As I have previously posted, antibiotic resistance is a major public health issue and livestock production contributes to the problem.  The FDA is currently considering guidelines, but they are rather weak. While I used text from Healthy Food Action, I did add information and trust that they will have no concerns with my reposting it here. FYI, the guidelines are under consideration until July 12, so comment ASAP!

Please send your thoughts to:
Commissioner Hamburg and the Center for Veterinary Medicine
Food and Drug Administration
1401 Rockville Pike Suite 200N
Rockville, MD 20852-1448 US
AskCVM@fda.hhs.gov, margaret.hamburg@fda.hhs.gov

Antibiotic Use in Livestock: Draft Guidelines

Dear Dr. Hamburg,

As the CDC has predicted, antibiotic resistance is exacting a huge
toll, in terms of patient suffering and death, as well as the
burgeoning cost of treating resistant infections. The FDA has
recognized that antibiotic resistance is a human health concern since
1977.

Under this Administration, the FDA has recognized 80% of all antibiotics in the U.S. are sold for farm use, a notable part of antibiotic overuse that poses a threat to public health. As a nutritionist, I’m terribly concerned at the negative impact our food production is having on the future of medicine.

While I applaud FDA’s vow to address this problem, I have serious concerns about an entirely voluntary approach, as laid out in Draft Guidance 213 (FDA-2011-D-0889) and Veterinary Feed Directive; Draft Text for Proposed Regulation (Docket No. FDA-2010-N-0155). In essense, the FDA’s proposal is to ask pharmaceutical companies to volunteer to give up their FDA approval to sell antibiotics for uses in food animals that the FDA deems injudicious – including non-therapeutic uses like growth promotion. Because the stakes for public health could not be higher, we are disappointed the FDA has chosen not to use its legal authority to mandate reductions in antibiotic overuse in favor of a time-consuming, voluntary program that may or may not work. As previous calls by the public and NGOs for voluntary withdrawls and shifting approaches to therapuetic treatments only have shown little success, there is little reason to believe this proposed guidance would decrease unnecessary use.

While I strongly a support mandatory approach, there are key elements that would improve the proposed guidelines.

• First, given that the use of the same antibiotic for preventive or for growth promotion under current labels can be nearly indistinguishable from therapuetic uses, I am concerned that the draft Guidance if finalized would enshrine the substitution of preventive uses for growth promotion and other “production” uses – in other words, any change in the amounts and mode of how antibiotics are actually used on the farm would only be cosmetic.

We therefore urge that in its final Guidance the FDA should announce it expects pharmaceutical companies to give up label claims for any routine use in food animals of antibiotics for disease prevention as well as for growth promotion. That is because in terms of the risk to public health, there is little grounds for distinguishing between these long-term, low dose use of antibiotics (i.e. routine uses), whether for growth promotion, feed efficiency, or disease prevention. Successful growers can maintain hygiene and reduce disease through strict production protocols in nearly all cases. This additional protection in the guidance would in no way interfere with reasonable, judicious and non-routine use of antibiotics for flocks or herds of animals that are sick.

• Second, the draft language in Guidance #213 appears to open the door for standard of safety to be employed for these new approvals to replace growth promoters that will be weaker than the safety standard contained in the FDA’s preexisting guidance document. We therefore urge that this draft language be dropped and that it be made explicit that all new antibiotic approvals be evaluated for safety using the current method described in FDA’s already final Guidance #152.

• Third, companies volunteering to participate in the proposed process will have 3 years to negotiate with the FDA over which antibiotic uses or claims they are willing to abandon and which new claims the FDA will approve to replace them. However, the FDA will not even commence negotiations until it finalizes new related rules for antibiotics in feed (Veterinary Feed Directive Rules), a process which itself could take an additional 3 years or more. The proposed approach in Guidance #213, in other words, could require 6 years or more before any real reductions in antibiotic overuse in industrialized livestock and poultry production are realized. FDA should make frequent reports to the public on the progress of the voluntary plan including publishing annually the number of claims companies intend to give up and the number of new claims they seek as replacements under Draft Guidance #213.

Finally, I urge the FDA to embrace public transparency. Because FDA’s plan is dependant on voluntary action by industry, because it could well take six to eight years to know the outcome of the industry-agency negotiations, and because the negotiations between the FDA and industry will held behind closed doors, it is doubly important that the FDA let the public know what its plans are for monitoring antibiotic use and resistance rates to measure the effectiveness of its action. If its measures are not being effective in reducing antibiotic use, the FDA should tell the public how and when stronger measures will be put into place.

Antibiotic resistance is a serious public health problem that grows worse every day. European countries, including Denmark, have eliminated the routine use of antibiotics in livestock production and seen dramatic decreases in antibiotic resistance without harmful impacts on the livestock industry. In Denmark, resistance to one antibiotic dropped from 90% to 25% in a short five years. We ask that the FDA not only recognize the gravity of the problem, but also do what is necessary to make sure we Americans do not lose the benefits of these life-saving medicines. Thank you for your consideration.

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