FDA Guidance 213: Is it a good thing? (commentary)

FDA Guidance 213: Is it a good thing? (commentary)

ON Dec. 12, 2013, the Food & Drug Administration announced that the long-awaited "Guidance 213" had been finalized, signaling a 90-day response period for pharmaceutical companies that produce and sell antibiotics to be used in animals.

In a very simplified nutshell, 213 calls for voluntary suspension of using "medically important" antibiotics for growth promotion in animals and moving all antibiotics under veterinary oversight.

For reference, many estimates claim that around 15% of all antibiotics sold for use in animals fall under the growth promotion indication.

Many bits and pieces of 213 are debatable and questionable, and I think "medically important" is one of those. By definition, FDA uses the phrase to mean any antibiotics ever used, no matter how rare, in human medicine. That is a story for another day, though.

The response FDA asked for within 90 days was how each pharmaceutical company intended to change its labeling regarding 213. The companies have three years to enact the changes they announced within the 90-day time frame for action.

Their choices are basically to drop the label of growth promotion and the product for the purpose of growth promotion or to change the label, with FDA approval, to something else, like control or prevention.

The new indication label would be approved only if scientific data supplied with the request convinced FDA that the change was appropriate.

Many food safety advocates and related advocacy organizations spent a lot of time and energy bemoaning the fact that FDA made this a voluntary — as opposed to a mandated — change. A March 27 announcement by FDA indicated that the naysayers need not have worried.

According to FDA, the number of companies confirming — in writing, within the 90-day response period — their intent to engage in further discussions regarding 213 was 25.

Significant? Yes.

You see, only 26 companies are affected by 213, and the 25 responding companies sell 99.95% of the antibiotics used for growth promotion.

I take that as an overwhelming sign of compliance to a voluntary call for action and a sincere effort by the pharmaceutical industry to avoid, at all costs, any unintended consequences of using antibiotics in animal husbandry.

Another FDA intent is to make all medically important antibiotics given to animals fall under the direct supervision and written prescription of doctors of veterinary medicine (DVMs).

Again, to oversimplify a sweeping change, the yet-to-be-finalized veterinary feed directive will ensure veterinary oversight of medically important antibiotics used in feed. Contrary to claims by some in the animal agriculture industry, this simply is not how it works today.

Some breathe a sigh of relief and imply that this will end the overuse or unnecessary use of antibiotics just because they will be under a DVM's supervision.

I like and respect my friends who practice veterinary medicine, but I know there are still some financial incentives out there to prescribe antibiotics.

I also know that all antibiotics used in human medicine are directly or indirectly under the supervision of my friends in the human health arena, yet we all know way too many antibiotics are prescribed inappropriately in this area, contributing to antibiotic resistance in pathogens that can make us sick.

Supervision by a professional should not signal an end to the need for due diligence.

So, regarding the question I posed in my title — "Is this a good thing?" — in my humble opinion, I don't think so.

More than 10 years ago, Denmark initiated a ban on the use of antibiotics for growth promotion in food animals if those antibiotics also are used in human medicine. The Danes saw the overall amount of antibiotics prescribed by DVMs climb more than 100% over 10 years as the number of animals being treated with stronger, longer-duration antibiotics for infections rose dramatically.

Which is more likely to create antibiotic resistance: a lower dose to prevent infection or a higher dose to treat an infection? I don't think anyone has answered that question yet.

What Denmark has not seen is a reduction in antibiotic-resistant pathogens in human medicine. I don't think we will either.

The antibiotics being banned are not, for the most part, of critical importance in human medicine. Two of the top four classes of human antibiotics — cephalosporins (Keflex, for example) and flouroquinolones (like Cipro) — comprise only 0.3% of all antibiotics used in animal agriculture because of prior FDA actions taken to keep them working for people.

They are not used as a feed additive, they are not used to promote growth and they are administered only with DVM supervision for very carefully defined illnesses.

Perhaps banning the use of antibiotics for growth promotion will also produce more sick, infected animals. That, then, becomes a humane and animal wellness issue.

Denmark saw it, but its action was almost overnight by statutory mandate. Will three years be enough for the U.S. industry to prepare and change to keep this from happening here? Only time will tell.

The next steps are up to the pharmaceutical companies. For the sake of openness and transparency, I do consult for some of the companies affected by FDA "Guidance 213," I am currently working with the National Institute for Animal Agriculture to help it plan a fourth symposium on the use of antibiotics in animals, and I serve on the Tyson Foods Animal Well-Being Advisory Panel.

When I blog, none of the companies with which I am engaged advise me on what topic to choose, nor do they proofread before submission. These thoughts are mine, and mine alone.

For a trained medical doctor, animal agriculture has been very good to me. I hope I can return the favor in some small way.

*Dr. Richard Raymond is a former U.S. Department of Agriculture undersecretary for food safety.

Volume:86 Issue:14

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