FDA scrutinizing extralabel and feed drug use

Hoard's Dairyman: 

FDA scrutinizing extralabel and feed drug use

Date: 
Fri, 04/06/2012

Big changes and much stricter rules are looking very likely.

by Hoard's Dairyman staff

Enormous change appears to be coming in the way dairies and other livestock operations are accustomed to using pharmaceuticals on their animals, says Christine Hoang, D.V.M. and Assistant Director of the Scientific Activities Division of the American Veterinary Medical Association.

Much stricter laws about the use of cephalosporins, including any use not stated on the label and any use for disease prevention, go into effect today (April 6). Longer term, she says the Food and Drug Administration is considering much tougher laws about extralabel use of antimicrobials in general, and their subtherapeutic use in feeds in particular.

Subtherapeutic use in feeds is definitely in FDA’s crosshairs. She says it has even come up with a new term for the practice: “production uses.” This alone is a strong suggestion that FDA wants to ban the practice. Why? Because antibiotics are only authorized for treatment of a diagnosed condition, not for enhancement of production efficiency.

An ‘umbrella’ issue over all of these is the profoundly more serious, more thoroughly documented, farther-reaching, more time consuming, and more restrictive Veterinarian-Client-Patient Relationship (VCPR) that FDA wants to see. Higher cost of such relationships would seem inevitable for producers whose veterinarians choose to keep them as clients.

Hoang says FDA is paying great attention to one of the legal requirements of VCPRs as they apply to drug prescriptions and proper drug use: “Such a relationship can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.”

Dramatic changes in how dairies and other farms use pharmaceuticals on their animals seems likely if FDA gets its way – which it usually does.


The next webinar is on Monday, April 9. “Choosing feed additives wisely” will review trends in feed additive selection in the U.S. The criteria to use when selecting an additive, ranking of common feed additives, and strategies when to use or not to use various feed additives will be discussed. This April webinar will be hosted and presented by Mike Hutjens, University of Illinois and brought to you by Elanco and their portfolio of dairy products. Learn more at www.hoards.com/webinars.

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