[Congressional Record Volume 161, Number 35 (Monday, March 2, 2015)]
[Senate]
[Pages S1218-S1219]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. FEINSTEIN (for herself, Ms. Collins, Mrs. Gillibrand, and 
        Ms. Warren):
  S. 621. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
ensure the safety and effectiveness of medically important 
antimicrobials approved for use in the prevention and control of animal 
diseases, in order to minimize the development of antibiotic-resistant 
bacteria; to the Committee on Health, Education, Labor, and Pensions.
  Mrs. FEINSTEIN. Mr. President, I rise today to reintroduce the 
Prevention of Antibiotic Resistance Act, along with my colleague 
Senator Susan Collins. This bill will help to prevent the rise of 
antibiotic resistant pathogens by ensuring that antibiotics are used 
prudently and judiciously in the agriculture industry.
  Antibiotic resistance is a growing public health threat. The Centers 
for Disease Control and Prevention, CDC, estimate that antibiotic-
resistant bacteria cause at least 23,000 deaths and 2 million 
infections each year in the United States. The CDC also estimates that 
antibiotic resistance costs the United States $20 billion in excess 
health costs each year. These statistics will only worsen if we do not 
take meaningful steps to reduce inappropriate and unnecessary 
antibiotic use.
  The agriculture industry has long used antibiotics to increase and 
maintain animal weight gain and feed efficiency. The industry has also 
relied on administering antibiotics to stave off infections associated 
with poor biosecurity or sanitation in barns and feedlots. However, 
based on what we know now about antibiotic resistance, these practices 
no longer make sense.
  I am particularly concerned about the rise of antibiotic resistance 
in foodborne pathogens. Foodborne illness is already a pressing public 
health problem, and the United States must ensure that agricultural 
antibiotic use practices do not lead to antibiotic resistance in 
foodborne bacteria.
  Already, the CDC estimates that 410,000 antibiotic resistant 
Salmonella and Campylobacter infections occur each year. In fact, 
nearly 1 in 4 Campylobacter infections analyzed by the CDC is drug-
resistant.
  The CDC has also discovered that multidrug-resistant Salmonella 
results in more virulent infections, causing higher rates of 
hospitalization and bloodstream infections than normally expected with 
Salmonella infections. Clearly, more needs to be done to fight 
antibiotic resistance. This legislation will ensure that all medically 
important antibiotics approved for use in livestock feed and water pose 
no risk to human health due to the development of antibiotic 
resistance.
  In 2013, the Food and Drug Administration, FDA, took a critically 
important first step by issuing Guidance for Industry 213, a policy 
that will eliminate the use of antibiotics for feed efficiency or 
weight gain uses in food-animal production. I am glad that the 
pharmaceutical and agriculture industries plan to adopt FDA's policy. 
This is a victory for public health, and I am eager to see this policy 
fully implemented.
  However, FDA's judicious antibiotic use policy has a gap that must be 
addressed in order to fully protect public health. You see, many of the 
antibiotics previously approved for disease prevention and control are 
at high risk of abuse or misuse.
  Some of these approved uses are at similar low doses as the 
production uses being phased out by FDA judicious use policies. Other 
uses do not have a defined duration of use or aren't approved at a 
therapeutic dose expected to treat a specific bacterial pathogen.
  In fact, the FDA has informed my staff that there are likely 107 
antibiotics approved for disease prevention or control that fall into 
these categories. This is a problem as some producers may rely on these 
drugs far too often as a way to maintain animal production or to 
prevent recurrent infections when these important issues could be 
solved with better sanitation, biosecurity, and animal husbandry.
  This legislation would require pharmaceutical companies to submit 
additional information to the FDA to demonstrate that a disease 
prevention or control use of the drug does not pose a risk to human 
health due to the development of antibiotic resistance. It would apply 
only to antibiotics approved for disease prevention or control that are 
at high risk of overuse.
  If there is no risk to human health, the drug sponsor would also have 
to provide evidence to revise the conditions of using an antibiotic for 
disease prevention or control to ensure the drug is only used 
judiciously and sparingly. These revised drug approvals would be 
required to specify a therapeutic dose, be shown to control a specific 
bacterial infection, be targeted only to the group of animals at risk 
of developing a specific infection, and specify a defined duration of 
use.
  The bill also includes a sense of the Senate that all medically 
important antibiotics should be used only on the order of a licensed 
veterinarian who has a valid veterinarian-client-patient relationship 
with a producer.
  This means that the veterinarian is familiar with the animals to 
which he or she is prescribing an antibiotic. Veterinary oversight is a 
key component of ensuring that antibiotics are not used inappropriately 
or unnecessarily.
  This legislation, therefore, would allow for medically important 
antibiotics to be used to prevent or control infections when absolutely 
necessary and when it does not pose a risk to human health. In addition 
to protecting human health, this legislation will help to preserve the 
efficacy of antibiotic for veterinarians, so that the drugs will 
continue to be effective for treating livestock and poultry when no 
other alternatives to these drugs exist.
  Antibiotic resistance is a growing public health threat. If we do not 
act now, many more Americans will suffer and, in some cases, die from 
infections that are no longer treatable. This legislation will protect 
public health while

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allowing the agriculture sector to use antibiotics when absolutely 
necessary to preserve animal health. I ask my colleagues to work with 
me to enact this important bipartisan bill.
                                 ______