Jim McKean While Congress presently has bigger fish to fry, you can bet that antibiotic use in animals still is on the minds of some legislators, and the pork industry will continue to see challenges regarding antibiotics in the future.
Jim McKean, swineExtension veterinarian at Iowa State University, told producers that over their lifetime, they would likely see limitations on labeled usages, prescription control for over-the-counter (OTC) products, constriction of extra-label use (direct and indirect), more specific residue detection and subsequent action to violators.
Animal drug classifications
“There are two legal uses of drugs in the United States,” points out McKean.“There is labeled use (with NADA limitations) and there is extra-label use, which is under veterinary script. In other words, the veterinarian must be involved in the operation and the producer must accept what the veterinarian tells him to do. All other use of antibiotics is illegal – think about that and factor in its implications.”
McKean explains Guidance 209, which is now official,outlines FDA public health concerns, summarizes key scientific reports and outlines recommendations for “judicious” use in food-producing animals. “Its recommendations are not legally binding,” he says.“It is a discussion document but it does indicate future actions, and the recommendations refer specifically to food-producing animals.”
Producers should remember the term “medically important drugs,” which are drugs traditionally used as therapeutics in humans. According to McKean, Guidance 209 states medically important drugs should be limited to uses necessary for assuring animal health and should be used with veterinary oversight.
Guidelines for the approved use of these products include:
- Evidence of the drug’s effectiveness
- Consistency with accepted veterinary practices
- The drug’s use is linked to specific etiologic agent
- Its use is appropriately targeted
- There are no reasonable alternatives (i.e. other approved products)
Draft Guideline 213 has a voluntary phase-in over three years, which is to remove these medically important drugs from OTC use. Water-soluble medications will need a veterinary script for use and feed-based antibiotics will need a veterinary feed directive. Products will have new label indications/claims and will be directed for use to control a specific disease.