March 01, 2011

 

 Drug resistance monitoring to be adapted by 2015

 
posted February 18, 2011
 
 
 
Antimicrobial resistance surveillance could expand in areas involving humans and animals as authorities with the federal monitoring system work to improve the program over the next several years.
 

The Food and Drug Administration published in late January a draft 2011-2015 strategic plan for the National Antimicrobial Resistance Monitoring System. The FDA is accepting comments on the plan through March 25.

NARMS is a collaborative program developed by the FDA, the Centers for Disease Control and Prevention, and the Department of Agriculture.

The plan published in January has four broad goals that involve creating a shared database for the agencies that contribute to NARMS, providing sampling that is more representative and applicable for trend analysis, increasing collaboration on laboratory-based and epidemiologic research, and supporting international food safety and antimicrobial resistance surveillance programs.

The draft plan indicates that, in reaching the sampling-related goal, the FDA plans to establish by 2014 "systematic, representative monitoring" of antimicrobial-resistant commensal bacteria isolated from humans. The document indicates commensal bacteria can serve as resistance gene reservoirs and transfer such genes to pathogens.

The document lists target completion years for about half the projects proposed, to help reach the overall goals. The database launch is planned for 2012; by 2013, more data should be available to stakeholders and surveillance data should be published closer to the time of collection.

The proposal also indicates NARMS would modify collection of samples from animals to overcome current biases created by relying on the USDA Food Safety and Inspection Service's Hazard Analysis and Critical Control Points compliance sampling, which collects post-slaughter samples on the basis of risk. NARMS would also implement surveillance of resistant bacteria isolated from animal feed.

The research goal includes studying the prevalence of drug-resistant bacteria in food products and their risk to consumers as well as conducting epidemiologic studies focused on the public health impact of antimicrobial-resistant foodborne infections.

The goals involving international activity include supporting World Health Organization programs, increasing capacity for foodborne pathogen and antimicrobial resistance surveillance, and sharing data.

Paula J. Fedorka-Cray, PhD, a research leader at the USDA Agricultural Research Service and leader of the animal surveillance arm of NARMS, said the proposed changes should strengthen surveillance and improve the quality and quantity of data NARMS produces. Although she expects the changes will provide better information on antimicrobial resistance, the USDA will maintain a similar role in surveillance of antimicrobial resistance in livestock.

"Essentially, there are no major changes proposed," Dr. Fedorka-Cray said. "There are only enhancements."

To view the document or submit comments, go to www.regulations.gov and search for FDA-2010-N-0620. Comments can also be mailed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.