Coalition For Animal Health
Questions FDA Drug Decision

WASHINGTON — The Coalition for Animal Health, consisting of every major livestock and poultry producer organization, the commercial feed industry, veterinarians and animal health companies, today expressed disappointment with government regulators for not doing their homework before pressing forward with a new animal drug approval framework.

"We are very concerned the Food and Drug Administration and the Centers for Disease Control and Prevention may wind up dictating their approach rather than working with producers and industry to develop a policy that actually addresses the resistance concern," said Joel Brandenberger of the National Turkey Federation, one of the Coalition’s member organizations.

"As it stands today," he said, "the framework pushed recently through the FDA’s Veterinary Medical Advisory Committee is ill-conceived because it includes no assessment of the actual risk posed to humans by antibiotic use in food animals, nor the potential for unintended negative affects on animal health."

Others expressed similar concern.

"Scientists, veterinarians and poultry and livestock producers testified at VMAC that the only way to develop a sound policy to address the concern of antibiotic resistance is to conduct a comprehensive risk assessment," said Lyle Vogel of the American Veterinary Medical Association, another Coalition member.

"By foregoing the risk assessment, FDA will have difficulty convincing stakeholders the framework is risk-based and will address the real resistance issue. The Coalition is left with serious questions about how to respond to this regulatory initiative."

FDA officials have said the framework is necessary because of increasing concern about the use in animals of certain antibiotics critical to treating human disease. Some scientists are worried that bacteria in farm animals might become resistant to the antibiotics and then transfer that resistance to humans through the consumption of undercooked meat and poultry.

Coalition members have no problem with a science-based examination of FDA’s antibiotic approval policy, but pointed out that highly respected scientific organizations have said there is not enough information currently available to change the FDA antibiotic approval policy.

"Three recent reports from the National Research Council, the Institute of Medicine and the World Health Organization do not come to the same conclusion FDA did in this proposed framework document," the Coalition said in a presentation to the VMAC on January 25.

The NRC report concluded: "information gaps hinder the decision-making policy process for regulatory approval and antibiotic use in food animals. A data-driven scientific consensus on the human health risk posed by antibiotic use in food animals is lacking."

Coalition members promised FDA leaders their full support in preparing a risk assessment and for any regulatory change indicated by such an assessment.

"We aren’t talking about an indefinite delay in changing the antibiotic approval process," Vogel said. "We’re talking about taking a few extra months to make sure the new approval process actually reduces the risk of antimicrobial resistance. Instead, FDA is preparing to implement a document that will reduce the availability of antimicrobials without necessarily reducing resistance."

Brandenberger said Coalition members are particularly upset with the assumption that antimicrobial use in animals is the major contributor to antibiotic resistance.

"Without an assessment, we’ve got a framework that may be totally out of proportion to the problem. It may turn out that we’re only contributing to 10 percent of the resistance problem yet having 75 percent of the solution imposed on us."