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Institute Says FDA's Proposed Antibiotic Guidance is Flawed

Institute Says FDA's Proposed Antibiotic Guidance is Flawed

Cornucopia Institute says FDA's animal antibiotic changes would disadvantage small farmers

Organic policy group the Cornucopia Institute isn't sure the Food and Drug Administration's three-year plan to phase out "medically important" antibiotics for animal use is the best option.

FDA's plan is two-fold approach for limiting animal use of medically important antibiotics: a three-year non-therapeutic use phase-out, and a restriction that requires direct veterinary oversight of therapeutic use.

Cornucopia this week said the plan, which the FDA announced in December, has a few issues. First, the question of compliance among pharmaceutical companies, and second, the question of farmers' ability to use the drugs when they are really needed.

FLAWED POLICY? Cornucopia Institute says FDA's animal antibiotic changes would disadvantage small farmers

Company compliance
Cornucopia charges that some companies which profit from antibiotic sales will simply ignore the FDA's changes.

"The outstanding question is, will this billion-dollar industry make voluntary changes in order to protect the efficacy of important antibiotics used to treat human illnesses, or will pharmaceutical companies resort to a public relations shell game, in order to protect profits in which no material changes really take place?" questioned Rebecca Thistlethwaite, a farm policy analyst with The Cornucopia Institute.

Cornucopia cites a Wall Street Journal interview with Zoetis CEO Juan Ramon Alaix, in which he answers in response to a question regarding the FDA policy:

"We have been partnering with the FDA to ensure anti-infectives in feed are properly used. And we agree with the approach of the FDA to eliminate the growth-promotion indication of certain antibiotics which are relevant for humans in feed. But this will not have a significant impact on our revenues."

Thistlewaite charges that Alaix's reply "implies that Zoetis expects minimal changes in the sales of their animal drugs and that this new FDA guidance will have little effect on the usage of antibiotics in food animals or their sales."

Related: Washington Antibiotic Resistance Scientist Cautious about FDA Plan

Instead, she suggests, FDA should address "crowded conditions that spread drug-resistant pathogens throughout animal herds and flocks." Thistlewaite adds that the changes, which attempt to limit antibiotics for feed efficiency or growth promotion, would simply shift the use of the drugs from growth promotion to disease prevention.


"So-called "sub therapeutic" administration of antibiotics, low doses of the drugs in feed and water to prevent disease, is just as likely to apply selective pressure for antibiotic resistance as sub therapeutic administration designed for production purposes — the same exact problem the FDA is purportedly trying to address with the new restrictions," Cornucopia writes.

Veterinary oversight
Another issue with the new policy, Cornucopia suggests, is that increased veterinary oversight could hurt organic and small farmers who rely on the drugs to treat sick animals.

They point out that while certified as organic, these farms are required to treat animals if they are sick, and immediately remove them from a certified organic herd.

Since the new policy brings therapeutic uses of important antibiotics under the direct oversight of licensed veterinarians, Cornucopia says, small farms may have trouble finding a licensed food animal veterinarian.

"While that move seems reasonable in many ways, similar to requiring a doctor’s prescription to obtain antibiotics for humans, it may disproportionately disadvantage small farmers who don’t have a regular relationship with a veterinarian," Cornucopia suggests.

Andrew Gunther, director of Animal Welfare Approved, a production method certifier, also finds the lack of veterinarians in many parts of the country a serious issue for family farmers, Cornucopia says.

Gunther suggests that the guidance should offer more flexibility, such as allowing "qualified experts like extension agents that could be able to provide animal health advice in addition to veterinarians."

"Since The Cornucopia Institute cares about the livelihoods of independent family farms, local, organic and sustainably managed, there is a legitimate concern that farmers should continue to have access to life-saving medicines for their animals when they need them," Thistlethwaite concludes.

Read a veterinarian's take on the new policy, and how it will affect producers: Veterinarian Addresses Proposed Antibiotic Changes

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