Maryn McKenna

Journalist and Author

More On Court Ordering FDA Hearings on Farm Antibiotics

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Since I posted last night on the judge’s order that the Food and Drug Administration examine the safety of farm antibiotics — via hearings that the Food and Drug Administration scheduled, but never held, back in 1977 — a lot has happened. Here’s a round-up.

The Natural Resources Defense Council, lead plaintiffs in the suit (with the Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen and Union of Concerned Scientists) has put up a press release/explainer, accompanied by a blog post written by lead attorney Avinash Kar.  (Correction: The lead attorney is Jen Sorenson.) Key quote from Kar:

The judge’s opinion makes it clear that FDA’s voluntary approach—letting the industry police itself—does not satisfy its legal obligations. FDA must schedule hearings to let drug manufacturers make their case, and if the drug manufacturers cannot prove that the use of antibiotics in animal feed is safe, FDA must withdraw approval for those drug uses.

Kar’s comment to me: “We think this is a great step forward for public health. For 35 years, FDA has basically sat on the sidelines, mostly letting the industry police itself. In that time we have seen a massive rise in the occurrence of antibiotic-resistant bacteria. This means we now will ensure that we preserve these lifesaving medicines for those who need them most.”

I asked the press office this morning at the Center for Veterinary Medicine, the FDA division named in the order, if the agency has a response yet. They said: “We are studying the opinion and considering appropriate next steps.”

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Breaking News: Judge Orders FDA to Examine Safety of Ag Drugs

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Here’s breaking news that I’ve learned about. The significance is going to unfold over the next 24 hours and more, and when it does, I will update. (Update: Overnight, a lot came out about this, so I’ve wrapped it all into a new post here.)

Here are the basics:

A district judge in New York has ruled in favor of a coalition that sued the Food and Drug Administration in order to compel the agency to follow through on its 35-year-old attempt to exert control over antibiotics in animal feed known as “growth promoters” — tiny doses of antibiotics delivered in feed and water that are believed to stimulate the evolution of antibiotic-resistant organisms.

Technically, Magistrate Judge Theodore H. Katz has granted the groups’ motion for summary judgement, and denied the FDA’s request that the suit be dismissed.

The decision, filed this afternoon, does not compel the FDA to ban growth-promoter (or “feed efficiency”) use of antibiotics. What it does appear to do, though, is require the FDA to follow through on a process that it began in 1977, when the agency was so concerned over the safety of using penicillin and tetracycline drugs in livestock feed that it called hearings to examine withdrawing its approval of using the drugs in animals.

Because of pressure, largely from certain Congressmen, those hearings were never held.

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FDA Documents Show Agency Once Strongly Opposed Farm Antibiotic Overuse

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The use of antibiotics and sulfonamide drugs, especially in growth promotant and subtherapeutic amounts, favors the selection and development of single and multiple antibiotic-resistant and R-plasmid-bearing bacteria.

Animals that have received either subtherapeutic and/or therapeutic amounts of antibiotic and sulfonamide drugs in feeds may serve as a reservoir of antibiotic resistant pathogens and non-pathogens. These reservoirs of pathogens can produce human infections.

The prevalence of multi-resistant R-plasmid-bearing pathogenic and nonpathogenic bacteria in animals has increased and has been related to the use of antibiotics and sulfonamide drugs.

Organisms resistant to antibacterial agents have been found on meat and meat products.

If you give the text above a close read, you might think it was written by Mark Bittman or Tom Philpott or Tom Laskawy, or me — or any of the small number of journalists who focus on the safety and policy perils of giving scarce antibiotics to confinement-raised farm animals. After all, what it says is what any of us would say: Routine administration of antibiotics to livestock spurs the emergence of drug-resistant bacteria that move through the food chain, threaten human health, and lend their DNA to yet other bacteria, increasing the reservoir of resistance in a dangerous and untracked manner.

