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Groups Urge FDA Not to Appeal Court’s Decision on Antibiotics

Sustainable agriculture, animal welfare and consumer interest groups wrote to the U.S. Food and Drug Administration this week asking the agency not to appeal a recent court decision that orders the reconsideration of two petitions on subtherapeutic antibiotic use.

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, and there’s a growing concern that the practice is contributing to antibiotic resistance among foodborne pathogens and other bacteria.

The FDA has already appealed a March court decision ordering it to rescind feed additive approvals of penicillin and tetracyclines unless drug makers were able to demonstrate they are safe. Advocacy groups – including the The Johns Hopkins Center for a Livable Future, Food and Water Watch, and STOP Foodborne Illness – wrote to the FDA this week urging the agency to not appeal a June decision, which asks the agency to reconsider two petitions from 1999 and 2005 that were recently denied.

The court ruled that FDA did not provide proper legal justification for denying the petitions. 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.

“The new decision covers more medically important antibiotics in animal feed than just penicillins and tetracyclines, and more uses of them. Other antibiotics approved for animal feed include, for example, streptogramins, sulfas, aminoglycosides and macrocodes,” the groups explain in their letter to FDA Commissioner Margaret Hamburg.

The groups said that an agency decision not to appeal would not necessarily interfere with the FDA’s current voluntary approach, which encourages judicious use and seeks to bring medically important antibiotics under veterinary oversight.

“This is that rare opportunity when the FDA can do enormous good for public health by doing nothing – at least in terms of not appealing the decision by federal court,” said David Wallinga, of the Institute for Agriculture and Trade Policy, which organized the letter.

The Animal Health Institute, which represents veterinary pharmaceutical companies, argues that the recent court decision “adds confusion to FDA’s efforts to phase in veterinary oversight of antibiotics used in food animals while eliminating growth promotion uses.”

“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 last month. “This cooperative process will help avoid the unintended consequences of increased animal disease that have resulted from legislated bans in Europe.”

© Food Safety News
  • Ted

    None of these are “consumer interest” groups — they are more correctly characterized “agriculture hating” groups. Your crusading “animal welfare” groups in this instance are lobbying to deprive animals of effective medical care by leaving sick animals untreated to suffer, sink or swim. And your self-deluded ivory tower “sustainable agriculture” groups are looking to “level the playing field”. They think by destroying the abundant, safe, affordable food output of modern agriculture they will benefit when, out of food shortage and hunger consumers will be forced to pay exorbitant prices for “alternative” foods of dubious origin, quality and safety. What a lame coalition of self-absorbed lunatic fringe cults. FDA would have to be mad to consider unsolicited “advice” from any such nincompoops. These fanatics believe they are thinking with their hearts, reasonable people recognize if these extremists are thinking at all it is with something else…and definitely not with their brains. Far, far from “consumer interest” groups seeking progress for civilization, these are decidedly self-interest groups seeking political power for themselves.

  • There seems little doubt that the continual injection of a given class of antibiotics into a local environment is concomitant with a rise in the frequency of resistant microorganisms (some of them pathogenic) in that same environment. This matter is controversial for two reasons: (a), Some folk see the correlation as implying causality in need of regulation (i.e., antibiotics of a given class injected into an environment necessarily leads to the emergence of antibiotic resistance to that same antibiotic class within that environment) while opponents proclaim that correlation by itself does cannot imply causality (which is true as far as it goes) and (b), It seems that the industry makes use of many of the same antibiotics that humans rely upon. This is entirely unnecessary.
    Years ago, I have watched a three or four year old infant with meningitis caused by a multiply-antibiotic-resistant pathogen in the process of losing his battle for life because the hospital had nothing to treat him with that worked. Fortunately, I was, at the time, conducting research on a novel antibiotic, which had not yet made it to market. Consequently, resistance to this drug had not yet had time to develop. I obtained a sample of the organism doing this kid in and was able to show that the new antibiotic was able to inhibit its growth. Because this child was so near death, his attending physician was able to make use of this information to obtain special permission to administer an unlicensed drug to this boy. He was cured of the infection within a day of starting a course of that new antibiotic. The difference today is that we have very few new antibiotics in the pipeline and that pharmaceutical research is making what I consider to be a very ill-advised move to China.
    Why let this controversy fester to the point that those opposed to the veterinary use of antibiotics used also to treat humans felt their only alternative was to establish legal responsibility through one or more class action lawsuits? Many of the antibiotics originally for human use have never made it to market because studies showed that their use in humans involved an unacceptable amount of risk for humans. What is toxic to a human may not be so for a bovine, pig or chicken. It just seems to me that this entire controversy would “go-away” if the meat industry were to undertake an intelligent survey of the pharmaceutical industry’s “failures” and repurpose these for the mutual benefit of both sides.