Federal Issue Brief

 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011

 

Special Interest: AVMA, Coalition Letter to Congress 10/11/2011 (October 11, 2011)

 

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View bill summary and status: Senate / House (PDF)

Summary:

To amend the Federal Food, Drug, and Cosmetic Act to preserve the effectiveness of medically important antibiotics used in the treatment of human and animal diseases.

AVMA Position:

The AVMA opposes this legislation because it would increase animal disease and death – an unfortunate and unintended consequence – without assurance of improving human health. The legislation proposes to eliminate "non-therapeutic" uses of antimicrobials which would disallow disease prevention and potentially control uses. This broad based ban is contrary to the practice of veterinary medicine and is not risk-based. AVMA urges Congress make decisions based upon science when considering legislation concerning the use of antibiotics in animal agriculture.

Purpose:

  • PAMTA seeks to eliminate the "non-therapeutic" use of antibiotic drugs considered important for human health.
  • The intent of the legislation is to decrease the development of antibiotic-resistant bacteria in humans.
  • PAMTA purports to preserve the effectiveness of medically important antibiotics used in the treatment of human and animal diseases by withdrawing antibiotics for 'non-therapeutic' purposes in food-producing animals unless they can be proven to pose no harm to human health.
  • PAMTA defines critical antimicrobial animal drugs as those intended for use in food-producing animals and are composed wholly or partly of any kind of penicillin, tetracycline, macrolide, lincosamide, streptogramin, aminoglycoside, or sulfonamide, or any other drug or derivative of a drug that is used in humans or intended for use in humans to treat or prevent disease or infection caused by microorganisms.
  • PAMTA defines 'non-therapeutic use', with respect to a critical antimicrobial animal drug, as use of a drug as a feed or water additive for an animal in the absence of any clinical sign of disease in the animal for growth promotion, feed efficiency, weight gain, routine disease prevention, or other routine purpose.

Background:

  • For 40+ years antibiotics have been used to protect our food supply and improve animal health and welfare.
  • FDA has four approved uses of antibiotics: treatment, prevention, control, and growth promotion/feed efficiency.
  • Antibiotics can be administered to animals via injection or orally, through food or water, that can be essential to provide efficient and effective treatment for groups of animals.
  • Denmark, with a pork industry roughly equivalent to the size of the pork herd in Iowa, instituted a ban on the use of antibiotics as growth promoters (AGPs) in 2000 which has not shown any clear declines in antibiotic resistance patterns in humans. The ban has, however, resulted in increased death and disease among animals, greater amounts of antibiotics used to treat and prevent disease, and little evidence to suggest that antibiotic resistance in humans has declined.
  • The Netherlands has also instituted a ban on AGPs beginning in 1999 with similar consequences including increased therapeutic use that has doubled in the past decade. Unfortunately, the ban has not resulted in the intended benefits such as a decline in total use, or more importantly, an improvement in human health.

Existing Layers of Safety Protection

  • The U.S. currently has several layers of protection in place to ensure antibiotics used to keep animals healthy do not harm public health.
    • FDA Approval: The process for the evaluation of food animal antimicrobials (commonly called antibiotics) is at least as stringent, and often more so, than the approval process for human antibiotics. Each food animal antibiotic undergoes a rigorous assessment for human, environmental, and animal safety as a part of the evaluation review by the Food and Drug Administration (FDA). Many of the newer antibiotics have also undergone an extensive review for microbial safety to assess potential human health risks as a result of resistant organisms.
    • Post-Approval Monitoring: Post approval risk assessments on antibiotics have demonstrated a very low risk to human health when antibiotics are used in food animals.
    • Judicious Therapeutic Use Guidelines: AVMA, with support and input from the CDC, Infectious Diseases Society of America, the FDA, and the USDA, developed these guidelines in collaboration with our species specific allied veterinary organizations to safeguard public health by providing specific recommendations for responsible and prudent therapeutic use of antimicrobials.
    • Monitoring and Surveillance Systems: Several public and private surveillance systems have been established to monitor for the emergence of antibiotic resistance:
      • The National Antimicrobial Resistance Monitoring System (NARMS) is a multi-agency program which includes monitoring for resistant bacteria in retail meats by the FDA, monitoring for resistant food-borne pathogens in humans by the CDC, and monitoring for resistant bacteria in animals on farms and animal products in slaughter and processing facilities by the USDA.
      • The Collaboration on Animal Health and Food Safety Epidemiology (CAHFSE) is a program conducted by USDA that collects information on disease status, associated antibiotic use, and resistance of bacteria in farm animals.
      • The SENTRY Antimicrobial Surveillance Program is the most comprehensive human antibiotic resistance surveillance program in the world.

Current Status:

H.R.965 was introduced on 3/09/11 by Rep. Louise Slaughter (D-NY-28). It was referred to the Committee on Energy and Commerce and the Rules Committee. S. 1211 was introduced on 6/15/11 by Sen. Dianne Feinstein (CA) and referred to the Senate Committee on Health, Education, Labor, and Pensions.

AVMA Contact:

Dr. Ashley S. Morgan, Assistant Director Governmental Relations Division, 202-289-3210, or visit www.avma.org/grd.