[Congressional Record (Bound Edition), Volume 151 (2005), Part 5]
[Senate]
[Pages 6004-6005]
[From the U.S. Government Publishing Office, www.gpo.gov]




              ANTIBIOTICS FOR HUMAN TREATMENT ACT OF 2005

  Mr. KENNEDY. Mr. President, it is a privilege to join my 
distinguished colleagues, in proposing The Preservation of Antibiotics 
for Human Treatment Act of 2005. Our goal in this important initiative 
is to take needed action to preserve the effectiveness of antibiotics 
in treating diseases.
  These drugs are truly a modem medical miracle. During World War II, 
the newly developed ``wonder drug'' penicillin revolutionized the care 
for our soldiers wounded in battle. Since then, they have become 
indispensable in modem medicine, protecting all of us from deadly 
infections. They are even more valuable today, safeguarding the nation 
from the threat of bioterrorism. Unfortunately, over the past years, we 
have done too little to prevent the emergence of antibiotic-resistant 
strains of bacteria and other germs, and many of our most powerful 
drugs are no longer effective.
  Partly, the resistance is the result of the overprescribing of such 
drugs in routine medical care. But, mounting evidence also shows at the 
indiscriminate use of critical drugs in animal feed is also a major 
factor in the development of antibiotic resistant germs.
  Obviously, if animals are sick, whether as pets or livestock, they 
should be treated with the best veterinary medications available. That 
is not a problem. The problem is the widespread practice of using 
antibiotics to promote growth and fatten healthy livestock. This 
nontherapeutic use clearly undermines the effectiveness of these 
important drugs because it leads to greater development of antibiotic-
resistant bacteria that can make infections in humans difficult or 
impossible to treat.
  In 1998--7 years ago--a report prepared at the request of the 
Department of Agriculture and the Food and Drug Administration, by the 
National Academy of Sciences, concluded ``there is a link between the 
use of antibiotics in food animals, the development of bacterial 
resistance to these drugs, and human disease.'' The World Health 
Organization has specifically recommended that antibiotics used to 
treat humans should not be used to promote animal growth, although they 
could still be used to treat sick animals.
  In 2001, Federal interagency task force on antibiotic resistance 
concluded that ``drug-resistant pathogens are a growing menace to all 
people, regardless of age, gender, or socio-economic background. If we 
do not act to address the problem . . . [d]rug choices for the 
treatment of common infections will become increasingly limited and 
expensive-and, in some cases, nonexistent.''
  The Union of Concerned Scientists estimates that 70 percent of all 
U.S. antibiotics are used nontherapeutically in animal agriculture--
eight times more than in are used in all of human medicine. This 
indiscriminate use clearly reduces their potency.
  Major medical associations have been increasingly concerned and taken 
strong stands against antibiotic use in animal agriculture. In June 
2001, the American Medical Association adopted a resolution opposing 
nontherapeutic use of antibiotics in animals. Other professional 
medical organizations that have taken a similar stands include the 
American College of Preventive Medicine, the American Public Health 
Association, and the Council of State and Territorial Epidemiologists. 
The legislation we are offering has been strongly endorsed by the 
American Public Health Association and numerous other groups and 
independent experts in the field.
  Ending this detrimental practice is feasible and cost-effective. In 
fact, most of the developed countries in the world, except for the 
United States and Canada, already restrict the use of antibiotics to 
promote growth in raising livestock. In 1999, the European Union banned 
such use and money saved on drugs has been invested in improving 
hygiene and animal husbandry practices. Researchers in Denmark found a 
dramatic decline in the number of drug-resistant organisms in animals--
and no significant increase in animal diseases or in consumer prices.
  These results have encouraged clinicians and researchers to call for 
a similar ban in the United States. The title of an editorial in the 
New England Journal of Medicine 4 years ago said it all: 
``Antimicrobial Use in Animal Feed--Time to Stop.''
  On Thursday, the American Academy of Pediatrics, the American Public 
Health Association, Environmental Defense, the Food Animal Concerns 
Trust, and the Union of Concerned Scientists joined together in filing 
a formal petition with FDA calling for the withdrawal of certain 
classes of drugs from animal feed.
  Earlier last week, Acting FDA Commissioner Lester Crawford emphasized 
his own concern that the use of such drugs in food-producing animals 
has an adverse health impact on humans. He stated that the FDA agrees 
with the GAO recommendation to review approved animal drugs that are 
critical to human health, and described FDA's progress in doing so. He 
stated, however, that the review process is extremely slow and labor 
intensive, and that even when safety issues are identified, the FDA can 
do little more than hope that the animal pharmaceutical companies will 
cooperate in addressing the issue.

[[Page 6005]]

