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 S
TO DECLARATION OF
JENNIFER A. SORENSON
FDA Consumer Health Information (2010)

Consumer Health Information
www.fda.gov/consumer

Combating
Antibiotic
Resistance
A

ntibiotics are drugs used for treating
infections caused by bacteria. Also known
as antimicrobial drugs, antibiotics have
saved countless lives.
Misuse and overuse of these drugs, however, have
contributed to a phenomenon known as antibiotic resistance. This resistance develops when potentially harmful
bacteria change in a way that reduces or eliminates the
effectiveness of antibiotics.
A Public Health Issue
Antibiotic resistance is a growing public health concern
worldwide. When a person is infected with an antibioticresistant bacterium, not only is treatment of that patient
more difficult, but the antibiotic-resistant bacterium may
spread to other people.
When antibiotics don’t work, the result can be
• longer illnesses
• more complicated illnesses
• more doctor visits
•  he use of stronger and more expensive drugs
t
•  ore deaths caused by bacterial infections
m
Examples of the types of bacteria that have become
resistant to antibiotics include the species that cause skin
infections, meningitis, sexually transmitted diseases and
respiratory tract infections such as pneumonia.
In cooperation with other government agencies, the
Food and Drug Administration (FDA) has launched several initiatives to address antibiotic resistance.
The agency has issued drug labeling regulations,
emphasizing the prudent use of antibiotics. The regulations encourage health care professionals to prescribe
antibiotics only when clinically necessary, and to coun-

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Health care professionals should prescribe antibiotics only
for infections they believe to be caused by bacteria. Patients
should not demand antibiotics when a health care professional
says the drugs are not needed.

sel patients about the proper use of such drugs and the
importance of taking them as directed. FDA has also
encouraged the development of new drugs, vaccines, and
improved tests for infectious diseases.
Antibiotics Fight Bacteria, Not Viruses
Antibiotics are meant to be used against bacterial infections. For example, they are used to treat strep throat,
which is caused by streptococcal bacteria, and skin infections caused by staphylococcal bacteria.
Although antibiotics kill bacteria, they are not effec-

1 / FDA Consumer Health Infor mat ion / U. S. Food and Drug Administrat ion

UPDAT ED D ECEMBER 2010

Consumer Health Information
www.fda.gov/consumer

Although antibiotics kill bacteria, they are
not effective against viruses.
tive against viruses. Therefore, they
will not be effective against viral
infections such as colds, most coughs,
many types of sore throat, and influenza (flu).
Using antibiotics against viral
infections
• will not cure the infection
•  ill not keep other individuals
w
from catching the virus
• will not help a person feel better
•  ay cause unnecessary, harmful
m
side effects
•  ay contribute to the
m
development of antibiotic-resistant
bacteria
Patients and health care professionals alike can play an important role
in combating antibiotic resistance.
Patients should not demand antibiotics when a health care professional
says the drugs are not needed. Health
care professionals should prescribe
antibiotics only for infections they
believe to be caused by bacteria.
As a patient, your best approach is
to ask your health care professional
whether an antibiotic is likely to be
effective for your condition. Also, ask
what else you can do to relieve your
symptoms.
Follow Directions for Proper Use
When you are prescribed an antibiotic to treat a bacterial infection, it’s
important to take the medication
exactly as directed. Here are more tips
to promote proper use of antibiotics.
• C omplete the full course of the

drug. It’s important to take all of the
medication, even if you are feeling
better. If treatment stops too soon,

the drug may not kill all the bacteria. You may become sick again,
and the remaining bacteria may
become resistant to the antibiotic
that you’ve taken.
D
•  o not skip doses. Antibiotics are
most effective when they are taken
regularly.
• Do not save antibiotics. You might

think that you can save an antibiotic
for the next time you get sick, but
an antibiotic is meant for your particular infection at the time. Never
take leftover medicine. Taking the
wrong medicine can delay getting
the appropriate treatment and may
allow your condition to worsen.
• Do not take antibiotics prescribed

for someone else. These may not
be appropriate for your illness, may
delay correct treatment, and may
allow your condition to worsen.
• Talk with your health care profes
sional. Ask questions, especially if
you are uncertain about when an
antibiotic is appropriate or how to
take it.
It’s important that you let your
health care professional know of any
troublesome side effects. Consumers and health care professionals can
also report adverse events to FDA’s
MedWatch program at 800-FDA-1088
or online at www.fda.gov/medwatch/
report.htm.

statements in several places advising health care professionals that
these drugs should be used only
to treat infections that are believed
to be caused by bacteria. Labeling
also encourages health care professionals to counsel patients about
proper use.
• P ar tnering to promote public

awareness. FDA is partnering with
the Centers for Disease Control and
Prevention (CDC) on “Get Smart:
Know When Antibiotics Work,” a
campaign that offers Web pages,
brochures, fact sheets, and other
information sources aimed at helping the public learn about preventing antibiotic-resistant infections.
•  ncouraging the development of
E
new antibiotics. FDA is actively
engaged in developing guidance
for industry on the types of clinical
studies that could be performed to
evaluate how an antibacterial drug
works for the treatment of different
types of infections.
Find this and other Consumer
Updates at www.fda.gov/
ForConsumers/ConsumerUpdates
Sign up for free e-mail
subscriptions at www.fda.gov/
consumer/consumerenews.html

What FDA Is Doing
FDA combating antibiotic resistance
through activities that include
•  abeling regulations addressing
L
proper use of antibiotics. Antibiotic labeling contains required

2 / FDA Consumer Health Infor mat ion / U. S. Food and Drug Administrat ion

UPDAT ED D ECEMBER 2010