Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al

Filing 33

DECLARATION of Jennifer A. Sorenson in Support re: 19 MOTION for Summary Judgment.. Document filed by Center For Science In The Public Interest, Food Animal Concerns Trust, Natural Resources Defense Council, Inc., Public Citizen, Inc., Union Of Concerned Scientists, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I, # 10 Exhibit J, # 11 Exhibit K, # 12 Exhibit L, # 13 Exhibit M, # 14 Exhibit N, # 15 Exhibit O, # 16 Exhibit P, # 17 Exhibit Q, # 18 Exhibit R, # 19 Exhibit S, # 20 Exhibit T, # 21 Exhibit U, # 22 Exhibit V, # 23 Exhibit W, # 24 Exhibit X, # 25 Exhibit Y, # 26 Exhibit Z, # 27 Exhibit AA, # 28 Exhibit BB, # 29 Exhibit CC, # 30 Exhibit DD)(Sorenson, Jennifer)

EXHIBIT U
TO DECLARATION OF
JENNIFER A. SORENSON
FDA Website (Public Health Focus)

Public Health Focus > Antimicrobial Resistance

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http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm235649.htm

Home > News & Events > Public Health Focus

News & Events
Antimicrobial Resistance
Antimicrobial drugs have been widely used in human and veterinary medicine for more than 50 years, with tremendous benefits to
both human and animal health. The development of resistance to this important class of drugs, and the resulting loss of their
effectiveness as antimicrobial therapies, poses a serious public health threat. Misuse and overuse of antimicrobial drugs create
selective evolutionary pressure that enables antimicrobial resistant bacteria to increase in numbers more rapidly than antimicrobial
susceptible bacteria and thus increase the opportunity for individuals to become infected by resistant bacteria. Because
antimicrobial drug use contributes to the emergence of drug resistant organisms, these important drugs must be used judiciously in
both animal and human medicine to slow the development of resistance.
Dr Sharfstein Testimony 1
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Dr Woodcock Testimony 2
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Humans
Antibiotics are drugs used for treating infections caused by bacteria. Also known as antimicrobial drugs, antibiotics have saved
countless lives. Antibiotic resistance in humans and animals is a growing public health concern worldwide. When a person or
animal is infected with an antibiotic-resistant bacterium, treatment becomes more difficult because standard antibiotic therapies
become less effective or may not work at all. In an effort to combat antibiotic resistance, FDA has formed a task force to address
the issue of antimicrobial resistance that combines the talents of experts from around the agency. Leaders from within FDA have
also answered the call, including Dr Joshua Sharfstein, Principal Deputy Commissioner and Dr Janet Woodcock, Director for the
.
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Center for Drug Evaluation and Research, who have been raising awareness about antibiotic resistance in animals and people with
the American public.
When antibiotics don't work it may mean longer or more complicated illnesses, frequent doctor or veterinary visits, the use of
stronger and more expensive drugs with potentially serious side effects, and more deaths related to bacterial infections.
In cooperation with other government agencies, FDA has started several initiatives to address antibiotic resistance and has issued
drug labeling regulations emphasizing the prudent use of antibiotics, as well as implemented regulations for human use of
antibiotics that encourage health care professionals to prescribe the drugs only when clinically necessary.
To ensure optimal use, FDA recommends the following:
Don’t skip doses and do take your medicine as prescribed. Antibiotics are most effective when taken as prescribed.
Don’t save antibiotics. The drug is meant for a particular infection at that time. Don’t use leftover medicine. Taking the wron
drug can delay the appropriate treatment and your infection might get worse.
Don’t take antibiotics prescribed for others. Only a health care professional can determine the right treatment for your
infection.
3

More on
antibiotics 4
Combating
Antibiotic
Resistance 5
Resources for
You: Antibiotics
and Antibiotic
Resistance 6
Information by Drug Class: Antimicrobial Resistance 7
Public Health Focus: Antibiotic Resistance Podcast 8
Get Smart: Online Features, Podcasts, E-cards 9

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Use of Antimicrobials in Veterinary Medicine
Antimicrobial use in animals can contribute to the emergence of antimicrobial resistance which may be transferred to humans,
thereby reducing the effectiveness of antimicrobial drugs for treating human disease. CVM Antimicrobial Resistance 10 FDA believes
it is critically important that antimicrobial drugs be used as judiciously as possible in an effort to minimize resistance
development. Therefore, FDA has implemented a number of measures related to antimicrobial use in animals and is continuing to
develop strategies for addressing this public health issue. These activities include:

