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Urge FDA to Do More to End Antibiotic Overuse in Industrialized Livestock

Leading medical and public health groups have warned that the overuse of antibiotics contributes to the development of and public health threat from antibiotic resistant infections. FDA data indicate 29 million pounds of animal antibiotics are sold annually, more than fourfold the volume of human antibiotics.

The FDA could act to remove unsafe animal drugs from the market, by directly using its authority (under the Food Drug and Cosmetic Act) to cancel approval for them. But that’s not the path the Agency’s taken.

In recently issued draft Guidance, the FDA instead lays out a voluntary approach for pharmaceutical companies. Essentially, the FDA asks these companies to volunteer to give up FDA approval – and therefore profits – from sale of antibiotics intended for certain routine uses that the Agency considers to be injudicious – including non-therapeutic uses like growth promotion. Pardon us if we are skeptical.

Join us in urging Dr. Hamburg, the FDA Commissioner, to take stronger action so that life-saving antibiotics will no longer be overused on industrialized farms. Act now. The deadline for FDA to receive comments is July 12th.

Use the letter below as a template, but to increase its impact, please personalize the message.

Subject:

Your Letter:

Dear Dr. Hamburg, 
The scourge of antibiotic resistance is exacting a huge toll, in terms of patient suffering and death, as well as the burgeoning cost of treating resistant infections. As a health professional, I’m terribly concerned.

Under this Administration, the FDA has recognized 80% of all antibiotics in the U.S. are sold for farm use and that this represents in part an overuse of antibiotics that poses a threat to public health.

While I applaud FDA’s vow to address this problem, I want to share serious reservations about this entirely voluntary approach, as laid out in Draft Guidance 213 (FDA-2011-D-0889) and Veterinary Feed Directive; Draft Text for Proposed Regulation (Docket No. FDA-2010-N-0155).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.

If this voluntary approach does move forward, however, we urge that the FDA take action to strengthen the draft Guidance as follows:

•	First, given that the use of the same antibiotic for preventive or for growth promotion under current labels can be nearly indistinguishable, 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. 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. We ask that FDA not only recognize the gravity of the problem, but also do what is necessary to make sure we do not lose the benefits of these life-saving medicines.
 
Thank you for your consideration. 
Sincerely,

Commissioner Hamburg

Food and Drug Administration
1401 Rockville Pike
Suite 200N
Rockville, MD 20852-1448
US