[Congressional Record Volume 153, Number 26 (Monday, February 12, 2007)]
[Senate]
[Pages S1853-S1854]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. KENNEDY (for himself, Ms. Snowe, Mr. Reed, and Mr. Brown):
  S. 549. A bill 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; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. KENNEDY. Mr. President, it is a privilege to join Senator Snowe 
in introducing ``The Preservation of Antibiotics for Medical Treatment 
Act of 2007.'' I am also pleased that this year we are joined by 
Senator Sherrod Brown, who championed this legislation so ably as a 
member of the House of Representatives.
  Our goal in this important initiative is to take needed action to 
preserve the effectiveness of antibiotics in treating diseases. These 
drugs are truly modern medical miracles. During World War II, the newly 
developed ``wonder drug'' penicillin revolutionized care for our 
soldiers wounded in battle. Since then, such drugs have become 
indispensable in modern medicine, protecting all of us from deadly 
infections. They are even more valuable today, safeguarding the Nation 
from the threat of bioterrorism.
  Unfortunately, in recent 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 over-prescribing such drugs 
in routine medical care. Mounting evidence shows that indiscriminate 
use of such 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 the problem. The problem is the widespread use of antibiotics to 
promote growth and fatten healthy livestock. Such 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--nine 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, a 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--8 
times more than are used in all of human medicine. This indiscriminate 
use clearly reduces their potency.
  Major medical associations have been increasingly concerned, and have 
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 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 the current detrimental practice is feasible and cost-
effective. Last month an economic study by researchers at Johns Hopkins 
University examined data from the poultry producer Perdue. In this 
study of 7 million chickens, the slight benefit from the nontherapeutic 
use of antibiotics was more than offset by the cost of purchasing 
antibiotics.
  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 funds saved on drugs have 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 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 6 years ago said it all: 
``Antimicrobial Use in Animal Feed--Time to Stop.''
  In the last Congress, over 350 organizations representing scientific 
and medical associations, consumer and environmental groups as well as 
animal rights and religious groups endorsed this legislation and called 
for an end to the reckless and irresponsible use of these critically 
important medicines.
  The Nation is clearly at risk of an epidemic outbreak of food 
poisoning caused by drug-resistant bacteria or other germs. In recent 
years, many nations, including the United States, have been plagued by 
outbreaks of food-borne illnesses. Imagine the consequences of an 
outbreak caused by a strain of bacteria immune to any drugs we have. It 
is time to put public safety first and stop this promiscuous use of 
drugs essential for protecting human health.
  The bill we are introducing will phase out the non-therapeutic use in 
livestock of medically important antibiotics, unless manufacturers can 
demonstrate that such use is no danger to public health. The Act 
applies this same strict standard to applications for approval of new 
animal antibiotics. Such use is not restricted if the animals are sick, 
or if they are pets or are animals not used for food. In addition, FDA 
is also given authority to restrict the use of important drugs to treat 
such animals, if risk to humans is in question.
  According to the National Academy of Sciences, eliminating the use of 
antibiotics as feed additives in agriculture will cost each American 
consumer not more than five to ten dollars a year. The legislation 
recognizes, however, that 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 special preference for 
family farms.
  Antibiotics are one of the great miracles of modem medicine. Yet 
today, we are destroying them faster than the pharmaceutical industry 
can replace them with new discoveries. If doctors lose these vital 
medications, the most vulnerable Americans will suffer the most--
children, the elderly, persons with HIV/AIDS, and others who are most 
in danger of drug resistant infections. I urge my colleagues to support 
this clearly needed legislation to protect the health of all Americans 
from the reckless and unjustified use of antibiotics.
  Ms. SNOWE. Mr. President, today we face concerns about infectious 
disease which few could have anticipated. Over a half century ago, 
following the development of modem antibiotics, Nobel Laureate Sir 
McFarland Burnet

[[Page S1854]]

summed up what many experts believed when he 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 we face grave concern about pandemic 
influenza, and in fact every day many of the most serious 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 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 critical to address preserving lifesaving antibiotic 
drugs for use in treating disease.
  Today over nine out of ten Americans understand that resistance to 
antibiotics is a problem. Most Americans have learned that that colds 
and flu are caused by viruses, and recognize that treating a cold with 
an antibiotic is inappropriate. Our health care providers are more 
careful to discriminate when to use antibiotics, because they 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, both to address natural and man-made threats. It is so 
counterproductive to develop antimicrobial drugs and see their misuse 
render them ineffective.
  Yet 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.
  Two years ago 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 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. We must do more 
to address inappropriate antibiotic use in medicine, the use of these 
drugs in our environment cannot be ignored.
  This is why I have joined with Senator Kennedy in again introducing 
the ``Preservation of Antibiotics for Medical Treatment Act''. This 
bill phases out the nontherapeutic uses of critical medically important 
antibiotics in livestock and poultry production, unless their 
manufacturers can show that they pose no danger to public health.
  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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