October 19, 2018

Johns Hopkins Experts on FDA Antibiotic Guidance

The experts at Johns Hopkins Center for a Livable Future have released a statement on the FDA’s guidance document for reducing antibiotic use in farm animals. They say that “FDA’s voluntary guidelines on antibiotics fail to protect public health.”

Petri DishGuidance for Industry #213 asks drug companies to voluntarily withdraw approvals to use antibiotics for growth promotion. Unfortunately, factory farms can still use antibiotics at a sub therapeutic level for disease prevention. And FDA guidance does not have the fore of law behind it; this is only a recommendation. And since 80% of antibiotics sold in this country are used in food animals on the farm, not to treat sick people, this is significant.

CDC has stated that just one antibiotic resistant pathogen, methicillin-resistant Staphylococcus aureus (MRSA) causes more than 94,000 resistant infections and kills more than 18,000 people in this country every single year. The cost to the US health system of antibiotic resistant infections is as much as $26 billion per year, in illnesses, medical cost, and other costs.

The issue is that giving health animals low doses of antibiotics is the perfect ground for bacteria to evolve resistance to the drugs. Most antibiotics in farm animals will still be used this way. Zoetis, former Pfizer Animal Health, told the Wall Street Journal that the guidelines “will not have a significant impact on our revenues.”

Johns Hopkins said that FDA has the regulatory authority to withdraw approvals for antibiotics used for growth promotion and disease prevention. Even though a judge ordered the FDA to reconsider its denials of citizen petitions to withdraw these drug approvals, the FDA is appealing the decision.

Dr. Robert Lawrence, director of CLF said, “the widespread misuse of antibiotics in food animal production reduces the effectiveness of drugs we heavily rely on to keep the public and our families safe. An infection that is now considered relatively easy to treat could once again prove fatal should antibiotics continue to be misused in food animal production and exacerbate this growing public health crisis. Dr. Keeve Nachman, a CLF scientist, said, “The agency needs to change how antibiotics are used, but these guidelines will only change how they are labeled.”

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