U.S. Senators' Letter to FDA Commissioner Margaret Hamburg

Dear Commissioner Hamburg:

We write to commend the FDA for releasing Guidance for Industry 209-which proposes voluntary reductions in the use of antibiotics in food animal production-and to urge you to further strengthen the document.

FDA's Guidance 209 and its accompanying blueprint for implementation, Draft Guidance 213, make two important recommendations which we support in principle:

• Revise veterinary antibiotic labels to eliminate the use of antibiotics for "growth promotion"; and,
• Increase and improve veterinary oversight of antibiotics used in food animal production.

However, because the Guidance documents allow for the continued use of antibiotics for "disease prevention," there is considerable ambiguity about the actual impact of this guidance. If broadly defined, "disease prevention" could allow the continued use of antibiotics in ways not consistent with the FDA's vision for "judicious use." This could include inappropriate and ineffective practices that merely mask underlying production problems such as poor hygiene or animal overcrowding.

In addition, Draft Guidance 213 lacks a plan for monitoring and evaluating implementation of this important initiative. By the FDA's own admission, the "FDA does 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." This is of great concern to us, and we urge the agency to design a system with relevant agencies and stakeholders for gathering and analyzing necessary information to assess the effectiveness of the new policies. Should you find any critical gaps in your statutory authority, we would welcome the opportunity to work with you to provide additional authorities and resources.

Thank you again for beginning the process of addressing the issue of antibiotic resistance. As the FDA has previously stated, a wide body of evidence confirms that the overuse of antibiotics in the food animal industry is a key factor in the development of antibiotic resistance in humans. We look forward to working with you on this important issue and hope that you will give serious consideration to our request for a stronger, more effective guidance document.

Sincerely,

Sen. Dianne Feinstein
Sen. Frank R. Lautenberg
Sen. Herbert H. Kohl
Sen. Bernard Sanders
Sen. Susan M. Collins
Sen. John F. Kerry
Sen. Patrick J. Leahy
Sen. Kirsten Gillibrand
Sen. Barbara Boxer
Sen. Joseph I Lieberman
Sen. John F. Reed
Sen. Maria E. Cantwell
Sen. Ronald L. Wyden