FDA’s Voluntary Guidance Failing To Curb Antibiotic Overuse In Farm Animals

Two years ago, the Food and Drug Administration — after decades of delay — paid lip service to the idea of reducing the use of medically important antibiotics for growth-promotion in farm animals, by asking the drug makers to voluntarily stop selling antibiotics specifically for that purpose. Critics called the FDA actions pointless while the drug and beef industries weren’t bothered in the least. And now, by the FDA’s own numbers, we can see why.

Today, the FDA released its annual report [PDF] on the sale of antimicrobials for use in farm animals, and the numbers are not a surprise to anyone who could see that merely asking drug companies to be more responsible was not going to cut it.

According to the FDA, between 2013 — when the voluntary guidance first went into effect — and 2014, sales of antibiotics for use in food-producing animals increased by 4%. Animals were also getting more drugs that are medically important for human health, with year-over-year sales of these antibiotics up 3%, in spite of the FDA’s weak-kneed efforts.

It’s these latter drugs — those that are vital to human health — that are often the biggest concern. Continuous exposure to low doses of such drugs can encourage the development of so-called “superbugs” that are resistant to the very antibiotics that are being used. These drug-resistant bacteria sicken some 2 million Americans — and kill thousands — every year, according to the Centers for Disease Control and Prevention.

Medically important drugs accounted for the large majority (62%) of drugs sold for use in food animals in 2014. Industry-backed critics of antibiotic regulation will likely point out that tetracycline — an older drug that is medically important, but no longer considered critical — represented 70% of these sales.

However, as researchers from Texas Tech and Texas A&M learned when they began using tetracycline in place of more urgently needed human antibiotics, drug-resistance only became more of a problem.

“We actually saw that resistance went up, which is not what we hypothesized,” Guy Loneragan from Texas Tech recently explained to Frontline. “Our viewpoint historically has been that, sure tetracyclines aren’t that important for human health so why worry about them in animal agriculture? But they may be more important than we think, not because of their use in human medicine, but because they can expand resistance to critically important drugs.”

Farmers and drug companies have long known that antibiotics can help promote growth in farm animals, resulting in a higher per-animal meat yield. The 2013 FDA guidance asked drug companies to, among other things, stop selling drugs that were solely used for growth-promotion. However, that had zero effect on sales because almost all drugs approved for growth-promotion use were already approved for therapeutic use. So anyone who had been buying an antibiotic primarily to get fatter pigs, cows, or chickens, just had to switch their reason from “growth-promotion” to “disease-prevention.”

Thus, per 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.

Additionally, 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.

“The data released today shows us that, despite industry assurances to the contrary, the use of human antibiotics on the farm have continued to rise,” says Susan Vaughn Grooters, an analyst with Keep Antibiotics Working.

She points to the increased use of cephalosporins (up 12% from 2013 through 2014), an important class of antibiotics on which the FDA placed restrictions in Jan. 2012. In spite of those rules, which ban the “extra label” use of cephalosporins, sales continued to increase.

“This troubling trend reaffirms that an approach, based largely on voluntary industry reductions, is inadequate faced with the public health crisis of antibiotic resistance,” says Vaughn Grooters. “There is no indication that FDA’s change in policy has yet resulted in any meaningful reductions on antibiotic sales and usage in food animal production. Over the counter sales clearly indicate that veterinary oversight couldn’t come soon enough.”

Earlier this year, California became the first state to prohibit the use of medically important antimicrobial drugs on livestock — except in situations where they are prescribed by a veterinarian. Additionally, the state outlawed the use of antibiotics solely for the purpose of weight gain. That means it’s not just going to be a regulatory no-no, but an actual crime, in California to use antibiotics strictly for growth-promotion.

Avinash Kar, of the Natural Resources Defense Council, says this is the kind of regulation that’s needed on a national basis.

“Dangerous overuse of antibiotics by the agricultural industry has been on the rise at an alarming rate in recent years—putting the effectiveness of our lifesaving drugs in jeopardy for people when they get sick,” says Kar. “We can no longer rely on the meat and pharmaceutical industries to self-police the responsible handling of these precious drugs. FDA must follow the lead of California and outlaw routine use of antibiotics on animals that are not sick in meat production nationwide. If we want to keep our antibiotics working for people when we need them, the agency must take urgent action.”

Earlier this week, the UK government released a report highlighting the many ways — from manufacturing, through animal and human waste — that overused antibiotics can make their way into the environment, putting everyone at risk for infections that can’t be fought off with the antibiotics we have now.

The report called for a global plan to reduce antibiotics in agriculture, especially as rising global economies — like Brazil, Russia, India, and China — increase their use of these drugs to meet growing demand from consumers.

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