Catching up on some news from last week, the U.S. Food and Drug Administration has unveiled a “a voluntary strategy to promote the judicious use in food-producing animals of antibiotics that are important in treating humans.” The goal is to reduce human infections involving drug-resistant bacteria. Background and details on the new policy are after the jump.

For many years, public health advocates have called for limits on the use of antibiotics in livestock production. Criticism has focused on the “non-therapeutic” use of antibiotics–that is, giving animals continual low doses of antimicrobials to prevent disease or to spur growth, as opposed to full-strength short courses of antibiotics to treat illnesses. Extensive research has suggested that the overuse of antibiotics (in humans and cleaning agents as well as in animals) is causing more frequent human infections with bacteria that are resistant to antibiotics. This concern is not new: way back in 1977, the FDA issued a rule that “would have banned non-medical use of penicillin and tetracycline in farm animals.” The government did not enforce that rule.

The Pew Campaign on Human Health and Industrial Farming links to a lot of research about this issue on its Save Antibiotics website. After a two-year study of livestock farming in the U.S., the Pew Commission on Industrial Farm Animal Production recommended phasing out and then banning “the nontherapeutic use of antimicrobials in food animal production.” (pdf)

The livestock industry and its surrogates dispute the Pew report’s findings. As an example of their case, I enclose at the end of this post excerpts from a floor statement Senator Chuck Grassley delivered in September 2009.

Early in President Barack Obama’s term, administration officials seemed inclined to act on the use of antibiotics in farming. In July 2009, a senior FDA official announced that the Obama administration “supports ending the non-therapeutic use of seven antibiotics for growth promotion and feed efficiency.” But the federal government’s follow-through has been slow as agricultural interest groups strongly opposed any mandatory limits on antibiotics. In January of this year, a federal court ordered the FDA to take steps toward implementing the 1977 rule limiting certain drugs in farm animals’ feed.

Earlier this month, the FDA issued the final version of a new rule banning “extralabel” use of cephalosporin drugs in cattle, swine, chickens and turkeys. Cephalosporins are “a critical class of antibiotics that includes drugs like Cefzil and Keflex, which are commonly used to treat pneumonia and strep throat.” The Pork Network summarized the new restrictions for pork producers:

Extralabel use is when a drug is used in a manner other than what is designated on a specific product’s label.  FDA offers these guidelines as prohibited uses:

* Using cephalosporin drugs at unapproved dose levels, frequencies, durations or routes of administration;

* Using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in that species (for example, cephalosporin drugs intended for humans or companion animals);

* Using cephalosporin drugs for disease prevention.

Cephalosporin drugs may still be used as designated on a product’s label for the treatment of a specific disease within a species.  

What this means for swine veterinarians and pork producers is that, “effective immediately, cephalosporins cannot be prescribed for use in an extralabel manner except for indications not included on the label and then only at the dose, frequency, duration and route of administration described on the label,” points out the American Association of Swine Veterinarians. “Also, cephalosporins intended for use in humans or companion animals are prohibited for use in swine as is any use for disease prevention.”

That prohibition applies to only one class of drugs. The FDA took a less stringent approach to the broader issue:

Farmers and ranchers will for the first time need a prescription from a veterinarian before using antibiotics in farm animals, in hopes that more judicious use of the drugs will reduce the tens of thousands of human deaths that result each year from the drugs’ overuse.

The Food and Drug Administration announced the new rule Wednesday [April 11] after trying for more than 35 years to stop farmers and ranchers from feeding antibiotics to cattle, pigs, chickens and other animals simply to help the animals grow larger. […]

Michael Taylor, the F.D.A.’s deputy commissioner for food, predicted that the new restrictions would save lives because farmers would have to convince a veterinarian that their animals were either sick or at risk of getting a specific illness. Just using the drugs for growth will be disallowed and, it is hoped, this will cut their use sharply. The new requirements will also make obtaining antibiotics more cumbersome and expensive.

I enclose below a Q and A from the FDA’s website explaining the new “voluntary strategy to promote the judicious use in food-producing animals of antibiotics that are important in treating humans.” Some public health advocates aren’t impressed:

Caroline Smith DeWaal of the Center for Science in the Public Interest criticized them as “tragically flawed” because they relied too much on voluntary industry efforts. […] Ms. DeWaal of the science center said that she believed the industry would not follow through on its promises but would instead await the next election in hopes of an administration friendlier to its interests. She condemned the F.D.A. for failing to restrict these drug uses outright. “The agency is afraid to use its authority,” she said.

