Thirteen United States Senators wrote to FDA Commissioner Margaret Hamburg, asking the agency to strengthen Guidance for Industry 209, which proposes voluntary reductions for the use of antibiotics in food animals. The letter urges the FDA to “revise veterinary antibiotic labels to eliminate the use of antibiotics for ‘growth promotion’, and to increase and improve veterinary oversight of antibiotics used in food animal production.”
The letter states that the Guidance documents allow for the use of antibiotics for “disease prevention”, but there is ambiguity about what that phrase actually means. “Disease prevention” could allow antibiotic use inconsistent with “judicious use” that could hide underlying issues such as animal overcrowding and poor hygiene.
The FDA’s Draft Guidance 213 does not propose a plan for monitoring and evaluating Guidance for Industry 209. In fact, according to the FDA, they do “not have detailed drug use data that would enable us to estimate quantitatively the reduction in the total volume of use that would be expected with phasing out the production or growth promotion uses of medically important drugs.” In other words, the government has no way to see if their voluntary guidelines would be effective. The senators add that they would work with the FDA to “provide additional authorities and resources” if the agency needs more statutory authority.
The letter ends by stating that the FDA itself acknowledges that overuse of antibiotics in the food animal industry is a key factor in the development of antibiotic resistance in human beings. This fact has been confirmed by the World Health Organization, Johns Hopkins, Harvard School of Medicine, and the Pew Campaign on Human Health. The letter is signed by Senators Dianne Feinstein (D-CA), Herb Kohl (D-WI), Susan Collins (R-ME), Frank Lautenberg (D-NJ), Bernie Sanders (I-VT), John Kerry (D-MA), Patrick Leahy (D-VT), Kirsten Gillibrand (D-NY), Barbara Boxer (D-A), Joe Lieberman (I-CT), Jack Reed (D-RI), Maria Cantwell (D-WA), and Ron Wyden (D-OR).