Predictable Problems in the FDA Annual Report

Not only did the FDA’s voluntary Guidance for Industry #213 not lower the sale and use of antibiotics for food-producing animals, these sales actually increased 4%.

Food & farming

Bill Wenzel

In 2013,the Food and Drug Administration (FDA) put forward a weak plan to address the overuse of antibiotics in agriculture. After decades of warnings from scientists and health experts, the FDA passed voluntary guidelines meant to lower the use of antibiotics on livestock and poultry. We were confident these would prove insufficient, and urged the agency for stronger action. This week’s annual report on the sale of antimicrobials for use in farm animals validated our concerns.

Not only did the FDA’s voluntary Guidance for Industry #213 not lower the sale and use of antibiotics for food-producing animals, these sales actually increased 4%. Animals also received more drugs important for human medicine, with sales of these antibiotics up 3% yearly, totaling 62% of all sales.

It’s these – the antibiotics considered “medically important” – that are most concerning. We’ve known that misusing antibiotics caused them to lose effectiveness since Alexander Fleming accepted the Nobel Prize for his discovery of penicillin in 1945. As his warning has gone unheeded, we’ve seen a rapid rise in antibiotic resistance and infections that are difficult, if not impossible, to treat.

Despite the risks, livestock and poultry producers, especially those operating large, confined production systems – commonly known as factory farms, continue to insist that their use of antibiotics is safe. So, while disturbing, the findings of the FDA’s annual report is not particularly surprising, as the facts predicted such an outcome from the start. 

Under the Guidance, FDA recommended that pharmaceutical companies voluntarily remove labels from antibiotics that indicated the drugs could be used to promote growth. Years earlier, similar industry guidelines had already proved ineffective in Denmark. There was no reason to assume it would be different here. Farmers already purchased the vast majority of antibiotics for the reported purpose of preventing disease – that animals grew fatter on less feed was merely a convenient side effect.

Factory farms have used antibiotics to promote growth in farm animals for decades. The 2013 FDA guidance presumed that asking drug companies to stop selling drugs solely for this purpose would be enough to lessen overall antibiotics use on farms. Because almost all drugs approved for growth-promotion use were already approved for therapeutic use, antibiotics sales were hardly touched. Farms simply had to switch their reason for buying and using the drugs from “growth-promotion” to “disease-prevention.”

According to initial reports by Consumerist, citing the FDA report, “the percentage of therapeutic drugs sold that have known growth-promotion benefits remained flat at 72% in the year after the agency’s guidance was released… [and] while the FDA has tried to impress upon the need for veterinary oversight on these antibiotics, 97% of all medically important drugs were available in 2014 without a prescription or a veterinary feed directive.” As long as livestock and poultry producers can purchase antibiotics over the counter legitimately for the purpose of disease prevention, we’re walking swiftly down the path towards a post-antibiotic era, in which our life-saving medicines no longer work.

The World Health Organization warns that without swift, coordinated action, this will be the reality we all face in less than 50 years – and by recent indications, sooner. Just last month, a bacterial gene resistant to even our last-line of antibiotics was found in both China and, later, Denmark. CRE bacteria, dubbed “the phantom menace,” is on the rise across America, and studies continue to connect the rise of another superbug, MRSA, to antibiotics overuse on farms. These troubling trends, combined with the FDA’s report, reaffirm that voluntary industry reductions will be neither swift nor coordinated enough to address the public health crisis of antibiotic resistance.

There is good news. In the face of government inaction, the marketplace is pushing the industry to change. This year, we helped push McDonald’s – the largest in market share – and Subway – the largest in size, to make commitments to stop buying meat raised on antibiotics. As a result, their suppliers had no choice but to end their antibiotics overuse. Similar commitments by a growing number of restaurant chains, and the support of hundreds of thousands of consumers, are helping push the industry in the right direction.

We aren’t done. In 2016, we’ll work to move more of the market towards raising meat without the routine use of antibiotics. With enough consumers, health care professionals, public health and environmental organizations, we can convince more chains to put public health first. 

That doesn’t let the FDA off the hook. Now that their voluntary Guidance for Industry #213 has bared its false teeth, it’s time for the agency to set a stronger, more meaningful plan to combat antibiotic resistance at one of its primary origins. We now have definitive evidence that as long as producers are permitted to use antibiotics for disease prevention in animals that are not sick, antibiotics misuse on farms will continue. More must be done. Nothing less than a ban on the routine and unnecessary use of antibiotics on livestock and poultry will halt this trend, and ensure that our life-saving medicines can remain effective for generations to come. 



Bill Wenzel