The Atlantic blog published a critique of the FDA guidelines by Dr. Robert S. Lawrence, professor of Environmental Health Sciences, Health Policy, and International Health at the Johns Hopkins Bloomberg School of Public Health. I recommend reading his whole commentary, but here’s an excerpt:

The FDA missed the point, however. While the documents call for ending the use of antibiotics to make animals grow faster, they endorse the continued use of these drugs to compensate for overcrowded and unsanitary conditions and prevent disease at the industrial operations that produce most food animals in this country. The preventive or “prophylactic” use of antibiotics is similar to their use for growth promotion, involving comparable low doses that are equally culpable in the development of antibiotic resistance.

The FDA calls preventive use “necessary to assure animal health.” Left unaddressed is what makes this use “necessary.” The industrial model of food animal production increases animals’ exposure to bacterial pathogens and weakens the animals’ immune system through overcrowding and the suppression of normal animal behaviors, leaving them susceptible to infections without the continuous administration of low doses of antibiotics. Rather than ban preventive use of antibiotics to require the industry to raise animals in a manner that assures both public and animal health, the guidance document accommodates an industry that undermines both. […]

If antibiotics could no longer be used for disease prevention, the food animal production industry would be forced to reform its production practices to raise healthy animals in other ways. The preventive use of antibiotics would no longer be “necessary.” By eliding this fact in its guidance documents, the FDA has built public health policy around the needs of the industry rather than require the industry to reform itself to assure both human and animal health.

The guidance document defines disease prevention as follows: “the administration of antimicrobial drugs to animals, none of which are [sic] 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.

I have sought comment on the FDA’s new voluntary guidelines from all the Iowans in Congress and from Governor Terry Branstad. So far the communications directors for Branstad and Representative Leonard Boswell (D, IA-03) have indicated that they are unlikely to comment on this policy. I’m surprised that Boswell hasn’t reacted publicly to the FDA guidelines. In July 2009, he testified before the House Rules Committee in support of allowing livestock farmers to continue the non-therapeutic use of antibiotics. Click here to read that testimony, which closely tracked industry talking points. In fact, Boswell told his Congressional colleagues, “I hope as a farmer and user of antibiotics I have offered you some insight into the livestock industry’s perspective.”

I will update this post if I hear back from anyone in Iowa’s Congressional delegation. Meanwhile, share any relevant thoughts in this thread.

FDA statement on the new strategy on antimicrobial resistance:

1. What is FDA doing?

The Food and Drug Administration (FDA) is implementing a voluntary strategy to promote the judicious use in food-producing animals of antibiotics that are important in treating humans. The goal of the strategy is to protect public health and help curb the development of antimicrobial resistance and in turn help to reduce the number of infections in humans that are difficult to treat because existing antibiotics have become ineffective.

2. What are antimicrobial drugs and antimicrobial resistance?

“Antimicrobial drugs” include all drugs that work against a variety of microorganisms, such as bacteria, viruses, fungi, and parasites. “Antimicrobial resistance” is when bacteria or other microbes become resistant to the effects of a drug after being exposed to them. This means that the drug, and similar drugs, will no longer work against those bacteria. If resistant bacteria enter the food supply, drugs normally used to treat people infected with those bacteria may not work.

3. Why is FDA taking this action?

It is well established scientifically that all uses of antimicrobial drugs, in both humans and animals, contribute to the development of antimicrobial resistance, and that this is an important public health concern. Experts agree that antimicrobial drugs must be used “judiciously” in both animal and human medicine to slow the development of resistance.

4. What is “judicious use” and what are FDA’s recommendations?

“Judicious use” is using an antimicrobial drug appropriately and only when necessary; Based on a thorough review of the available scientific information, FDA recommends that use of medically important antimicrobial drugs in food-producing animals be limited to situations where the use of these drugs is necessary for ensuring animal health, and their use includes veterinary oversight or consultation. FDA believes that using medically important antimicrobial drugs to increase production in food-producing animals is not a judicious use.

