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Senators Call on FDA to Strengthen Antibiotic Monitoring

Posted 16 August 2012 | By Alexander Gaffney, RAC 

A group of 13 senators is calling on the US Food and Drug Administration (FDA) to tighten the requirements of recently-released antibiotics guidance documents.

The guidance documents, released in April 2012, called for manufacturers to voluntarily limit the "injudicious" use of their antibiotic products in food-producing animals. At the time, FDA said it had received voluntary assurances from Pfizer, Eli Lilly and Merck that they would implement the changes.

Definition of 'Disease Prevention' at Issue

In their letter, the senators-a bipartisan group including Democrats, Independents and a Republican-said they wished to "commend" FDA on its initiative, but said the agency should "further strengthen the document."

The senators highlighted two aspects of the guidance documents as beneficial: the elimination of the use of antibiotics to promote the physical growth of animals and the increased oversight of antibiotics.

But the senators also said FDA did not go far enough in limiting the use of antibiotics for "disease prevention," and said significant ambiguity around the term could allow for the use of antibiotics against the spirit of the guidance.

"This could include inappropriate and ineffective practices that merely mask underlying production problems such as poor hygiene or animal overcrowding," they wrote.

Monitoring and Evaluation-Is FDA Ahead of Criticism?

The senators also said they were disappointed the agency's guidance did not contain provisions to allow for monitoring and evaluation-something they said was of "great concern" to the group.

They may be heartened regarding this last point, however. In May 2012, FDA updated its National Antimicrobial Resistance Monitoring System to include improved sampling strategies, optimize its use of data and launch collaborative projects with other regulatory bodies and agencies. Even more importantly, FDA announced an advanced notice of proposed rulemaking on 27 July indicating its intent to require sales reporting and distribution data for antimicrobial animal drugs, which it said would allow it to track antimicrobial resistance in animals.

This proposed regulation might satisfy the senators' request for a system, "That would enable us to estimate quantitatively the reduction in the total volume of use that would be expected with phasing out the production or growth promotion uses of medically important drugs."


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