FDA Reverses Decision to Ban Certain Antibiotic Use in Food Animals

January 21, 2009 -- Late last year, the U.S. Food and Drug Administration revoked the order prohibiting the extra label use of cephalosporins in food-producing animals, reversing a decision made this summer to ban the practice. The agency's initial decision to restrict some uses of this class of antibiotics stemmed from fears that excessive use in animals such as cows, swine, and chickens could promote drug resistance in strains of bacteria that also infect people.

Citing the importance of cephalosporin drugs for treating disease in humans, on July 3 the FDA announced a planned crackdown on “extra label” use in animals -- the practice of using the drug for a purpose outside the scope of its approved label. However, agriculture groups and makers of veterinary drugs claim that antibiotics are needed, while others have claimed that the data on the human impact used to support the ban were flawed. On Nov. 25 the FDA revoked its decision, saying it had received a number of comments and needed more time to review them; the agency added that it could still impose restrictions later.

As far back as the 1980s, the National Research Council and Institute of Medicine warned of the dangers of overuse of antibiotics in food animals. In the 1998 report The Use of Drugs in Food Animals: Benefits and Risks, they noted that antibiotic resistance in humans and animals had risen sharply during the last several decades. The report recommended that the federal government form an oversight panel to ensure the appropriate use of antibiotics, and establish a national database to monitor microbe-related illnesses and trends in antibiotic resistance that may result from drug use in food animals.

In 2003 the Institute of Medicine report Microbial Threats to Health: Emergence, Detection, and Response urged FDA to ban the use of certain anti-microbials in animals if those same drugs could be used to treat illness in humans. The recommendation's goal is to reduce the chances of developing drug-resistant organisms in animals that could eventually cause hard-to-treat diseases in people.

• USDA Agricultural Research Service