Letter

Former FDA Heads Urge White House to Fight Superbugs, Curb Antibiotic Overuse

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Two former FDA commissioners – David Kessler (1990-1997) and Donald Kennedy (1977-1979) – wrote to OMB Director Sylvia Matthews Burwell urging her to take action on antibiotics in agricultural feed.

"We are convinced that feeding low doses of antibiotics to livestock and poultry is a recipe for disaster," they wrote. "This administration should finalize Guidance 213 and end antibiotic use for growth promotion and unnecessary disease prevention, tell the public how data will be collected to ensure that its voluntary strategy is working and then, if antibiotic misuse continues unabated, apply the full force of regulation. It should also require veterinarian oversight of antibiotic use in feed."

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November 12, 2013

The Honorable Sylvia Matthews Burwell
Director, Office of Management and Budget
Executive Office of the President
725 17th Street, NW
Washington, DC 20503

Dear Director Burwell:

We are writing to urge you take swift action to curb unnecessary uses of medically-important antibiotics in food animal production. Specifically, we support prompt finalization of a strong Food and Drug Administration Guidance #213 ending antibiotic use for growth promotion and unnecessary disease prevention, as well as publication of rule proposals to expand veterinary oversight of in-feed antibiotic use and to collect data on antibiotic use in animal agriculture. We have more than enough scientific evidence to justify curbing the rampant use of antibiotics for livestock, and, as former FDA Commissioners, we appreciate that the Obama administration is poised to take significant action on this elusive public health challenge, even up against tremendous industry pressures.

We are convinced that feeding low doses of antibiotics to livestock and poultry is a recipe for disaster. The FDA first raised concerns about this practice in the 1970s when it proposed a rule that was thwarted by Congress. Since then, the antibiotic resistance crisis has only grown.

We recognize that we are facing what the Centers for Disease Control and Prevention and World Health Organization name a looming "catastrophe" of failing antibiotic treatments caused by overuse and misuse of antibiotics in both human medicine and agriculture. FDA reports now show that 80 percent of all antibiotics in the United States are being sold for use in farming--an increase over previous years. All segments of society should be part of the solution, especially that which uses the vast majority of the antibiotics.

The FDA issued a draft version of its policy in April 2012 and received public comments, as required, but the comment period closed over a year ago. Drugmakers have been left awaiting further instruction. The new guidelines cannot come soon enough. The FDA annually examines bacteria on retail meat and poultry, and each year the bugs show more resistance to antibiotics.

Moreover, several new studies using genetic analysis demonstrate with great precision the evolution and transmission of resistant pathogens not traditionally linked to food. Methicillinresistant Staphylococcus aureus is a troublesome new source of livestock-associated infections, and the E. coli that cause drug-resistant urinary tract infections can also be transmitted to people via food.

Action by the Obama administration would be an initial-and long-awaited-step to encourage livestock producers to stop relying on massive overuse of antibiotics to compensate for overcrowding, poor hygiene, and lax animal health management. This administration should finalize Guidance 213 and end antibiotic use for growth promotion and unnecessary disease prevention, tell the public how data will be collected to ensure that its voluntary strategy is working and then, if antibiotic misuse continues unabated, apply the full force of regulation. It should also require veterinarian oversight of antibiotic use in feed.

It has been 36 years since the FDA moved to restrict injudicious antibiotic practices that threatened the public's health. It should not wait any longer to finish the job. You have our support to take the next step.

Sincerely,

Donald Kennedy, Ph.D.
Former Comrnisstoner
U.S. Food and Drug Administration

David Kessler, M.D.
Former Commissioner
U.S. Food and Drug Administration

Cc: Secretary Kathleen Sebelius, U.S. Department of Health and Human Services
Commissioner Margaret A. Hamburg, M.D., Food and Drug Administration