To Fight Superbugs, FDA Seeks Detailed Data on Drug Use in Animals

Drugmakers are being asked to spell out their sales according to their use in cattle, swine or poultry as part of a new proposed rule

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By Reuters Staff

(Reuters) - The U.S Food and Drug Administration said it is asking drugmakers for data on antimicrobials sold for use in each food animal, such as cows and chickens, as part of efforts to combat antibiotic-resistant bacteria.

Currently, drugmakers are required to submit collective data on antimicrobials sold for use in food animals, rather than spell out sales according to their use in just cattle or swine or chicken or turkey.

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Detailed information on the use of medically important antimicrobials - a group of drugs that includes antibiotics, antifungals and antivirals - will help it discern patterns of resistance and identify disease trends, the FDA said in a statement on Tuesday.

The World Health Organization has deemed the rising tide of drug-resistant bacteria, or so-called superbugs, as the "single greatest challenge in infectious diseases."

In the United States, superbugs cause 2 million serious infections and 23,000 deaths each year, according to the U.S. Centers for Disease Control and Prevention (CDC) estimates, which some health experts consider conservative.

The White House in March instructed the CDC to slash rates of infections from antibiotic-resistant bacteria by 2020.

In an April report on antibiotics that are medically important to humans, the FDA said sales of antibiotics approved for use in livestock jumped 20% between 2009 and 2013.

While the agency has released voluntary guidelines to phase out the use of antibiotics as a growth enhancer in livestock, agribusinesses defend the practice, saying these drugs are needed to help keep food animals healthy and increase meat production.

The FDA said on Tuesday that while species-specific information will give a fuller picture, it needed more details, such as on-farm use practices, to adequately understand the links between usage patterns and trends in resistance.

The agency said a final rule will be issued following a 90-day comment period.

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