Food and Drug Administration (FDA)
Final rule on New Animal Drugs; Cephalosporin drugs; Extralabel Animal Drug Use;
Order of Prohibition
Docket Number FDA-2008-N-0326
March 6, 2012
In July 2008, the Food and Drug Administration’ (FDA) proposed a final rule banning all extralabel uses of cephalosporin antimicrobial drugs in food-producing animals. In response to comments, primarily by industry, FDA withdrew the rule in late November, 2008.2 Now FDA proposes a ban on only some uses of cephalosporins in food-producing animals.
Consumers Union3 (CU) welcomes the opportunity to comment on this final rule. CU supports the ban on certain extralabel uses of cephalosporin antimicrobial drugs in certain food producing animals, and commends the FDA for taking this important needed step in protecting public health from the threat of antimicrobial resistance. Both the FDA4 and the World Health Organization’ consider cephalosporins to be critically
important in human medicine. For the reasons explained below, however, we feel that this rule is only a first step, and that FDA should take further, stronger steps to significantly reduce the growing problem ofthe spread of antimicrobial resistance among bacteria.
For the full comments, click here.