As it happens, though, the text above wasn’t written by any of us. It was written by the Food and Drug Administration, the FDA.

Yes, the FDA — the federal agency that, as I wrote last Friday, has just backed off a 34-year attempt to assert regulatory control over “growth promoter” antibiotic use, opting instead for voluntary self-policing by the agricultural and pharmaceutical industries.

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News: FDA Won't Act Against Ag Antibiotic Use

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With no notice other than a holiday-eve posting in the Federal Register, the US Food and Drug Administration has reneged on its long-stated intention to compel large-scale agriculture to curb over-use of agricultural antibiotics, which it had planned to do by reversing its approval for putting penicillin and tetracyclines in feed.

How long-stated? The FDA first announced its intention to withdraw those approvals in 1977.

From the official posting:

The Food and Drug Administration (FDA or the Agency) is withdrawing two 1977 notices of opportunity for a hearing (NOOH), which proposed to withdraw certain approved uses of penicillin and tetracyclines intended for use in feeds for food-producing animals based in part on microbial food safety concerns.1 … (1FDA’s approval to withdraw the approved uses of the drugs was based on three statutory grounds: (1) The drugs are not shown to be safe (21 U.S.C. 360b(e)(1)(B)); (2) lack of substantial evidence of effectiveness (21 U.S.C. 360b(e)(1)(C)); and (3) failure to submit required reports (21 U.S.C. 360b(e)(2)(A)).)

There is a lot of background to this, but here is the takeaway: For 34 years, the FDA has been contending that administering small doses of antibiotics to healthy animals is an inappropriate use of increasingly scarce drugs — a position in which it is supported by organizations as mainstream as the American Medical Association. With this withdrawal, it backs away from the actions it took to support that assertion — which may indicate there will be no further government action on the issue until after the 2012 election.

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EU Parliament Votes To Oppose Most Farm Antibiotic Use

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A quick post, because I’m on a ferocious deadline, but still can’t let this news go by. In a vote that’s non-binding but high profile and influential, the European Parliament has resolved to end “prophylactic use” of antibiotics in farming, and to prevent any “last resort” antibiotics from being used in animals, in order to keep resistance from developing so that the drugs will still be effective in human medicine.

This is a significant development. The European Union has already banned “growth promotion,” the use of micro-doses of antibiotics that cause meat animals to fatten more quickly. What the Parliament is doing here is asking the European Commission, the EU’s law-making body, to add “disease prevention” use to the ban. That’s the delivery of treatment-strength doses of antibiotics to all animals on a farm in order to prevent their becoming ill as a result of the confinement conditions in which they are held. It accounts for a substantial portion of the antibiotics used in agriculture, and is a major driver of the emergence of antibiotic-resistant organisms.

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Is China Banning Growth Promoters And Do They Mean It?

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A tantalizing prospect surfaced yesterday. The Institute for Agriculture and Trade Policy in Minneapolis tweeted a link to a Sept. 13 story from an online agricultural trade journal that said, in its entirety:

China’s Ministry of Agriculture has announced a forthcoming ban on antibiotics as growth promoters in animal feed. The ban is supported by the academic community, which believes that without antibiotics in animal feed, the health of animals will be better promoted, microbes’ resistance to antibiotics will be lowered and food will become safer to eat. Recent statistics show that in 2006 China produced 210,000 tons of antibiotics, and 97,000 tons were added to animal feed. Today it is estimated that 400,000 tons are produced annually.

So, first: If this story is accurate, it would be huge news. But, second: The story lists no sources and is almost a month old; in that month, there has been no other major coverage of this decision that I can find — which means a responsible reporter (which I try to be) needs to do some digging rather than pushing the link along.

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Growth Promoters: If You Can't Convince Them, Sue Them

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A little less than a year ago, the Food and Drug Administration took a step that, depending on your point of view, was either far too activist or nowhere-near-enough-but-good-try: It proposed, in a draft document, that the agricultural industry voluntarily restrict its use of growth-promoting micro-doses of antibiotics.

