FDA Denies Requests to Prohibit Use of Certain Antibiotics in Food Animals

After a coalition of advocacy organizations filed a lawsuit against the Food
and Drug Administration (FDA) seeking an order compelling the agency to
rule on 1999 and 2005 petitions that asked the agency to withdraw approval
of certain antimicrobial drugs in food animal production, the agency finally
acted. Information about the lawsuit appears in Issue 396 of this Update.

According to November 7, 2011, letters addressed to the Center for Science in the Public Interest (CSPI) and Environmental Defense, “the Agency has decided not to institute formal withdrawal proceedings at this time and instead is currently pursuing other alternatives to address the issue of antimicrobial resistance related to the production use of antimicrobials in animal agriculture.”

FDA contends that withdrawal proceedings can be protracted and consume significant agency resources. While the agency notes that it shares the petitioners’ “concern about the use of medically important antimicrobial drugs in food-producing animals for growth promotion and feed efficiency indications,” it is addressing the issue with draft industry guidance establishing the principle that such drugs “should be limited to those uses that are considered necessary for assuring animal health.” Based on stakeholder feedback, “FDA believes that the animal pharmaceutical industry is generally responsive to the prospect of working cooperatively with the Agency to implement” the guideline principles.

CSPI Executive Director Michael Jacobsen expressed disappointment with
FDA’s response, stating, “The industry’s irresponsible use of antibiotics in
livestock increases the prevalence of antibiotic-resistant pathogens, and those
germs can cause infections in humans that are difficult or impossible to treat.
The industry has long failed to cooperate voluntarily, and the FDA should take
binding action. Consumers cannot afford another decade of delay.” See CSPI
Statement, November 9, 2011.