The U.S. Food and Drug Administration is now in the early stages of implementing a plan to curb, or phase out, if possible, the use of over-the-counter antimicrobial drugs used in livestock feed or water. These are used for the purposes of improving animals’ speed of growth and weight gain with less food.
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While faster growth and weight gain are side benefits of antimicrobial drugs, these are not their main functions. As the FDA explains, “Antimicrobial drugs include all drugs that work against a variety of microorganism, such as bacteria, virus, fungi, and parasites.” All antibiotics are antimicrobials that fight against bacteria.
According to the agency, the issue of concern is antimicrobial resistance. This occurs when bacteria or other microbes become resistant to the effects of a drug after being exposed to it.
Several antimicrobial drugs used in the animal industry are also used to treat human infections. This has also prompted concerns that overuse in the animal industry can contribute to drug resistance in people.
The FDA also explained that governments around the world consider antimicrobial resistant bacteria a major public health threat because “illnesses caused by drug-resistant strains of bacteria are more likely to be potentially fatal when the medicines used to treat them are rendered less effective.”
The Centers for Disease Control and Prevention, added that, “When the drug of choice for treating their infection doesn’t work, they require treatment with second-or-third-choice drugs that may be less effective, more toxic, and more expensive.
“This means that patients with an antimicrobial-resistant infection may suffer more and pay more for treatment.”
But the FDA does understand that there is still a legitimate need for antimicrobial drug use for livestock for therapeutic purposes to treat, control, and prevent disease in animal. Among the changes the agency wants to implement is veterinary oversight for the use of drugs and remove their over-the-counter status.
The FDA said that it is laying out plans for animal pharmaceutical companies to voluntarily revise the conditions of the use of their drugs from over-the-counter to prescription status, and only for therapeutic purposes.
The agency added that it would like to see veterinarians oversee the administering of the drugs. Prior to prescribing drugs, the FDA also said that it would like to see veterinarians use “judicious use” practices in determining whether it would be appropriate to use drugs in a particular situation.
The FDA said, for example, a veterinarian should consider the way the drug acts against a particular bacteria, whether it can effectively get to the place of the infection, and how long the drug maintains effectiveness at the site of the infection.
The agency says that other important factors that veterinarians will need to consider will be whether there is evidence that the drug will be effective in treating the particular disease; whether such preventative use is consistent with accepted veterinary practice; whether the use is intended to address a particular bacteria; whether the use is appropriately targeted to animals at risk of developing a specific disease; and whether there is no reasonable alternative for intervention.
The FDA said it is asking the drug sponsors – those who own the rights to market the products – to take a voluntary approach to changing the status of the drugs because “it is the fastest, most efficient way to make these changes.”
The FDA added that the alternative would be to “require that the agency proceed on a product-by-product basis which would likely create significantly more disruption to the animal health and agricultural industry, and would require significantly more resources and time to implement.”
The agency has been reaching out in this effort to associations representing drug companies, the feed industry, veterinarians, consumer groups, as well as producers of beef, pork, and turkey.
Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine, said “Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort.”
The FDA is asking animal pharmaceutical companies to notify the agency of their intent to sign onto the strategy within the next three months. These companies would then have a three-year transition period.
The agency added that once a product label is voluntary changed, it will be a violation of the Federal Food, Drug, and Cosmetics Act to use these products in feed for animal growth purposes.
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