December 13, 2018

Senators Ask FDA for More Info About Animal Antibiotic Use

Senators Elizabeth Warren (D-MA), Dianne Feinstein (D-CA), and Kirsten Gillibrand (D-NY) have written a letter to FDA Commissioner Margaret Hamburg, asking her for more information about the public health threat of antibiotic resistant bacteria. They are concerned that the FDA’s policies on sub therapeutic use of antibiotics in farm animals do not go far enough to address this growing problem. A recently approved Veterinary Feed Directives rule would require farmers to obtain a “prescription-like document” to acquire “nearly all” antibiotics.

CongressLast week the U.S. Second Circuit Court of Appeals in New York ruled that the FDA does not need to hold hearings on antibiotic use in farm animals to force the industry to prove this practice is safe. Food safety advocates were dismayed by this ruling, since antibiotic use in farm animals has been linked to the development of antibiotic-resistant bacteria.

The letter states that new CDC data estimates antibiotic-resistant bacteria from contaminated food cause roughly 430,000 illnesses in the United States every year. Research also shows that antibiotic resistant bacteria develop when the drugs are used continuously at low doses. Antibiotics are used in this manner to promote growth and to prevent diseases in animals that live in filthy conditions.

Guidance #209 and #213 issued by the FDA do effectively end the use of antibiotics for growth promotion, but still permit the use for disease prevention. Some antibiotics can be used “in times of stress,” which is very vague. And many of these regimens have the same dosages as growth-promotion schedules.

The letter asks how the FDA will determine “whether the non-judicious use of antibiotics in food animal production materially declines as a consequences of those guidance documents.” It also asks what steps the FDA will take if no change in overall antibiotic use is observed. The senators want to know what actions the FDA will take to make sure the labeling indications don’t pose the same risks as uses that are being phased out, and the FDA’s plan for facilities inspections. Finally, they want to know how the FDA will collect and compile data from the Veterinary Feed Directives rule to track how these drugs are being used.

 

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