October 28, 2016

FDA to Tighten Labels and Marketing of Animal Antibiotics

Recently, an antibiotic-resistant superbug called MCR-1 has been found in two people and two pigs in the United States, and it was just found in the water in Rio de Janeiro. Brazilian scientists discovered a drug-resistant bacteria off the coast of one of the city’s beaches, one month before the Summer Olympics starts.

Antibiotic Pills

Giving antibiotics to food animals at sub-therapeutic doses is one way that these superbugs evolve. The MCR-1 resistance gene makes the last-line antibiotic colistin useless. The gene has been found in other bacteria in other countries. Since this gene can be transferred to other organisms, scientists are very worried.

So the FDA is planning to tighten labels and marketing options for antibiotics intended for animal use. That agency sent a letter to animal drug distributors, telling them that the marketing status of those antibiotics will change on January 1, 2017, from over-the-counter availability to a prescription or a veterinary feed directive (VFD).

The guidance document that heralded the move was issued in December 2013. The label on antibiotics can no longer state that the drugs can be used for growth promotion or feed efficiency. Unfortunately, they can still be used to prevent disease, which can be common in poor and crowded growing conditions. And guidance documents do not have the force of the law behind them. The document clearly states, “FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in FDA’s guidances means that something is suggested or recommended, but not required.”

The FDA did say in the letter that “all of the affected drug sponsors have committed to making the changes we requested. In some cases, drug sponsors may choose to withdraw a product approval completely. Distributors that are unable to meet the applicable State and Federal requirements for selling and distributing Rx and VFD animal drugs may no longer be able to sell these products once they have transitioned to the new marketing status.

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