Judicious Use
FDA has worked collaboratively with veterinary and animal producer organizations to develop and distribute information to support
the judicious use of antimicrobial drugs in food-producing animals. Copies of these brochures are available at Judicious use of
antimicrobial drugs in food-producing animals brochures 11
In addition, FDA has developed a framework for policy regarding the judicious use of medically important antimicrobial drugs in
food-producing animals. This framework includes phasing in such measures as 1) limiting medically important antimicrobial drugs to
uses in food-producing animals that are considered necessary for assuring animal health; and 2) limiting such drugs to uses in
food-producing animals that include veterinary oversight or consultation. Collaboration involving the public, the public health,
animal health, and animal agriculture communities on the development and implementation of such strategies is needed. Draft
guidance is available at Judicious use of medically important antimicrobial drugs in food-producing animals (PDF - 76KB) 12

Pre-Approval Assessment of Antimicrobial Drugs
In 2003,FDA developed and implemented guidance for the animal drug industry for evaluating, as part of the animal drug approval
process, the potential development of antimicrobial resistance resulting from the use of antimicrobial new animal drugs in
food-producing animals. This FDA guidance is available at Guidance for animal drug industry (PDF - 131KB) 13

National Antimicrobial Resistance Monitoring System (NARMS)
FDA coordinates the NARMS program, a surveillance system that tracks antibiotic resistance in foodborne bacteria. The NARMS
program was established in 1996 as a partnership between the U.S. Food and Drug Administration (FDA), the Centers for Disease
Control and Prevention (CDC), and the U.S. Department of Agriculture (USDA).
NARMS monitors antimicrobial susceptibility among enteric bacteria from humans, retail meats, and food animals. Detailed
information regarding the NARMS program, including comprehensive annual reports, is available at National Antimicrobial Resistance
Monitoring System 14.

Antimicrobial Drug Sales/Distribution Summary Data
The Animal Drug User Fee Act of 2003 (ADUFA), amended the Federal Food, Drug, and Cosmetic Act (FFDCA) to require antimicrobia
drug sponsors to annually report to FDA the amount of antimicrobial active ingredient in their drugs that have been sold or
distributed for use in food-producing animals. ADUFA also requires FDA to summarize the sales and distribution information
received from drug sponsors each year to provide the summary report to the public. The first annual report (for 2009) is available
at Antimicrobial Drug Sales/Distribution Summary Data (PDF - 75KB) 15
FDA has also completed a report, Estimates of Antibacterial Drug Sales in Human Medicine 16, on antibacterial drug sales in human
medicine.

Additional Resources
National Antimicrobial Resistance Monitoring System 17

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Judicous Use of Medically
Important Antimicrobials in
Food Producing Animals 18
FDA 101:Animal Feed 19
CVM Reports on
Antimicrobials Sold or
Distributed for
Food-Producing Animals 20
Report on Antimicrobials
Sold or Distributed for
Food-Producing Animals (PDF - 75KB) 21

Links on this page:
1. /NewsEvents/Testimony/ucm219015.htm
2. /NewsEvents/Testimony/ucm214913.htm
3. /ForConsumers/ConsumerUpdates/ucm092810.htm
4. /ForConsumers/ConsumerUpdates/ucm092810.htm
5. /ForConsumers/ConsumerUpdates/ucm092810.htm
6. /Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/AntibioticsandAntibioticResistance/default.htm
7. /Drugs/DrugSafety/InformationbyDrugClass/ucm135344.htm
8. /NewsEvents/PublicHealthFocus/ucm233563.htm
9. http://www.cdc.gov/getsmart/campaign-materials/online-materials.html%0A%20%20%20%20
10. /AnimalVeterinary/SafetyHealth/AntimicrobialResistance/ucm2006489.htm
11. /AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/ucm2007130.htm
12. /downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM216936.pdf
13. /downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052519.pdf
14. /AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem
/ucm2006490.htm
15. /downloads/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/UCM231851.pdf
16. /Drugs/DrugSafety/InformationbyDrugClass/ucm261160.htm
17. /AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem
/default.htm
18. /AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/default.htm
19. /ForConsumers/ConsumerUpdates/ucm164473.htm
20. /AnimalVeterinary/NewsEvents/CVMUpdates/ucm236143.htm
21. /downloads/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/UCM231851.pdf

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