5. Why did FDA decide to do this now?

FDA has worked with many stakeholder groups and the U.S. Department of Agriculture (USDA) to develop a strategy that will be successful in reducing antimicrobial resistance while minimizing adverse impacts on animal health and disruption to the animal agricultural industry. In June 2010, FDA released a draft guidance document explaining its recommendations for change and in the interim period sought and received input from various stakeholders, including the animal pharmaceutical industry, animal feed industry, veterinary and animal producer communities, consumer advocacy groups and USDA. Today’s announcement is the culmination of this effort to develop a workable path forward.

6. What specific steps is FDA taking?

FDA is taking a three-pronged approach:

First, it is issuing an updated, final version of guidance for industry, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals (Guidance #209). The guidance establishes the framework for phasing out production uses of antimicrobials that are important in treating humans and phasing in veterinary consultation or oversight of the remaining therapeutic uses of such drugs. The purpose of this guidance is to: (1) Discuss FDA’s public health concerns about how certain uses of medically-important antimicrobial drugs in food-producing animals may impact antimicrobial resistance; (2) Summarize some of the key reports and scientific literature on the use of antimicrobial drugs in animal agriculture; and (3) Outline FDA’s recommendations on how to make sure that medically-important antimicrobial drugs are used judiciously in food-producing animals and remain effective for animals and people.

Second, FDA is issuing for public comment draft guidance (Guidance #213) that will guide drug companies seeking to voluntarily revise product labels to (a) remove the use of antibiotics for production uses such as feed efficiency and growth promotion from their FDA-approved product labels; (b) adding, where appropriate, scientifically-supported disease prevention, control, and treatment uses and (c) changing the marketing status to include veterinary oversight or consultation. FDA is inviting comment on this draft.

Third, the agency is inviting comment on the Veterinary Feed Directive (VFD) regulation that governs veterinary authorization of the use of certain drugs in animal feed. VFD drugs are animal drugs intended for use in or on animal feed which are limited to use under the professional supervision of a licensed veterinarian. Changes are needed to modernize and streamline VFD procedures in order to facilitate phasing in greater veterinary oversight of the use of antibiotics in animal feeds in a manner that is both practically feasible and efficient.

7. Which antimicrobial drugs used in food-producing animals are the focus of FDA’s strategy?

The voluntary strategy is primarily focused on medically important antimicrobial drugs that:

Were approved prior to the issuance of Guidance 152, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern, was published in October 2003.

Are used in food-producing animals to increase feed efficiency and promote growth;

Are available over-the-counter (OTC), and therefore, can be given without a veterinarian’s involvement; and

Are given continuously through the feed or water to entire herds or flocks of animals.

A list of antimicrobial drugs FDA considers medically-important can be found in Appendix A of Guidance for Industry #152.

8. How have antimicrobial drugs traditionally been used in food-producing animals?

Antimicrobial drugs that are FDA-approved for use in food-producing animals are normally used to:

Treat or control an on-going infectious disease;

Prevent an infectious disease before an outbreak occurs; or

Increase production by making the animal gain weight faster and by improving the animal’s ability to convert the food it eats (improved feed efficiency). With these agricultural production uses, typically no disease is present and no outbreak is anticipated to occur. These drugs are given to animals to enhance the production of animal-derived food products.

9. Why is the involvement of a veterinarian important?

Most of the antimicrobial drugs approved for use in food-producing animals in feed or water are over-the-counter products. Including veterinary oversight or consultation when these drugs are used in food-producing animals is an important way to ensure judicious use. This is because judicious use involves accurately identifying bacterial disease that is present or likely to be present and selecting the suitable antimicrobial drug. In the case of prevention, judicious use includes a consideration of relevant factors for determining the risk of a specific bacterial disease. FDA understands that veterinary oversight or consultation varies due to many factors, such as geographic location of the farm and different animal production methods. Sometimes, veterinarians directly diagnose and treat animals, while other times, they periodically visit and consult with an animal producer to customize a disease management protocol for that producer’s herd or flock.

10. How will greater veterinary oversight help ensure that the use of medically important antimicrobial drugs for disease prevention purposes is appropriate and judicious? Can you give an example?

