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FDA Appeals Mandate to Ban Three Animal Antibiotics

After a magistrate judge ruled that the U.S. Food and Drug Administration must act on its long-standing proposal to ban the use of three antibiotics in animal feed because they may contribute to antibiotic resistance in bacteria, FDA is appealing the decision.

In a notice dated May 21, FDA Commissioner Margaret Hamburg, Director of the Center for Veterinary Medicine Bernadette Dunham and Secretary of Health and Human Services Kathleen Sebelius together filed an appeal with the Second Circuit Court of Appeals to overturn the March decision.

The ruling came after a coalition of 5 nonprofit organizations filed a suit demanding that FDA take action on an announcement it made 35 years earlier in 1977 that it would ban the use of penicillin and two types of tetracycline in animal feed in light of evidence that this practice was contributing to antibiotic-resistant strains of human pathogens.

If upheld, the decision will mandate FDA to follow through with drug company hearings that it must conduct in order to determine whether these drugs are indeed a threat to human health. If the antibiotics are found to be dangerous to humans, FDA must see that they are withdrawn from the market for use in animal feed.

© Food Safety News
  • Michael Bulger

    The principles of antimicrobial resistance resulting from the subtherapeutic use of antibiotics in livestock have been understood for over half a century. (http://www.nap.edu/catalog.php?record_id=21)
    Since then, the evidence of the public health threat that widespread, low-level use of antibiotics in animals represents has steadily grown. Modern genetic mapping has even allowed scientists to illuminate the development of resistant pathogens in hogs and show that these pathogens were then transferred to humans. (http://www.foodsafetynews.com/2012/02/drug-resistant-staph-linked-to-animal-antibiotics/)
    The fact that routinely giving livestock subtherapeutic levels of antibiotics is a public health threat has been acknowledge by the National Academy of Sciences’s Institute of Medicine and the World Health Organization. (http://www.keepantibioticsworking.com/new/KAWfiles/64_2_36444.pdf)
    FDA has favored a policy of politely asking the industry to curb the subtherpeutic use of human-class antibiotics. A range of professional and public organizations have called for an end to the practice of administering subtherapeutic antibiotics to livestock. These organizations include the American Medical Association, American Public Health Association, and American Academy of Pediatrics. (http://www.ucsusa.org/assets/documents/food_and_agriculture/pamta-endorsers-112th.pdf)

  • doc raymond

    The two tetracyclines named in 1977 are of minimal or no use in human medicine. Time to move on to the cephalosporin class of drugs and make an impact, not waste time on this issue

  • http://www.marlerblog.com bill marler

    From the Hill:
    A House Democrat accused the Food and Drug Administration (FDA) Friday of a “dereliction of duty” on antibiotic resistance after the agency appealed an order to ban three drugs in animal feed.
    “I suppose it’s not much of a surprise,” Rep. Louise Slaughter (N.Y.) said of the FDA. “They’ve buried their heads in the sand and ignored the threat of antibiotic resistance for well over 30 years. But avoiding this problem … only increases the threat to our public health.”
    Slaughter, a microbiologist, is outspoken in her support for ending the use of certain drugs in animal feed because the practice worsens antibiotic-resistant infections in humans.
    In March, a federal judge ordered the FDA to act on these concerns — a process regulators had started in 1977 but abandoned in December.
    “The FDA has not issued a single statement since the issuance of the 1977 [notices] that undermines the original findings that the drugs have not been shown to be safe,” wrote U.S. Magistrate Judge Theodore Katz, according to Reuters.
    FDA Commissioner Margaret Hamburg, Health and Human Services Secretary Kathleen Sebelius and Director of the Center for Veterinary Medicine Bernadette Dunham appealed this decision May 21, according to a notice.
    Antibiotic-resistant infections “kill more Americans than AIDS,” Slaughter responded in a statement Friday.
    “The FDA is tasked with protecting the health and well-being of the American people. So as far as I’m concerned, FDA’s decision to appeal … is nothing short of a dereliction of duty,” she said.
    Katz’s ruling would have forced the FDA to conduct hearings with drug companies on the safety of using certain drugs — penicillin and tetracyclines in particular — in livestock.
    If the antibiotics were found to be unsafe, the FDA would have to bar them from the animal feed market.
    The suit’s plaintiffs are five nonprofit organizations, according to Food Safety News.
    Slaughter is the author of H.R. 965, The Preservation of Antibiotics for Medical Treatment Act, which would prevent the overuse of seven classes of antibiotics.

  • doc raymond

    From the real world of human medicine:
    The tetracyclines are not players in your or my health issues. Just simply not players. Let’s get the FDA to focus on real issues like the cephalosporins, and not waste time and energy on these petty little drugs that used to be used to treat acne and not much else.

  • Harvey Cole DVM

    Just wrote a half page and lost it. past bed time so will be short
    Antibiotics for prevention should have never been allowed.
    The first experiment (I think by Cyanamid) was flawed and set up to make adding look good. No way to know if intentional or accidental.
    I had said much more bet do not know it if it will make any difference. Far past bedtime.