  There is no question that the Nation stands at risk of an epidemic 
outbreak of food poisoning caused by drug-resistant bacteria or other 
germs. It is time to put public safety first and stop the abuse of 
drugs critical to human health.
  The bill we propose will phase out the nontherapeutic use in 
livestock of medically important antibiotics, unless manufacturers can 
show such use is no danger to public health. The act requires applying 
this same strict standard to applications for approval of new animal 
antibiotics. Treatment is not restricted if the animals are sick or are 
pets or other animals not used for food. In addition, FDA is given the 
authority to restrict the use of important drugs in animals, if the 
risk to humans is in question.
  According to the National Academy of Sciences, eliminating the use of 
antibiotics as feed additives in agriculture would cost each American 
consumer not more than five to ten dollars a year. The legislation 
recognizes, however, economic costs to farmers in making the transition 
to antibiotic-free practices may be substantial. In such cases, the Act 
provides for federal payments to defray the cost of shifting to 
antibiotic-free practices, with preference for family farms.
  Antibiotics are among the greatest miracles of modern medicine, yet 
we are destroying them faster than the pharmaceutical industry can 
create replacements. If doctors lose these critical remedies, the most 
vulnerable among us will suffer the most--children, the elderly, 
persons with HIV/AIDS, who are most in danger of resistant infections. 
I urge my colleagues to support this clearly needed legislation to 
protect the health of all Americans from this reckless and unjustified 
use of antibiotics.
  Ms. SNOWE. Mr. President, today we are facing a public health crisis 
which most of us certainly did not anticipate. Nearly a half century 
ago, following the development of modern antibiotics, Nobel Laureate 
Sir McFarland Burnet stated, ``One can think of the middle of the 
twentieth century as the end of one of the most important social 
revolutions in history, the virtual elimination of infectious diseases 
as a significant factor in social life.''
  How things have changed. Today some of our most deadly health threats 
come from infectious diseases. When we consider the greatest killers--
HIV, tuberculosis, malaria--it is clear that infectious diseases have 
not abated. At the same time we have seen an alarming trend--
increasingly physicians are stymied as existing antibiotics are 
becoming less effective in treating infections. We know that resistance 
to drugs can be developed, and that the more we expose bacteria to 
antibiotics, the more resistance we will see. So it is crucial that we 
preserve antibiotics for use in treating disease.
  Most Americans appreciate this fact, and now understand that colds 
and flu are caused by viruses. So we know that treating a cold with an 
antibiotic is inappropriate, and we understand that such use of 
antibiotics is unwise. Over 9 out of 10 Americans now know that 
resistance to antibiotics is growing. Our health care providers are 
getting the message too. Physicians know that when a patient who has 
been inappropriately prescribed an antibiotic actually develops a 
bacterial infection, it is more likely to be resistant to treatment.
  When we overuse antibiotics, we risk eliminating the very cures which 
scientists fought so hard to develop. The threat of bioterrorism 
amplifies the danger. I have supported increased NIH research funding, 
as well as Bioshield legislation, in order to promote development of 
essential drugs. Yet as we work hard to develop lifesaving medications, 
their misuse will render them ineffective.
  Every day in America antibiotics continue to be used in huge 
quantities for no treatment purpose whatsoever. I am speaking of the 
non-therapeutic use of antibiotics in agriculture. Simply put, the 
practice of feeding antibiotics to healthy animals jeopardizes the 
effectiveness of these medicines in treating ill people and animals.
  Recognizing the public health threat caused by antibiotic resistance, 
Congress in 2000 amended the Public Health Threats and Emergencies Act 
to curb antibiotic overuse in human medicine. Yet today it is estimated 
that 70 percent of the antimicrobials used in the United States are fed 
to farm animals for non-therapeutic purposes including growth 
promotion, poor management practices and crowded, unsanitary 
conditions.
  In March 2003, the National Academies of Sciences stated that a 
decrease in antimicrobial use in human medicine alone will not solve 
the problem of drug resistance. Substantial efforts must be made to 
decrease inappropriate overuse of antibiotics in animals and 
agriculture.
  Last week five major medical and environmental groups--the American 
Academy of Pediatrics, the American Public Health Association, 
Environmental Defense, the Food Animal Concerns Trust and the Union of 
Concerned Scientists--jointly filed a formal regulatory petition with 
the U.S. Food and Drug Administration urging the agency to withdraw 
approvals for seven classes of antibiotics which are used as 
agricultural feed additives. They pointed out what we have known for 
years--that antibiotics which are crucial to treating human disease 
should never be used except for their intended purpose--to treat 
disease.
  In a study just reported in the New England Journal of Medicine, 
researchers at the Centers for Disease Control and Prevention found 17 
percent of drug-resistant staph infections had no apparent links to 
health-care settings. Nearly one in five of these resistant infections 
arose in the community--not in the health care setting. While must do 
more to address inappropriate antibiotic use in medicine, and use in 
our environment cannot be ignored.
  This is why I have joined with Senator Kennedy to again introduce the 
``Preservation of Antibiotics for Medical Treatment Act''. This bill 
phases out the non-therapeutic uses of critical medically important 
antibiotics in livestock and poultry production, unless their 
manufacturers can show that they pose no danger to public health. I am 
pleased that we have been joined in this effort by Senator Collins, 
Senator Landrieu, and Senator Reed in introducing this measure.
  Our legislation requires the Food and Drug Administration to withdraw 
the approval for nontherapeutic agricultural use of antibiotics in 
food-producing animals if the antibiotic is used for treating human 
disease, unless the application is proven harmless within two years. 
The same tough standard of safety will apply to new applications for 
approval of animal antibiotics.
  This legislation places no unreasonable burden on producers. It does 
not restrict the use of antibiotics to treat sick animals, or for that 
matter to treat pets and other animals not used for food. The act 
authorizes Federal payments to small family farms to defray their 
costs, and it also establishes research and demonstration programs that 
reduce the use of antibiotics in raising food-producing animals. The 
act also requires data collection from manufacturers so that the types 
and amounts of antibiotics used in animals can be monitored.
  As we are constantly reminded, the discovery and development of a new 
drug can require great time and expense. It is simply common sense that 
we preserve the use of the drugs which we already have, and use them 
appropriately. I call on my colleagues to support us in this effort.

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