We believe that veterinary expertise can determine whether the use of antimicrobials for preventive purposes is appropriate in a particular situation and, thus, would be considered judicious. We also believe that veterinarians are uniquely qualified to determine which specific diseases or conditions are likely to be present and to determine which specific approved drug or combination drug is most appropriate, based on factors such as the mode of antibacterial action, drug distribution in specific tissues, and the duration of effective drug levels at the site of infection. From FDA’s standpoint, the administration of antimicrobial drugs to animals when a veterinarian determines that there is a risk of a specific disease based on the presence of risk factors such as the stress of transport, environmental factors, or weaning, would be considered judicious use for prevention. For example, if a veterinarian determines, based on the client’s production practices and history, that a group of weaned beef calves arriving at a feedlot in bad weather after a lengthy transport is likely to develop an infection, preventively treating this group with an antimicrobial approved for prevention of that bacterial infection would be considered a judicious use. On the other hand, FDA would not consider administration of a drug to apparently healthy animals in the absence of any information that such animals were at risk of a specific disease to be a judicious use for prevention.

11. How will FDA implement the recommendations for judicious use?

FDA wants the recommendations to be implemented in a way that protects the health of animals and people. FDA does not want the recommendations to negatively impact animal health or disrupt the animal agriculture industry. FDA recognizes the need to collaborate with the animal health and animal producer communities on strategies for minimizing animal health impacts or industry disruption that may be associated with the implementation of changes by animal drug sponsors to voluntarily align the use conditions of affected drug products with the principles outlined in guidance #209.

12. When will FDA implement these recommendations?

Upon issuance of the final version of guidance #213, FDA intends to monitor the progress of its strategy for the voluntary adoption of the changes outlined, including the progress of measures intended to facilitate an orderly and minimally disruptive transition. After 3 years, FDA intends to evaluate the rate of voluntary adoption of the proposed changes across affected products. The agency will consider further action as warranted in accordance with existing provisions of the FD&C Act for addressing matters related to the safety of approved new animal drugs.

Excerpt from floor statement by Senator Chuck Grassley, September 29, 2009. Grassley was responding to this Time magazine article by Bryan Walsh about the “real cost of cheap food.”

Mr. Walsh cites the PEW Commission on Industrial Farm Animal Production in his analysis of why animals treated with antibiotics produce meat unsafe to eat.  However, the American Veterinary Medical Association responded to the PEW report with a lengthy report of their own which the author conveniently fails to mention.  Perhaps because the AVMA study said quote “A scientific human/animal nexus, connecting antimicrobial treatments in animals with food borne or environmentally contracted human disease, has not been proven.”

Livestock producers take very seriously their responsibility to provide safe and abundant food to the general public. Dairy, poultry, and livestock farmers have made a voluntary committment to using antibiotics responsibly. By developing responsible-use guidelines, these industries have proactively taken steps to safeguard both human and animal health.

On issue after issue I’ve worked on my main priority is that the policy decisions we make must be based on sound science, not political ideology.  We’ve seen studies that indicate the risk of food borne bacteria on meat increases when antibiotics that help suppress animal disease are removed actually making our food less safe to eat.

We only have to turn to our neighbors across the Atlantic to see how a ban on antibiotics has played out. The European Union made a decision to phase out the use of antibiotics as growth promoters over 15 years ago and in 1998 Denmark instituted a full voluntary ban which in 2000 became mandatory.

After the ban was implemented in 1999, pork producers saw an immediate increase in piglet mortality and post-weaning diarrhea. Dr. Scott Hurd, a former U.S. Department of Agriculture Deputy Under Secretary for Food Safety and professor at Iowa State University College of Veterinary Medicine released a study which shows that when pigs have been sick during growth, that they will have a greater presence of food-safety pathogens on their carcasses when slaughtered.

If this ban had resulted in improvements to public health, suffering consequences like piglet mortality would make sense, but the science does not back that positive improvements in public health has occurred due to the Denmark ban. In fact, the World Health Organization in 2002 released a study on antimicrobial resistance and could find no public health benefit from the Denmark ban.

It’s true that overall use of antibiotics in Denmark has declined, but there has been a significant increase in the use of therapeutic antibiotics which are used to treat and control disease. I think an interesting statistic is that in 2009 the use of therapeutic antibiotics in Danish pigs is greater than what was used to prevent disease and promote growth prior to the ban in 1999.  Not hard to believe if you look at the science, which Mr. Walsh conveniently ignores.

A 2009 Iowa State University study estimated production costs would rise by $6 per pig in the first year of a prohibition if a similar ban was imposed in the United States as Denmark.  Over 10 years the cumulative cost to the U.S. pork industry would exceed $1 billion.  This would all be on top of the estimated $4.6 billion U.S. pork producers have lost since September 2007 due to the perfect storm of events in the industry.