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FDA Ordered to Reconsider Petitions on Antibiotics

A federal judge ruled this week that the U.S. Food and Drug Administration must reconsider previously denied petitions to ban certain medically important antibiotics used in animal agriculture.

The order comes just a few days after the FDA issued a notice that it will appeal a magistrate judge’s March ruling, which found that the agency unlawfully failed to act on its own 1977 proposal to ban penicillin and two types of tetracycline from animal feed despite evidence of a public health risk.

As part of its defense, the FDA has pointed to its new voluntary guidancepromoting the judicious use of antibiotics in food animal production — an approach the agency prefers because it requires less time and fewer resources than withdrawing individual animal drugs — but the court ruled that this approach does not excuse the agency from its duty to review the safety of the drugs and carefully consider the merits of the petitions.

“[T]he Agency has all but made a finding that the subtherapeutic use of antibiotics in food producing animals has not been shown to be safe,” reads the ruling by New York federal judge Theodore Katz. “In the course of this litigation, the Agency has conceded that ‘the phenomenon of antimicrobial resistance exists, [that] antimicrobial resistance poses a threat to public health, [and that] the overuse of antimicrobial drugs in food-producing animals can contribute to the development of antimicrobial resistance.’”

According to the most recent estimates, around 80 percent of all antibiotics sold in the United States – approximately 29 million pounds – are used to promote growth and control disease in food animal production each year.

The Natural Resources Defense Council — one of five advocacy groups that sued the agency after it failed to respond to petitions filed in 1999 and 2005 — called the ruling on Monday “another hugely important victory.”

The agency eventually denied both petitions last year, but the court ruled this week that the FDA did not provide proper legal justification for doing so. The court pointed out that the agency cited cost and time as key reasons not to move forward on the withdrawal proceedings, rather than focusing on safety and efficacy.

“This decision adds to the building momentum to end the unsafe use of antibiotics in livestock,” said NRDC staff attorney Avinash Kar.

The petitions filed by the coalition, which includes the American Academy of Pediatrics, the Union of Concerned Scientists, and the American Public Health Association, cover five classes of antibiotics, including penicillin and tetracyclines.

“Following the ruling, FDA must heed the science and make a decision about whether feeding antibiotics to healthy animals is safe for human health,” said Kar. “If FDA determines that such use is not safe, it must withdraw approval for the use of the antibiotics in animal feed.”

Robert Lawrence, director of the Johns Hopkins Center for a Livable Future, lauded the court’s decision.

“The rise of antibiotic resistance is a public health crisis. An important contributor to this grave public health threat is the continuing abuse of antibiotics in food animal production to make animals grow faster and prevent disease,” said Lawrence. “With this decision, a federal judge ruled that public health matters more than FDA’s excuses.”

….

Update: FDA said it is reviewing the decision, but the agency does not comment on pending litigation.

The Animal Health Institute, a veterinary pharmaceutical industry group, on Tuesday responded to the the court’s decision, saying it “adds confusion to FDA’s efforts to phase in veterinary oversight of antibiotics used in food animals while eliminating growth promotion uses.”

In April, FDA announced that it would ask veterinary drug companies to change the labels on antimicrobials so that farmers will be allowed to use the drugs only to prevent, control, or treat diseases and only under the supervision of a veterinarian  — and not for promoting growth or improving feed efficiency.

In the court’s decision this week, the judge acknowledged FDA’s guidance program encourages the industry to use the drugs judiciously, but criticized the strategy, arguing that the agency did not present “hard evidence that the drug sponsors have agreed or will agreed to the proposed measures.”

AHI said that the industry supports FDA’s initiative and is working to move certain medically-important drugs under veterinary supervision.

“Animal health companies will continue to support and work with FDA on the stakeholder process to achieve its goals of veterinary oversight and elimination of growth uses for medically important compounds,” said AHI. “This cooperative process will help avoid the unintended consequences of increased animal disease that have resulted from legislated bans in Europe.”

© Food Safety News
  • Walt deM.

    Quite the lineup of unbalanced agenda-driven extremist groups being quoted in this lively piece!
    Little wonder the FDA declined comment. FDA always declines “interviews” with known crackpot diarists lacking in journalistic integrity. A little balance, please!
    NRDC
    http://activistcash.com/organization_overview.cfm/o/19-natural-resources-defense-council
    UCS
    http://activistcash.com/organization_overview.cfm/o/145-union-of-concerned-scientists
    JHCLF
    http://www.consumerfreedom.com/2003/08/2076-johns-hopkins-meatless-utopia/
    APHA
    http://www.consumerfreedom.com/2011/04/756-going-way-beyond-public-health/

  • doc raymond

    It is getting old to keep saying this, but for proper balance I feel the need to try and make certain readers are not misled. It may be true that 80% of all antibiotics produced in the US are fed to animals, but over 30% of those antibiotices, esp the ones added to feed as growth promoters, are a class called Ionophores, and Ionophores are NOT used in human medicine. So no problem there. Of the remaining antibiotics used in animals, 40% are in the Tetracycline class of antibiotics. I seriously doubt one could find a physician that is concerned about antibiotic resistance in this class of drugs. The two tetracyclines listed in the 1977 report that this hubbub is all about have to be taken 4 times per day, cannot be prescribed for children, and have almost no current use in human medicine except for one sexually transmitted disease, a condition for which better drugs are available. Penicillin was discovered in the 1940s. By 1950 over 50% of Staph aureus acquired in hospital infections were resistant to penicillin, and it had not even been approved for animal use at that time. We need to look elsewhere to solve the problem of antibiotic resistant bacteria.

