THE BLOG
02/19/2013 07:41 pm ET Updated Apr 21, 2013

Regulation Within the World of Antibiotics

This post is a response to David Wallinga's column, "Animal Antibiotic Use Continues Upwards, FDA Keeps Blinders On."

David Wallinga's Feb. 12 column only serves to perpetuate the fallacies surrounding animal antibiotic usage and completely mischaracterizes recent data released by the Food and Drug Administration and the agency's efforts to change the way antibiotics are regulated.

FDA last week released its third annual report of antibiotic sales for food animals. The data is collected by FDA from companies that produce and sell these products, then summarized in a public release that protects proprietary business information.

Notably, the data includes ionophores, an antimicrobial compound not used in human medicine. Since ionophores are not used to treat humans, it contributes nothing to the potential burden of antibiotic resistance and should not be included in the debate. In fact, European countries like Denmark also use ionophores in food animals and exclude them from statistics on antibiotic use. Even Margaret Mellon of the Union of Concerned Scientists said in 2007, "In the more than 10 years I've been in this issue, they've never been considered antibiotics."

Ionophores comprise 30 percent of the antibiotic sales in FDA's 2011 report. When ionophores are excluded, total use in food animals actually declined slightly.

Farmers and ranchers work closely with licensed veterinarians to ensure that antibiotics are used carefully and judiciously and administered only when they are needed in the lowest dosage possible. Several factors -- including weather, disease threats and number of animals -- impact the amount of antibiotics needed to protect their health. For more than 40 years, these medicines have played a critical role in keeping our national's food animals healthy and protecting animal health means protecting human health. Studies show that food safety begins with keeping animals healthy.

Frankly, it's a shame Wallinga dismisses FDA"s current efforts to phase out growth promotion uses and phase in veterinary oversight for antibiotics that are used in human medicine. This is a very real and ongoing effort that has the support of animal health companies. The next step in this process is the publication of two documents: A final guidance document instructing sponsors on what is required to change and eliminate certain label claims, and a proposed rule on the Veterinary Feed Directive, the mechanism used to extend veterinary oversight. It is anticipated that the publication of these documents will include start a three year clock for full implementation of this policy. Currently, the ball is in FDA's court and we urge quick publication of these documents and look forward to working with them to achieve this policy goal.

Once implemented, all antibiotic compounds important in human medicine will only be used for therapeutic, or targeted, purposes in the treatment of food animals under the direction of a veterinarian.

Dr. Wallinga actually works for the Institute on Agriculture and Trade Policy (IATP), which signed a letter to the White House in 2009 saying, "We support FDA's calls for phasing out the use of antimicrobial drugs for growth promotion and feed efficiency, and for requiring that all other uses of these drugs be carried out under the supervision of a veterinarians... " That is exactly the policy being implemented by FDA and we hope Dr. Wallinga will join us in urging FDA to publish the needed documents.

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