According to a Washington Post report filed this past weekend, the U.S. Food and Drug Administration (FDA) will likely approve the powerful antibiotic cefquinome for use in cattle. If the approval happens, it will be in the face of criticism from a variety of public-health groups, ranging from the American Medical Association to the FDA’s own Veterinary Medical Advisory Committee.
Critics of the measure argue that widespread use of the drug in cattle may very well hasten the development of “super-microbes†that are resistant to the potent antibiotic. (To date, none of the drugs belonging to cefquinome’s class of antibiotics have been approved for usage in animals.) Antibiotics like cefquinome are vital to human health because they are the strongest defense available against serious infections. By allowing the introduction of the antibiotic into the food chain, the FDA may be compromising the drug’s long-term effectiveness in humans.
At the core of the issue, says the Post, is a contentious new internal FDA guidance document known as “Guidance for Industry #152,†which has changed the parameters of cost-benefit analysis for animal-drug approvals. In short, the guidance document gives added weight to the concerns of industry and commerce while simultaneously lowering public-health standards in the approval process. The guidance document raises the burden of proof for rejection of new treatments in light of the new document, a direct threat to human health must be proved in order for a drug to be rejected for approval.
Drug maker InterVet Inc. had petitioned the FDA last year, hoping to get approval for marketing cefquinome for use in cattle. (The drug is used to fight bovine respiratory disease.) However, last fall, the FDA’s Veterinary Medical Advisory Committee recommended that the agency reject the proposal. The panel was concerned about increased resistance to the drug and noted that several effective alternatives already existed. Yet, Stephen Sundlof, chief of the FDA’s Center for Veterinary Medicine, made clear at the time that the guidelines set forth in document #152 would be the overriding criteria for approval or rejection.
According to public-health experts quoted in the Post, “the guidance makes it almost impossible to say no to a new animal drug unless it is likely to threaten the effectiveness of an antibiotic that is a critical player against food-borne illnesses. By contrast, the World Health Organization recommends saying no if approval would spur resistance to any antibiotic that is important for fighting ‘serious human disease’not just food-borne illnesses.â€
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