When it comes to Big Pharma, Big Food, and Public Health, guess who bats last at the federal Food and Drug Administration. Time to yell and pound on your loudest cooking utensils! -- blj
New York Times
The F.D.A.’s Not-Really-Such-Good-News
By MARK BITTMAN
That “good” news you may have read last week about the Food and Drug Administration’s curbing antibiotics in animal feed may not be so good after all. In fact, it appears that the F.D.A. has once again refused to do all it could to protect public health.
For those who missed it, the agency requested (and “requested” is the right word) that the pharmaceutical industry make a labeling change that, the F.D.A. says, will reduce the routine use of antibiotics in animal production. I’d happily be proven wrong, but I don’t think it will. Rather, I think we’re looking at an industry-friendly response to the public health emergency of diseases caused by antibiotic-resistant bacteria, resistance that is bred in industrially raised animals.
You may know that around 80 percent of antibiotics in the United States are given (fed, mostly) to animals. Why? Because the terrible conditions in which most of our animals are grown foster illness; give them antibiotics and illness is less likely. There is also a belief that “subtherapeutic” doses of antibiotics help animals grow faster. So most “farmers” who raise animals by the tens or hundreds of thousands find it easier to feed them antibiotics than to raise them in ways that allow antibiotics to be reserved for actual illness. (And yes, there are alternatives, even in industrial settings. Denmark raises as many hogs as Iowa and does it with far fewer antibiotics.)
You may also know that this overuse of antibiotics is leading to increasing bacterial resistance, that we’re breeding an army of supergerms. This isn’t theoretical: The Centers for Disease Control and Prevention estimates that 23,000 Americans died of illnesses related to antibiotic-resistant bacteria each year. Another two million were sickened. (Some experts say that these numbers are low.) This makes resistant bacteria a greater health threat than AIDS, and there is talk by the C.D.C. of a post-antibiotic era.
The only solution, say most experts, is to stop the prophylactic use of antibiotics and use the drugs only to treat animals that are actually sick. (This is not news: Alexander Fleming, the discoverer of penicillin, feared microbial resistance and discussed it in hisNobel Prize speech of 1945.) Preventing this is an ostensible goal of the F.D.A., which itself predicted — in 1977 — the very scenario in which overuse of antibiotics would lead to superbugs and, at that time, proposed to limit their use. But Congress got in the way and in the intervening years the agency appears to have been infiltrated by industry-friendly administrators who publicly write that “Using these drugs judiciously means that unnecessary or inappropriate use should be avoided,” yet manage to avoid enforcing these pronouncements.
The story of the last 36 years is one of inaction. The F.D.A. is already under a federal court order to “ensure the safety and effectiveness of all drugs sold in interstate commerce,” and to withdraw drugs demonstrated to be unsafe — a court order the agency has appealed twice. One could see the new guidelines as little more than an attempt to convince the court to set aside its ruling.
Technically, reducing antibiotic use is simple. The science tells us it is the thing to do, the meat industry has the capability of designing animal-growing facilities that would foster less disease and, perhaps most important, the F.D.A. has the power to rule — not suggest — a complete ban of the use of antibiotics for growth promotion and disease prevention in livestock.
This last statement is contentious. (If you want to make your own judgment about the F.D.A.'s legal power, have at it.) Michael Taylor, the agency’s deputy commissioner for foods and veterinary medicine (and — just in case you think the notion that there is a revolving door between the F.D.A. and the food industry is hyperbole — a former vice president for public policy at Monsanto), told me, “The approval of a new animal drug for specific indication is like the granting of a license; it applies to that company. There’s a prescribed process for withdrawing that license … a very formal administrative process. We can’t just issue a rule of general applicability that extinguishes their due process rights.
“We don’t feel we have the legal authority,” he continued, to do “what might be great to do from a public health policy standpoint. You’d have to show product by product that each is contributing” to a resistance problem. “This is a strategy to drive this to closure in the quickest way possible. We expect and hope folks will watch us closely.”
We are talking about 287 different drugs, and Taylor says it might take “three or four years” to go through the process for each one. These guidelines, he says — which were developed with the cooperation of the industry (uh-huh) — will work faster.