  • Jon

    Ha Walt! Using Consumer Freedom as a source (that bastion of Corporate coverup) — you’ve GOT to be kidding us!

  • Michael Bulger

    doc raymond,
    Antibiotics work by acting on bacterial cells. Different antibiotics do this in different ways. For instance, one antibiotic might break down the cell walls of a pathogenic bacteria. This would kill the pathogen. Another antibiotic might prevent the pathogen populations from growing. This could be done by interfering with protein synthesis. Antibiotics are often chemically similar, with common strengths and weaknesses.
    This is relevant to your comment because different antibiotics can act on bacterial cells in similar ways. They are also vulnerable to resistant pathogens in similar ways. Resistance traits can defend pathogens from antibiotics with similar chemical structures.
    Let’s say Pathogen X develops resistance to Tetracycline Y. The same traits that make Pathogen X resistant to Tetracycline Y, can also give Pathogen X resistance Tetracycline Z. This is referred to as “class resistance”.
    If I may further comment, penicillin-resistant Staph’s existence prior to penicillin’s widespread use in agriculture does not have much bearing on the discussion. If anything, it serves to further emphasize the need to restrain the subtherapeutic use of antibiotics. Prior to the acceptance of the principles of antibiotic resistance, penicillin was widely overused by humans. This led to the rise of resistant bacteria, just as the overuse of antibiotics today continues to create and encourage resistant bacteria.
    The use of antibiotics in human medicine promotes resistant pathogens. This does not lessen the fact that the use of antibiotics in livestock agriculture promotes resistant pathogens. A major difference is that humans need prescriptions. Another major difference is the subtherapeutic level at which antibiotics are fed to livestock. Subtherapeutic levels are particularly problematic when trying to avoid developing resistant pathogens.
    We need to look everywhere to solve the problem of antibiotic resistant bacteria. And livestock is a significant part of the problem with clear steps that can be taken to lower the risk of antibiotic resistance.
    Here is the CDC’s FAQ on the subject: http://www.cdc.gov/narms/faq_antiresis.htm

  • Ted

    Man, that brings back memories! Ah, Doc R., wouldn’t it be grand to turn back the clock to the time when you and I, too, were fearless wet-behind-the-ears pups who knew absolutely everything and would lecture piously on absolutely anything? Back when we also had all the easy answers.
    Yep, we also preached from our stone tablet of simple solutions for knotty problems that didn’t exist quite in the form we preferred (or that we insisted they should). What wonderful fun that was!!! Oh, to return to the day when crusading and forcing our boundless wisdom would be our sacred gift to an ignorant unappreciative uncouth world.
    Ah, yes, those were the days, my good friends, those were the days! Too bad reality has to intervene and complicate all of our simple answers and temper our youthful zeal. There is nothing quite as frustrating and fascinating at the same time as a stubborn science problem that refuses to be as simple-minded as the scientist would prefer. A good scientist learns his trade and systematically solves the riddle. A faux-scientist seizes the opportunity to turn the puzzling science problem into a social problem and sells it out as a political issue. So what if science doesn’t work that way, eh? We will vote on it and if that doesn’t work out right we will legislate the science into compliance with our wishes. Heh, yeah, that’s one approach, alright (that’s the new pop-science “Public Health”).
    I wonder, Doc, were we as arrogant, annoying and amusing as our pious young friend Michael the Boy Wonder when we were at his short pants stage of scientific study? Well, yes, we probably were full of beans and bullsh!t too. Maybe the Boy Wonder will grow into his tights…if he can ever stop tripping over his cape. If not, the craftily misnamed Union of Concerned Scientists can always use another cherrypicking faux-scientist to shill for them and scaremonger for their overblown donation-generating concerns.

  • Linus

    Suddenly, magically everyone is a physician or veterinarian or pharmacist because they share a popular opinion about antibiotics. M. Bulger’s pedantic rote pontification showcases the real problem here. There is far too much unsolicited noob advice from far too many amateur microbiologists and far too many quack healers reciting far too many oversimplified germ theories, all hell bent on screwing with proven food production systems and human health care systems they know absolutely nothing about. What could possibly go wrong with any of that?

  • Allison, NYC

    Ha Doc Raymond! I guess that precocious Michael Bulger sure showed you where the hypothetical bear X defecated in the illusory woods Y!
    Did you get all that with pathogen X and Y and Z and all? It probably went over your head Doc because it was so scientifically sophisticated and everything. There will be a quiz later. Better bone up on the cherrypicked reference. That’s what’s referred to as “class reprogramming”. We use it all the time at NYU. It works great!