[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
[[Page S1219]]
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.
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