New U.S. FDA rules aim to cut antibiotic use in farm animals

Wed Dec 11, 2013 3:35pm EST

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(Reuters) - In a bid to stem a surge in human resistance to certain antibiotics, U.S. regulators announced new guidelines to phase out their use as a growth enhancer in livestock.

The Food and Drug Administration said the antibiotics could still be used to treat illnesses in animals raised for meat, but should otherwise be pared back over the next three years under a voluntary program to keep them out of the human food supply.

Although voluntary, the agency said it expects drugmakers to fully adhere to the new guidelines and on Wednesday announced that two of these biggest purveyors of those antibiotics had already agreed to narrow their use.

Doctors and hospitals have become increasingly worried in recent years by new strains of bacteria that cannot be controlled by a wide range of current antibiotics. Part of the suspected reason for the emergence of these "superbugs" is that people who have eaten meat that contained antibiotics develop resistance to the drugs as bacteria mutate to thwart them.

"Because antimicrobial drug use in both humans and animals can contribute to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary," the FDA said in a release.

In guidance issued on Wednesday, the FDA asked global drugmakers and animal health companies including Eli Lilly & Co and Zoetis to revise labels of medically important antibiotics by removing references to use in animal production.

Once companies remove farm production uses of their antibiotics from drug labels, it would become illegal for those drugs to be used for those purposes, Deputy FDA Commissioner Michael Taylor said in a conference call with journalists. The agency said about 25 animal health companies could be affected by the guidelines, especially Lilly and Zoetis.

Although the program is meant to be voluntary, Taylor said the FDA would be able to take regulatory action against companies that fail to comply.

The FDA's "final guidance," also brings the drugs under oversight of veterinarians by changing the over-the-counter status of the products.

The FDA said it will require animal pharmaceutical companies to notify the agency within three months of their intent to adopt its strategy. The companies would then have three years to complete the transition process.


Critics on Wednesday said the guidelines give drugmakers too much discretion in policing their own use of antibiotics.

Democratic lawmaker Louise Slaughter called the FDA move an inadequate response to the overuse of antibiotics "with no mechanism for enforcement and no metric for success."

Her view was echoed by consumer and environmental advocacy groups.

"Our fear ... is that there will be no reduction in antibiotic use as companies will either ignore the plan altogether or simply switch from using antibiotics for routine growth promotion to using the same antibiotics for routine disease prevention," said Steven Roach, senior analyst with advocacy group Keep Antibiotics Working.

Morningstar analyst David Krempa said the FDA issued similar voluntary guidelines in April 2012, meant to limit use of important antibiotics in food-producing animals, but they appear to have been largely ignored by farmers.

He said compliance with the FDA's latest set of voluntary guidelines could be equally spotty.

"Compliance will be tough because all the farmers and meat producers know these products increase the size of their animals," Krempa said. "They can continue to use them, and just say there's a disease going through their herds."

But even if antibiotics use in livestock indeed comes down, Krempa said it would be only a "small negative" for Zoetis because it, like other animal health companies, sells such a wide range of products for both livestock and pets.

The FDA said it had already received support for the new measures from Zoetis and Elanco, a unit of Eli Lilly, which sell a large percentage of the products that will eventually be phased out.

Elanco said in a statement that it would voluntarily narrow use of antibiotics used to treat both humans and animals "only to therapeutic purposes of treating, controlling and preventing diseases in animals under the supervision of a veterinarian."

Other companies with animal health businesses include Merck & Co, Novartis AG, Sanofi and Bayer AG.

Bayer and Sanofi said the FDA strategy would not affect the types of products they sell, but both companies said they support the FDA's position.

"It is important that these medically important antibiotics are used responsibly and with veterinary oversight," a Bayer spokeswoman said.

(Additional reporting by Esha Dey in Bangalore; Editing by Michele Gershberg, Matthew Lewis, Andrew Hay and Bob Burgdorfer)

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Comments (3)
ericmills wrote:
Long overdue. Reportedly, more than 80% of the pharmaceuticals produced in this country is fed to farm animals, often with dire consequences for those who eat these products over time. As I recall, it was a Prof. Tom Jukes at UC Berkeley who, back in the ’50′s, discovered that the “wonder drugs,” when fed to farm animals, made them gain weight quickly–no one was quite sure why. And now the chickens have come home to roost.

Relatedly, see the December 10 article in ROLLING STONE about the horrors of meat production in this country. We Americans consume some TEN BILLION animals every year (not including fish). Most never see the light of day, or set foot to earth–a true “crime against nature.”

Eric Mills, coordinator

Dec 11, 2013 2:17pm EST  --  Report as abuse
FRPSR wrote:
The so called freedom and liberty of the manufacturers who are at the root of this monumental problem (or evil) will explain this twice albeit in carefully group tested jargon .
Once is for how agents for change , or those leaders who as de facto if unelected , and unelectable , heads of the Republican party issue daily and quarterly ad hoc commands . Rushie Limbaugh , and Frankie I. Luntz , would force an obfuscation of any cooperative last ditch effort to save lives through policy if it performed any function threatening or impinging on the “right” to freely make money .
This would be the rich legacy of the now famous Republican say one thing do another that has produced the truculent know nothings who sneer at people and things they don’t pretend to understand . This has brought our news gatherers into the disgrace of broadcasting one howling barbarity after another . Or how gathering news now involves taking dictation from corporate public relations professionals , with no follow up questions please .
In order to acquire the sanctimony to carefully place lipstick on the arsenic allowances the “Clear Skies” initiative permitted , the endless gamesmanship of the right wings policy of delay , filibuster , and happy smiley double talk , has bequeathed this halfhearted action on the nightmare of twenty thousand dead people a year from antibiotic resistant viruses , bugs , and germs .
In pursuing this as a civil war , clearly dressing every issue as a confrontation the equal of surrender were compromise considered , the public has been served with an information campaign based largely on finger pointing , name calling , and propaganda . The reductions of complex , but never the less manageble issues , into crisis , or siege mentality , has promoted the efforts of fear mongering , and its serious name calling , finger pointing , agenda of monopolist corporations against any and all regulation , regardless of how obvious the need . This has given those who sell fear , alongside angry name calling , to those who argue for a consolidated effort of cooperation and research , the business of refuting the infinite strawmen raised up in transparently ludicrous conspiratorial hogwash . Rather than considering those policies which are unafraid of speaking truth to corporate power and producing a semblance of preservation alongside profits , we are drifting away from the opportunity to prevent global catastrophes .
The next explanation is how those who actually legislate carefully read the instructions from their de facto leaders back into English , and cry it is impossible to claim what everybody knows to be true , because we are no longer a representative republic we are a lobbyists republic .

Dec 11, 2013 3:30pm EST  --  Report as abuse
74LS08 wrote:
If we would reduced portions in the restaurants and at home it would have definitely helped with number of animals needed to be raised as well as help reduce obesity epidemic which actually turns ourselves into ugly looking animals.

Dec 11, 2013 4:31pm EST  --  Report as abuse
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