I wrote last week about a fundamental problem with the announcement: there is nothing binding about the guidance – they are simply FDA’s “recommendations” to industry. For change to happen, industry must choose to act on FDA’s recommendations. But that is only one of several problems plaguing FDA’s approach. Let me count some of the other ways:
1. Overuse of antibiotics on healthy animals will continue under the guise of “prevention,” (which FDA endorses), instead of “growth promotion.” As this insightful commentary from Dr. Robert Lawrence, a professor at the Johns Hopkins Bloomberg School of Public Health, points out:
Even if the food animal industry complies [with FDA's recommendations], however, the misuse of antibiotics will continue, because the guidance documents endorse the use of these drugs for disease prevention. Like growth promotion, this means feeding small quantities of antibiotics to food animals throughout their lives – a practice that has been shown time and again to select for antibiotic resistance. It is quite different from the preventive use of antibiotics in human medicine, which is relatively rare and involves the use of full doses for short durations.
Let’s be clear: when used for prevention purposes, antibiotics are not given to sick animals – they’re given to healthy ones. That’s why we object to nontherapeutic uses of antibiotics in livestock at a herd-wide or flock-wide level – both for growth promotion and preventively, to compensate for dirty, crowded conditions – that are not designed to treat a disease or administered to an individual animal or small groups of animals. FDA never explains why prevention uses are any safer than growth promotion uses. In fact, as Dr. Lawrence explains, they are not. FDA’s only explanation is that prevention uses are “necessary.” (More on that “necessity” below).
Given this potentially huge loophole, it would not be surprising at all to see industry embrace FDA’s guidance. In fact, we have already seen the first withdrawal of an antibiotic (Tiamulin) in animal feed for growth promotion uses. But as my colleague Steve Roach of Food Animal Concerns Trust has pointed out, the drug can still be fed continuously at low levels to entire herds of swine indefinitely for disease prevention purposes, even where no sign of disease has been found. Neither the regulation allowing prevention uses or FDA's recently announced guidance places limits on such use.
For other drugs that don’t already have approved disease prevention uses, the industry is blunt about its intentions to replace growth promotion uses with prevention uses. A recent story in the publication FDA Week reported:
Manufacturers will likely seek to make the voluntary label changes by applying for a new prevention indication for these low dose formulations, said Richard Carnevale, vice president of regulatory, scientific and international affairs at [the Animal Health Institute, a trade association representing pharmaceutical companies].
2. Prevention uses of antibiotics are only necessary because the livestock facilities are filthy and extremely crowded. Here’s another bit of key analysis from Dr. Lawrence in response to that claim of “necessity,” which provides cover for FDA allowing many of the existing practices to continue:
The guidance document defines disease prevention as follows: "the administration of antimicrobial drugs to animals, none of which are exhibiting clinical signs of disease, in a situation where disease is likely to occur if the drug is not administered" (emphasis added). The question of someone concerned about animal health should be, Why is disease likely to occur in the absence of an antibiotic? Asked the same question in the context of human health, an epidemiologist might consider such factors as sanitation, housing, and nutrition – three aspects of industrial food animal production that are sadly lacking.
Dr. Lawrence then appropriately points to the example of Denmark, which also has industrial livestock operations and is one of the world’s largest exporters of pork. Denmark has banned the use of antibiotics for both growth promotion and prevention uses and has reduced antibiotic use, and antibiotic resistant bacteria in meat, while increasing production and without economic harm. What’s the magic? Better management practices – including cleaner facilities and a little more space for the animals, combined with later weaning of animals and better nutrition.
Such changes in management practices are unlikely to cost very much to implement. A 1999 estimate by the Institute of Medicine of the National Academy of Sciences places the cost to the consumer of eliminating nontherapeutic uses of antibiotics (i.e. uses on healthy animals) at less than $ 1.25 per person per month in today’s dollars. That’s an unbelievably low price to pay for preserving the effectiveness of life-saving and essential medicines.
3. FDA’s justification for its voluntary approach – that it will take too long to address all the antibiotics individually – doesn’t hold up. First, FDA proposed to address multiple drugs in one hearing in 1977. There’s no reason it can’t do that now. Second, FDA has already carried out an extensive analysis of the science on antibiotic use in livestock and antibiotic resistance, as memorialized in the guidance it released two weeks ago. That science applies broadly across all antibiotics used in livestock, as FDA’s own guidance makes clear. FDA will not have to redo that work for each hearing it holds. Third, FDA has significant control over the manner and timing of administrative hearings and could move things along faster if it wanted. In fact, when FDA actually took regulatory action on one small class of antibiotics several years ago, the presiding administrative law judge had to rebuke FDA for proposing a schedule that was too drawn out. Finally, why wait? Antibiotic resistance is not going to take a break because FDA is kicking the can down the road. FDA should move forward with both approaches simultaneously if it sees virtue in the voluntary approach. Moving forward with the regulations may actually encourage drug companies to cooperate. The solution is not to reward resistance from the industry by wasting another three years (minimum). The solution is to regulate – and protect the public – faster.
The fact is that this is an agency that seems averse to action. FDA has known about these health risks for 35 years, and it’s just now getting around to issuing nonbinding guidance on antibiotics approved for use in animal feed. FDA has also long delayed action on other issues, like antimicrobials in soap and BPA. And now it is trying to delay any further action on antibiotics used on healthy animals by at least three years, while allowing industry to continue many of the existing uses even beyond that time frame should they voluntarily give up the growth promotion label and re-label their drugs for preventive uses. The clock doesn’t even start on FDA’s three-year timeline until FDA finalizes the draft guidance it released (Draft Guidance 213), which could take years. The final guidance (Guidance 209) released at the same time took almost two years to finalize. Plus, FDA is taking comments on the “proposed” 3-year schedule. Don’t be surprised to see industry saying they need longer.
We can’t afford to wait any longer. We need FDA to act now. FDA should heed its public health mission and stop protecting powerful industries that don’t need its protection and have been compomising human health for decades. FDA should move to protect public health by enacting binding regulations to end the unnecessary use of antibiotics on healthy animals.
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