But there are other ways of looking at the F.D.A.'s ability to regulate. These drugs fall into seven categories; nothing was preventing the agency, three or four years ago, from picking a drug from each category and beginning what Taylor calls “a very formal” process. Nothing prevents them from doing it now — simultaneously with their new guidelines — except, I would suggest, a desire to maintain a noncontentious relationship with Big Pharma and Big Food. As each drug, or category, was demonstrated to be unsafe, the process would become less cumbersome and something “great” might actually be done for public health.
It’s not just me saying this.
Margaret Mellon, a lawyer and a senior scientist at the Union of Concerned Scientists, said to me, “The agency can legally withdraw the label claims approvals if it can show that uses under the label circumstances are no longer safe in terms of resistance.”
When I asked Representative Louise Slaughter — who happens to be a microbiologist, and is among the few in Congress with both the knowledge and spine to call out the F.D.A. — whether the agency had the authority to ban antibiotics for any use except direct treatment, she barely let me finish my question before exclaiming, “Of course they do.”
And Robert Martin, a program director at the Center for a Livable Future at Johns Hopkins and a former director of the widely respected Pew Commission on Industrial Farm Animal Production, told me, “They have the authority to make these guidelines mandatory; the problem is that it’s regulation by the consent of the regulated.”
I could go on.
This in part explains why millions more are doomed to be sickened by the F.D.A.'s failures. You can blame Congress for inaction, too — shocking, I know. The Preservation of Antibiotics for Medical Treatment Act would require the F.D.A. to review its approvals of antibiotics and cancel them for antibiotics that help breed resistant bacteria; in fact it would put the burden of proof back on the companies, alleviating the workload and contentiousness Taylor seems intent on avoiding. (In fact, if the F.D.A. were truly interested in public health it would be out there lobbying for the passage of PAMTA.) Slaughter has introduced this act four times since 2007, and it’s supported by almost everyone, but it hasn’t passed. One wonders, though, since the F.D.A. is already under court order to do pretty much the same thing, whether even PAMTA would spur them on.
Instead, the F.D.A. has created a “road map for animal pharmaceutical companies to voluntarily revise the F.D.A.-approved use conditions on the labels of these products to remove production indications.” No obligation. And no problem labeling those same drugs as disease-prevention vehicles, as long as those uses are “judicious and appropriate,” says Taylor. Whether you call it growth promotion or disease prevention, the effects are likely to be on labels only, not on public health. (It seems to me that if you prevent disease you promote growth, and vice versa. It also seems to me that if you prevent disease by having healthy growing conditions you don’t need to prevent it with antibiotics.)
And drug companies are O.K. with this new “guidance,” because it’s so benign it won’t affect their bottom lines. In a Wall Street Journal piece, Jeff Simmons, the president of Eli Lilly’s “animal-health division,” was quoted as saying, “We do not see this announcement being a material event.”
The F.D.A. says it “is asking animal pharmaceutical companies to notify the agency of their intent to sign on to the strategy within the next three months.” (There are no provisions for noncooperation.) “These companies would then have a three-year transition process.” In other words, drug companies have three months to “comply” with a voluntary plan to marginally change their labeling, and three years to implement that. Again, if they don’t … sorry, there’s no plan.
Strenuous oversight, huh? During which time industry can figure out how to increase the amount of antibiotics they sell, as long as they don’t label them as growth-promoting. Yet Taylor insists that “this will make a difference for resistance.”
In those three years, something like 69,000 Americans will have died from antibiotic-resistant bacterial diseases; many subsequent deaths may be preventable if rampant use of antibiotics is curbed now. But when insiders talk about the expected percentage decline in antibiotic use as a result of the F.D.A. recommendations, the smart money is on “zero.” And when I asked Taylor, “How much do you anticipate routine antibiotic use declining in the next few years?” he answered, “It’s a fair question but I don’t have an answer for you — we need to work on that.”
It’s depressing. I root for the F.D.A. to do its job, but the power of industry and its anti-regulatory lobby adds up to an apparent unwillingness to put public health above all else. And by phasing this in over three years (by which time we’ll have a new and possibly less supportive president), the agency has bought itself and the industry more time before bowing to the inevitable change in our horrific animal production system.