It was a significant step. The FDA has been trying to restrict subtherapeutic use of antibiotics in livestock since the 1970s because of the practice’s clear contribution to the development of antibiotic resistance, and had always been defeated. At the same time, it was far from bold: The proposal was made in a draft document that would be made final at some unspecified future date, and that when it became final would have behind it no force of regulation or law. (Here’s my long discussion from last year of the context and history of FDA’s move.)

And there things rested, while the FDA’s docket reportedly filled up with thousands of comments from both sides of the issue. The document — formally, Draft Guidance #209, Judicious Use of Antimicrobial Drugs in Food-Producing Animals — is scheduled to be finalized sometime before the end of this year. But in its draft form, it excited abundant opposition, and the administration official who seemed to be leading the charge on it, memorably suggesting, “We have the regulatory mechanisms and the industry knows that,” has left the FDA for a state-government job.

Clearly, things aren’t moving very fast. So today, a coalition of nonprofit groups attempted to get the issue jump-started: They sued.

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News break: FDA head promises "very serious scrutiny" of farm antibiotics

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Since July, the Food and Drug Administration has been moving — quietly and cautiously, but moving — to raise the stakes in its long and so-far unsuccessful battle to rein in overuse of antibiotics in agriculture. For those new to the topic, this is the use of antibiotics not in treatment-sized doses, to cure disease in farm animals, but in smaller doses to prevent disease or simply to make the animals gain weight faster so they can raised more efficiently and sold off more quickly than they would have otherwise.

There are decades of research by now, demonstrating that this contributes to the development of antibiotic-resistant organisms on farms that then move off harms and threaten human health. It’s not really a scientific question any longer; it’s a question of economics and politics.

(For a long discussion of what the FDA is proposing — and how much force it will, or won’t, have — see this post — at SUPERBUG’s earlier location, because we haven’t yet moved over all the archives.)

Yesterday, FDA Commissioner Dr. Margaret Hamburg gave a speech at the National Press Club at which she raised this issue and made some intriguing remarks. The overall point of the speech (see this AP article) was to promise increased investment and modernization — but she raised both the problem of antibiotic resistance generally and, in answer to a question, the problem of antibiotic use in farming.

First, here’s what she said generally about resistance (my transcription from CSPAN’s video above, starting at about 7:00):

There is increasing alarm about the problem of antibiotic resistance, and we worry with good cause. Today, antibiotic resistance mechanisms have been reported for virtually all known antibacterial drugs currently available for clinical use, which affects everything from global infectious diseases to ear infections in school children to staph infections in locker rooms. People actually talk today about a potential return to the, quote, pre-antibiotic era, unquote, where we no longer have effective tools to treat serious infectious disease. Clearly we must encourage more judicious use of these important drugs through improved infection control,  rational prescribing and better patient compliance.

But even if we improve these practices, resistant bacteria will continue to develop no matter what. We need new and better drugs and we need them now. Yet the research and development pipeline is distressingly low. The number of newly approved antibiotics, not just new formulations of previously existing drugs, has fallen steadily since the 1980s, and the range of new antibiotics in distribution is limited in terms of the types of classes of new antibiotics available and the diseases they can treat.

And here’s what she said about farm use, in response to a question (starting at about 31:00):

There historically has been a very considerable use of antibiotics as part of animal husbandry and also agriculture. I think that for many years individuals and organizations in public health and medicine have raised those very concerns, about what is the impact of the use of antibiotics in animal populations on human health and the availability of effective antibiotics to treat disease. We are in the midst of very serious scrutiny of these issues and we have made recommendations in support of judicious use of antibiotics. Nobody wants to deny antibiotics to animals that need medical treatment. But the use in certain preventive contexts, where it is not clearly medically indicated, is of growing concern,. And it is an area that, working with our partners in government, both the CDC and the USDA and others, that we are taking a very serious look at. (Emphasis mine.)