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FDA already taking questions about antibiotics use changes
 
FDA already taking questions about antibiotics use changes

By MICHELE F. MIHALJEVICH
Indiana Correspondent

ARLINGTON, Va. — The implementation of changes to the Veterinary Feed Directive (VFD) is two years away, but questions about the new system are keeping officials with the America Feed Industry Assoc. (AFIA) busy.
Recommendations regarding use of antibiotics in production animals have been developed by the U.S. Food and Drug Administration (FDA) and will be implemented beginning December 2016.
Under the agency’s directive, drug companies will be required to change label-use conditions to remove the use of antimicrobial drugs for production, or growth, purposes, according to the FDA. Labels will be modified to indicate only therapeutic use for the drugs.
Another change will allow for veterinary oversight or consultation by revising the marketing status from over-the-counter to prescription.
Therapeutic use is defined as to cure, treat, prevent or mitigate a disease, said Richard Sellers, AFIA senior vice president for legislative and regulatory affairs.
“(Our members) have questions, such as how is this going to roll out,” he said. “They want to know how in the hell this is going to work.”
One concern is that all the changes are supposed to take effect on the same day, Sellers noted. Another is regarding the proper training for veterinarians unfamiliar with livestock medicine who may opt to begin writing VFD-related prescriptions.
The changes are being made because of increased resistance to antibiotics in humans and animals, the FDA stated. “They’re looking for more of a judicious use of these drugs,” Sellers explained. “Too many animals are transferring resistance to humans through the meat we eat. The issue really isn’t safety, but that long-term judicious use.”
The annual impact of human antibiotic-resistant infections on the nation’s economy may be as high as $20 billion in health care costs and $35 billion in lost productivity, according to a September report from the President’s Council of Advisors on Science and Technology. Such infections are associated with 23,000 deaths and 2 million illnesses yearly, the report said, adding the problem is worsening.
Under the new VFD format, a producer seeking a drug for animals with a health problem will first need to contact a veterinarian. The vet will confirm the need for a VFD drug and give the producer a form to take to the feed company. The feed company will mix the drug with feed and ship it to the producer.
There are currently two approved animal drugs – with five uses – for pigs, cattle and fish, according to AFIA. The VFD was created as a part of the Animal Drug Availability Act of 1996.
Mixing drugs in feed is the most efficient way to get the medicine to the animals, Sellers said. Depending on such things as the availability of the drug needed and the distance from the feed company to the producer, the drugs should be in the hands of the producer within 48 hours, he noted.
“There’s going to be a massive amount of paperwork,” Sellers stated. “It’s going to be a nightmare to implement.”
The FDA has a target date of April 2015 to publish the final rules for the directive. President Obama has called antibiotic resistance in humans and animals a national security priority.
12/17/2014