not to be used on animals for human consumption? Oh, suppose they forgot or something; they don’t say or who makes the stuff. Not that it seems to matter, also. You could ask Germaine, but she’s probably not telling or just don’t know, it’s not her job or something to think about those things.

On December 17, 2008, the Food and Drug Administration (FDA) published in the Federal Register the availability of a draft guidance document for industry entitled “Guidance for Industry #192: Anesthetics for Companion Animals.” The comment period for the guidance closes on March 2, 2009.

The purpose of the guidance document is to provide industry with FDA’s recommendations for the development of new animal anesthetic drug products for companion animals (dogs, cats, and horses.) (emphasis added)

The guidance discusses information that sponsors should consider when planning and conducting safety and field studies for their proposed drug product. The guidance also provides recommendations on how to analyze the study data and how to present the collected data in an organized package to CVM.

The draft guidance, once finalized, will represent the Agency’s current thinking on the development of companion animal general anesthetic (injectable or inhalational) drug products.

The draft guidance document is available at http://www.fda.gov/cvm/Guidance/guide192.pdf. The federal register notice can be found at: http://edocket.access.gpo.gov/2008/E8-29953.htm.

Interested persons may submit written comments on or before March 2, 2009, to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted to: http://www.regulations.gov/. Identify all submissions to the docket with the following docket number: 2008D-0623.

For additional information about the draft guidance, please contact Dr. Germaine Connolly at FDA’s Center for Veterinary Medicine, 240-276-8331, germaine.connolly@fda.hhs.gov.