US Senate Tells FDA to Increase Antibiotic Monitoring

US Senate Tells FDA to Increase Antibiotic Monitoring

August 21st, 2012 // 2:05 pm @ jmpickett

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Last April, the FDA issued various guidances that were designed to tighten the use of antibiotics in animals that are used to produce food. As part of its plan, the agency hoped to convince drugmakers to voluntarily curtail their “injudicious” use of antibiotics – specifically, labeling changes were sought so that antibiotics are not used for production purposes. And three drugmakers – Eli Lilly, Pfizer and Merck – subsequently agreed to do so.

In its reports, the FDA recommended that farmers obtain prescriptions to get antibiotics for their livestock and antibiotics should only be given when medically necessary to avoid overuse that can create resistance. “The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective,” FDA commish Margaret Hamburg said at the time (see this).

But earlier this week, a group of 13 US senators has written the agency to say that its initiative falls short and want the documents strengthened. Specifically, they asked the FDA to increase oversight of antibiotics and eliminate any antibiotic use for promoting animal growth (here is the April 13 guidance and the April 13 draft guidance). In their view, the continued use of antibiotics for disease prevention is inadequate.

“There is considerable ambiguity about the actual impact of this guidance,” they write. “If broadly defined, disease prevention could allow the continued use of antibiotics in ways not consistent with the FDA’s vision for ‘judicious use.’ This could include inappropriate and ineffective practices that merely mask underlying production problems such as poor hygiene or animal overcrowding.”

The senators also maintain the agency “lacks a plan for monitoring and evaluating implementation.” And they point out the FDA acknowledged there is no “detailed drug use data” to enable the FDA to estimate total antibiotic usage to gauge phased out production or less growth promotion, notes Regulatory Focus, which first wrote about the August 13 letter to the FDA and notes the agency is considering a rule that would require more reporting of veterinary antimicrobial drug sales and distribution.

“This is of great concern to us, and we urge the agency to design a system with relevant agencies and stakeholders for gathering and analyzing necessary information to assess the effectiveness of the new policies. Should you find any critical gaps in your statutory authority, we would welcome the opportunity to work with you to provide additional authorities and resources,” the senators write (here is the letter).

The letter, by the way, was released by the Pew Campaign on Human Health and Industrial Farming, which supports the FDA initiative but has also called for the agency to strengthen its draft measures and take further steps if industry does not voluntarily limit antibiotic use