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Disclosed: FDA's confidential strategy memos on (not) regulating antibiotics in livestock

Jonathan Kaplan

Posted October 23, 2012 in Curbing Pollution, Living Sustainably

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In private, agency sounds less confident about its voluntary approach in lieu of binding regulatory action

It’s hard to explain the significance of newly disclosed FDA memos without first providing a refresher on the problem of antibiotics use in livestock:

Recall that eighty percent of all antibiotics sold in the U.S. are used for food animals, a practice that breeds resistant “superbugs” that now threaten people.  FDA has ignored this problem for 40 years.  Really.  If you’re following NRDC on this, you’ll also remember that we sued FDA last year, demanding regulatory action to curb this threat.  FDA responded by publishing a voluntary non-binding “guidance” that merely makes recommendations about reducing antibiotic use.  The agency insisted in public, and to the court, that the voluntary approach was a better way to get the job done.  Fortunately, the judge didn’t buy it and ordered FDA to start withdrawing approval for drug uses if drug manufacturers couldn’t prove their safety (although FDA has since appealed).

Which brings us to the present:  FDA “strategy” memos, marked confidential, were  released last week by our friends at the Public Employees for Environmental Responsibility (PEER).    These documents are full of statements conceding that the agency’s 100% voluntary approach might not work:

 

...  “We recognize that the voluntary strategy has certain limitations in that (1) it lacks specifically defined/mandated timeframes; (2) its success is dependent on drug sponsors deciding it is in their best interest to work cooperatively with the agency; and (3) FDA collects insufficient data on drug use…to measure the effectiveness of the strategy.”   To address these limitations, several additional options are presented below for consideration.” ...

…  “If the voluntary approach does not achieve our goals, there are several regulatory options available to us.” ...

...  “Recognizing, however, that the voluntary approach will only work if all sponsors decide it is in their best interest to work cooperatively with the agency to achieve these goals, CVM [FDA’s Center for Veterinary Medicine] also suggests that setting out some timeframes within which we expect to see progress toward achieving these goals.”...

PEER staff received these documents as part of a Freedom of Information Act request for FDA’s evidence that a voluntary approach might work to curb antibiotic misuse in the livestock sector.  The documents they received show that agency managers are far from sold that the voluntary approach will succeed.  More importantly, PEER tells us that nowhere in the 12 inch pile of documents that they received from FDA was any shred of evidence suggesting that pharmaceutical companies or livestock conglomerates are ready to walk away from business as usual.

 

For more about the over-whelming scientific evidence linking livestock use of antibiotics with human health risks, and NRDC’s litigation and advocacy to address the problem, read my colleague Avinash Kar’s blogs here.

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Comments

Eldridge GallowayOct 25 2012 10:41 AM

Recall that eighty percent of all antibiotics sold in the U.S. are used for food animals

, a practice that breeds resistant “superbugs” that now threaten people. FDA has ignored this problem for 40 years. Really. If you’re following NRDC on this, you’ll also remember that we sued FDA last year, demanding regulatory action to curb this threat. FDA responded by publishing a voluntary non-binding “guidance” that merely makes recommendations about reducing antibiotic use. The agency insisted in public, and to the court, that the voluntary approach was a better way to get the job done. Fortunately, the judge didn’t buy it and ordered FDA to start withdrawing approval for drug uses if drug manufacturers couldn’t prove their safety (although FDA has since appealed).

Which brings us to the present: FDA “strategy” memos, marked confidential, were released last week by our friends at the Public Employees for Environmental Responsibility (PEER). These documents are full of statements conceding that the agency’s 100% voluntary approach might not work:

David BurchOct 26 2012 04:40 AM

Recent work has shown that 16.34% of US citizens receive antibiotics each year, or in populations terms 16,340/ 100,000 population. It was calculated that the transmission of infections from pigs to man is 0.0031% of cases or 3.1 cases/100,000. If all these infections carry resistance genes, then that is the transmission rate of resistance to man. So where is all this threat coming from? Widespread use of antibiotics in man or occasional infections from pigs?

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