FDA Finally Imposes Some Controls on Agricultural Antibiotics. Sort Of.

USDA Photos by Lance Cheung/Flickr

This morning, the US Food and Drug Administration dropped some long-awaited-but-still-big news regarding the use of antibiotics in meat production. Tl;dr: The FDA asked (but did not compel) the livestock industry to stop using the micro-dose “growth promoter” antibiotics that are widely believed to contribute to increase in antibiotic resistant bacteria in animals, food and humans.

With exquisite timing, they happen to have picked a day when I am traveling, in order to get to my end-of-semester evaluation tomorrow for my  MIT fellowship. So I’m going to do what curation I can on this, and point to some important reactions and analyses. I’ll come back for a deeper look, probably on the weekend.

So here are the basics.

What did the FDA do?

The action: The agency released two documents, the Final Guidance for Industry 213 and the Draft Veterinary Feed Directive.

The significance: In April 2012, the FDA announced that it intended to ask the livestock industry to control the main way it uses antibiotics in meat production, by phasing out the use of micro-dose “growth promoters” that cause animals to put on weight faster than they would without the drugs. These two documents provide the road map for the industry to do that. Guidance 213 addresses the details of implementing the policy. The Feed Directive addresses one set of those details: Growth promoters are given to livestock in food and water.

For more: Here’s the FDA’s press release and a companion FAQ.

Why is this significant?

About 80 percent of the antibiotics sold in the US each year, by weight, are used in agriculture, not in humans, and the majority of that 80 percent is used for “growth promotion and disease prevention and control,” not for treatment of sick animals. (The industry disputes that math; in October, the fact-checking site PolitiFact drilled down into sources and judged the number to be correct with some narrow caveats.)  Growth-promoter antibiotics are widely believed by scientists (and documented in a vast scientific literature; one summary here) to foster the development of  antibiotic-resistant bacteria in animals and in a farm’s environment. Those bacteria move off the farm — in the animals, their manure, the meat they become, and via water, wind, and insects — to cause human illnesses that are difficult to treat or untreatable. This process is taken for granted in Europe, which banned growth promoters in 2006.

Why did you call this “long-awaited”?

The FDA first proposed putting controls on growth promoters in 1977, saying that it planned to revoke the licenses it granted in the 1950s for penicillin and tetracycline to be used in that way. Thanks largely to Congressional interference (see this post for the details and a timeline), it never succeeded.

And the details are?

Veterinary pharma companies should remove from the labels of their antibiotics any language (the technical term is “indication”) saying that the drugs can be used as growth promoters, to fatten animals, or for “feed efficiency,” which means using less feed to get to an expected weight. They should not allow the drugs to be sold over-the-counter (which in this case means via farm-supply channels — not, you know, on a rack at the drug store). They should instead list them as “Veterinary Feed Directive” drugs, which required that they be prescribed by a veterinarian; this should end the OTC use of farm antibiotics in feed and water. (More on that a little lower down.)

Does this prevent farmers from using antibiotics to treat sick animals?

Absolutely not. (And it would be a violation of animal welfare to try.) What these Guidances and the VFD do is to restrict antibiotics when they are not used for illness, and to (attempt to) dial back the much more abundant uses that have nothing to do with animal health.

Is this mandatory?

No — and that is the biggest criticism of the plan and its largest potential loophole. This plan is not legislation, nor a regulation; it is entirely voluntary. (Hence the “shoulds” above rather than “musts.”) If you look at the Guidance document itself, it is prominently labeled “Contains Nonbinding Recommendations,” and also says: “This guidance … does not create or confer any rights for or on any person and does not operate to bind FDA or the public.”

Companies have 90 days to signal to the FDA whether they agree to follow this plan. Could they defy the agency and continue to sell their products for growth promotion? Probably they could; but the FDA has promised to make transparent which companies sign up and don’t, apparently counting on public pressure to get companies to move. Already, one major vet-pharma company,  Zoetis, has put up a statement in favor. (I’ve heard Elanco has as well, but haven’t seen a statement.) And in maybe the clearest sign of how seriously the industry takes this development, the Animal Health Institute — whose members make veterinary antibiotics — announced yesterday that it would hold a press conference on the FDA’s announcement, roughly 20 hours before the FDA acknowledged that the announcement was going to happen. (I got the AHI email at 1:32pm yesterday and the FDA media advisory at 9:11 am today.) Here’s the AHI’s statement.

So is this all settled now, or are there problems ahead?

Definitely not settled. First, because this is a three-year phase-in, with re-evaluation at the end. Second, because the VFD (which governs how antibiotics will now be administered) is not final; it is in draft and open for public comment. Third, because there is past history to indicate that these bans — voluntary or regulated — don’t always go as planned: When the Netherlands attempted to restrict growth promoters a decade ago, their overall annual antibiotic sales did not change. Instead, the drug just got sold in different categories.

Will there be any attempts to control definitional switcheroos like that?

Deep in Guidance 213, there is language that addresses the mushy middle category of livestock antibiotic use: not growth promotion/feed efficiency and not disease treatment, but “disease prevention and control.” In plain language, “prevention and control” protects animals from the crowded conditions in which they are raised, and provides the industry with a cheap alternative to doing the expensive work of changing those conditions (which would mean, for instance, later weaning and lower stocking density). The FDA has never before addressed that middle category, yet in 213 it lays out several bars that must be cleared for a drug to legitimately be considered preventive, and not just a Band-aid. It’s a possibly encouraging sign.

Who has something to say about this?

I’ve gotten statements so far from:

Finally, Rep. Louise Slaughter (D-NY), who has pressed for years to restrict ag antibiotics that are identical to human-use drugs in the proposed legislation PAMTA, called the FDA steps “inadequate” and lacking in enforcement power, and said she would press for a meeting with the FDA today. No word yet on whether that happened.

That’s what I’ve got so far; more to come I am sure. Meanwhile, these posts will fill in background.





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