FDA Set to Change Status of Antimicrobial Drugs

USAgNet - 01/19/2023

University Products LLC recently alerted cattle ranchers to an official move by the FDA that will soon make it much harder to access antimicrobial drugs. The Center for Veterinary Medicine's (CVM) Guidance for Industry #263 goes into effect on June 12, 2023. The guidance applies to all food animals and animals not intended for food, and includes penicillin, sulfa-based drugs, boluses, intramammary mastitis tubes, and topical products. For decades, antimicrobials were used to treat seasonal diseases like anaplasmosis in cattle, but there are better options - like vaccines produced by University Products.

Additionally, as of February 21, 2023, the FDA will again hold veterinarians to federal requirements for a veterinarian-client-patient relationship which "requires animal examination and/or medically appropriate and timely visits to the premises where the animal(s) are kept." These requirements, temporarily put aside for the COVID-19 pandemic, can no longer "be met solely through telemedicine."

"In the past, before the FDA tightened antibiotic restrictions, ranchers treated anaplasmosis infections indiscriminately with an oxytetracycline or chlortetracycline supplied in feed and mineral supplements," said Dr. Donald Luther, University Products vaccine developer. "All of these treatments required a Veterinary Feed Directive (VFD). But even without restrictions, what decades of using these medicines have shown us is this: most cows do not eat enough feed for an effective dose and ultimately spread anaplasmosis to the herd anyway."

"It is difficult to know which cows have been infected and which cows are not until it is too late. And research has also found that this treatment is scattershot at best when used for anaplasmosis. But even worse, it has extremely harmful effects overall. Constant antibiotic use produces antimicrobial-resistant 'super bugs' that are almost completely immune to these medicines. So eventually, the whole cycle becomes a waste of time and money, while also breeding far more dangerous variations of illness. Frankly, the only effective treatment that makes sense anymore is vaccination."

Louisiana-based University Products produces the only clinically tested and effective vaccine against anaplasmosis that is approved for experimental use and has been successfully deployed in the U.S., Puerto Rico, and South America for over two decades.

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