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What FDA’s new antibiotics strategy means for livestock farmers
Farmers who use antibiotics in food producing animals are encouraged to submit comments regarding a new Food and Drug Administration (FDA) proposal.
The FDA is targeting 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.
Ultimately, the agency wants to phase out production uses and phase in veterinary oversight of antibiotics for food producing animals.
What could change?
FDA believes antibiotics that are determined to be “medically important” to humans should not be used any longer in animal feed for production uses such as growth promotion. FDA did state that antibiotics used for disease prevention, control and treatment are therapeutic applications and essential to protect animal health and as such those label claims should not be affected by the new policy.
The agency said it would work with drug companies to voluntarily phase out the use of antibiotics for production uses (growth promotion) and to apply veterinary feed directive (VFD) standards to the drugs.
This policy means veterinarian oversight will be required to direct product usage for all antibiotics classified for use in human medicine.
While the agency's “guidance” document does not have the force of law, it may be treated as such by FDA. FDA said it is taking a voluntary approach rather than an outright ban on production uses of antibiotics as an outright ban would require hearings in front of a judge for more than 200 drug compounds that would eventually be a lawyer-driven process that could take years to complete.
Pros and Cons
The new rules should relieve concerns about the development of so-called “superbugs” and likely increase consumer confidence in the foods they eat.
However, there are concerns that FDA’s position could disproportionately affect small livestock farmers, have a negative effect on animal health and increase the cost of producing food while not improving public health.
The requirement for Veterinary Feed Directives could be problematic, particularly for livestock farmers in areas that have limited access to veterinarians.
FDA has acknowledged this concern and intends to work collaboratively with the U.S. Department of Agriculture to engage the veterinary community and others to explore strategic approaches (e.g., new models, pilot programs) to address this issue.
Solving the problem?
There is no doubt that antibiotic resistance is a serious and growing healthcare problem. Developing strategies for reducing antimicrobial resistance is critically important for protecting both public and animal health.
However, there is no data to indicate that limiting antibiotic use in livestock decreases human health problems with antibiotic resistance. The Danish experience (Denmark instituted a full voluntary ban on growth promoters in 1998 that was made compulsory in 2000), which many proponents of restricting antibiotic use in livestock cite as a “success,” does not show any improvement in the antibiotic resistance concerns in humans. Additionally, greater amounts of antibiotics were used to treat animal disease in Denmark, although overall use has decreased -- total use declined by 26 percent between 1998 and 2009, while quantities used for therapeutic purposes increased 223 percent.
Furthermore, antibiotics in livestock are currently used carefully in a highly-regulated process. FDA has, and exercises, the authority to review every animal health product, including antibiotics, prior to approval and at periodic intervals after the product is on the market. The FDA can and will deny or limit products that are shown to produce resistance in either animals or people. These regulatory and industry layers of protection are based on years of data collection, and products available to livestock caretakers today have gone through rigorous and continuous scientific testing. The hope is that this would help reduce the number of infections in humans that are difficult to treat because existing antibiotics have become ineffective.
How To Take Action
Label Revisions: 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; (b) adding, where appropriate, scientifically-supported disease prevention, control and treatment uses and (c) changing the marketing status to include veterinary oversight or consultation.
Veterinary Authorization: FDA 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 that 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.
FDA is requesting comment on the following:
- The practical implications of these changes for animal producers, particularly those with smaller operations in remote locations.
- How impacts or disruption to animal producers could be minimized.
- The economic effects that may result from the adoption of the practices set out in the guidances.
- The proposed three-year timeframe for implementation, including impacts on the animal pharmaceutical industry, the feed industry and producers.
Comments regarding the proposed guidance are due July 12 to FDA. Written comments should be submitted to the Division of Documents Management (HFA-305), Food & Drug Administration, 5630 Fishers Lane, Room 1061, Rockville MD 20852. You may also submit your comments electronically. All written comments should be identified with the Docket No. FDA-2010-D-0094.
What does the future hold?
Upon finalizing its guidance document, 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 three 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 Food Drug & Cosmetic Act for addressing matters related to the safety of approved new animal drugs.
Livestock farmers need to be actively engaged with FDA regarding this issue.