In fact, the worst thing about the new guidelines may be that they’re seen as a first step, and as such rule out a more meaningful one. (Center for a Livable Future’s Martin said to me, “My fear is now we won’t see anything new for a decade.”) It’s bad news masquerading as good news. The F.D.A. is claiming, “We’re controlling the use of antibiotics in animal production!” But it’s more like Congress declaring, “We’re raising the minimum wage!” and then appending “...by 10 cents an hour. And we’ll review the impact of this monumental change in three years!”
I should point out that some of my favorite antibiotic-overuse critics are more optimistic, among them the former F.D.A. head David Kessler, who was quoted in these pages as saying, “This is the first significant step in dealing with this important public health concern in 20 years,” and Laura Rogers, a director at the Pew Charitable Trusts, who told me, “These criteria represent a meaningful shift in the agency’s public policy, and bode well for future action.” (“That said,” Rogers added, “we are concerned that antibiotics will still be used for disease prevention, possibly in place of growth promotion.”)
Rogers is admirably diplomatic, but I agree more closely with Representative Slaughter, who wrote, “Sadly, this guidance is the biggest step the F.D.A. has taken in a generation to combat the overuse of antibiotics in corporate agriculture, and it falls woefully short of what is needed.”
It’s also worth noting that the F.D.A. has drafted (that means it’s not even yet a recommendation) a “directive” that would require that veterinarians supervise antibiotic use. Make that final and make that mandatory — as the agency is threatening to do if these voluntary guidelines don’t work — and we might be getting somewhere. But the best-case scenario is that within three years some or even all growth-promotion claims will have been dropped and the use of antibiotics will be approved by veterinarians — many of whom have jobs that will depend on approving just such uses. I see no reason to be encouraged. It may truly be worse than nothing, or it may simply be a delay we can ill afford.
Public safety is the F.D.A.'s job, and they’re doing it badly. What’s needed here is a drastic reduction in the use of antibiotics, now, and few people think these recommendations are going to do that. As the Union of Concerned Scientists’ Mellon said to me, “This recommendation involves voluntarily giving up making money in the interest of public safety. Who does that in the United States? No one.”
What can we do? Push for labeling, for one thing: “Raised without antibiotics” (period) is a label we could pay more attention to. And push our markets to carry more truly antibiotic-free meat, and buy it. Organic meat is another obvious solution. I’ll get to strategies like these in another column. But as Slaughter said, “I’m persuaded now that the only thing we can do is get an outcry from the public.” Make some noise, people.
House of Representatives
Summary: Delivering Antimicrobial Transparency in Animals (DATA) Act
Committee on Energy and Commerce Minority Staff
The Delivering Antimicrobial Transparency in Animals (DATA) Act would increase our knowledge of how antibiotics and other antimicrobials are used in food-producing animals. Specifically, the bill will:
• Require drug manufacturers to obtain and provide better information to FDA on how their drugs are used by determining (or estimating) the amounts of their drugs used in each food-producing animal for which they are approved (e.g., cattle, swine, and poultry);
• Improve the timing and quality of the data that FDA publicly releases
Additionally, the DATA Act will, for the first time, require large-scale producers of poultry, swine, and livestock to report data on the medicated feeds provided to their animals. The bill would require these producers to submit data to FDA detailing the type and amount of antibiotics and other antimicrobials contained in the feed they use. If the medicated feed is under a Veterinary Feed Directive (VFD), more detailed information must be provided to FDA, including the quantities, dosages, and duration of time the medicated feeds were provided to the animals.
The DATA Act requires the Secretary of Health and Human Services to coordinate with the Secretary of Agriculture to improve the collection of data on the use of antibiotics and other antimicrobial drugs in or on food producing animals.
The DATA Act also would require FDA to finalize within 180 days its guidance for drug sponsors wishing to comply with FDA’s recommendations for judicious use of medically important antibiotics and other antimicrobial drugs in animals. It would require GAO in three years to evaluate the FDA voluntary approach to reducing or eliminating injudicious use of antimicrobials in animals, and the effectiveness of FDA’s antimicrobial data collection process.