Outside editorial: FDA issues timid rules for antibiotics in the food chain

The following editorial appeared in the St. Louis Post-Dispatch:


The U.S. Food and Drug Administration once again took timid steps last week to address the danger posed to human health by the use of antibiotic drugs in food-animal production.

The FDA has taken this go-slow approach to the problem for nearly four decades. In the meantime, the agency—caught between science and duty on one side and the crushing political muscle of Big Farm and Big Pharma on the other—has allowed the danger to grow.

The problem arises from two related phenomena:

First, large-farm production of animals for human consumption now includes the administration of low doses of antibiotics through feed and water. The dosages are too small to treat or prevent infections, but they increase the efficiency of the feed and make the animals bigger.

And over time, enough gets distributed throughout animal herds to foster the evolution of bacteria strains that are resistant to treatment with the antibiotics. That puts people at increased risk of more serious disease and death when they become infected with the drug-resistant strains of E. coli, salmonella and other dangerous diseases.

Last week, the FDA, the federal agency responsible for drug safety and effectiveness, announced a multi-part voluntary program to address part of the animal-antibiotic problem.

The agency released guidance for farmers, ranchers and agricultural production companies recommending — but not requiring — that they gradually stop using antibiotics identified as important in the treatment human diseases.

The FDA also asked drug manufacturers to voluntarily change their package labels to say that the antibiotics should not be used to improve production but still may be used, when recommended by a veterinarian, to prevent or treat animal disease.

Finally, the agency published the draft text of a proposed regulation (which it may or may not issue) aimed at helping veterinarians accommodate their increased (voluntary) oversight responsibilities for the use of the antibiotics.

Obviously, “voluntary” only goes so far. In addition, critics of agricultural antibiotic use point out that the FDA created a huge loophole through which producers could continue current dangerous practices by claiming that the drugs were needed for “preventive” purposes.

The political pressure on the FDA is no illusion. The final order it issued in January, for example, banning most agricultural animal uses of just one class of antibiotics — cephalosporins — began with a rule that first was published in 2008, then withdrawn in a storm of industry complaints, modified and reissued in softer form.

Last month, a clearly irritated federal magistrate in New York ordered the FDA to finally complete an animal antibiotic rule-making process it began, astonishingly, in 1975. Since then, under considerable political pressure from Congress, the agency has since done its best to avoid its own findings regarding overuse of penicillin and two kinds of tetracycline.

Medical infectious disease specialists note that misuse of antibiotics in animal agriculture clearly produces dangerous drug-resistant bacteria. But over-prescription and overuse of antibiotics by people, they say, is a more significant factor. They also emphasize that preventing infections when possible through widespread vaccination programs is invariably a wiser course than trying to treat them after the fact.

Nevertheless, there is no scientific doubt that the misuse of antibiotics in food-animal production puts human health at increased risk. The FDA’s first priority must be protecting human health. It needs to find the courage to start taking more definitive action.


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