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Opinion and order granting summary judgment re growth promoter antibiotics

Opinion and order granting summary judgment re growth promoter antibiotics

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Published by marynmck
Text of the March 22, 2012 decision by Magistrate Judge Theodore H. Katz, case 1:11-cv-03562-THK, US District Court for the Southern District of NY, granting summary judgment to Natural Resources Defense Council et al. and denying request for summary judgment by US FDA et al.
Text of the March 22, 2012 decision by Magistrate Judge Theodore H. Katz, case 1:11-cv-03562-THK, US District Court for the Southern District of NY, granting summary judgment to Natural Resources Defense Council et al. and denying request for summary judgment by US FDA et al.

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Published by: marynmck on Mar 23, 2012
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03/23/2012

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UNITED STATES
DISTRICT
COURT
SOUTHERN
DISTRICT
OF
NEW
YORK
----------------------------------------X
NATURAL
RESOURCES
DEFENSE COUNCIL,
INC.,
et
al.,
Plaintiffs,
-against-
UNITED STATES
FOOD
AND
DRUG
ADMINISTRATION,
et
al.,
Defendants.
----------------------------------------x
THEODORE
H. KATZ, UNITED STATES MAGISTRATE JUDGE.
Plaintiffs
Natural
Resources
Defense
Council,
Inc.
("NRDC"),
Center
for
Science
in
the
Public
Interest,
Food
Animal
Concerns
Trust,
Public
Citizen,
and
Union
of
Concerned
Scientists,
Inc.
(collectively
"Plaintiffs")
bring
this
action
against
the
United
States
Food
and
Drug
Administration
("FDA"),
Margaret
Hamburg,
in
her
official
capacity
as
Commissioner
of the
FDA,
the
Center
for
Veterinary
Medicine
("CVM"),
Bernadette
Dunham,
in
her
official
capacity
as
Director
ofthe
CVM,
United
States
Department
of
Health
and
Human
Services
("HHS"),
and
Kathleen
Sebelius,
in
her
official
capacity
as
Secretary
of
HHS,
alleging
that
the
FDA
withheld
agency
action
in violation
of the
Food,
Drug,
and
Cosmetic Act
("FDCA"),21
U.S.C.
§
360b(e)
(1),
and
the
Administrative
Procedure
Act
("APA"),
5
U.S.C.
§
706(1).
The
parties
have
consented
to
trial
1
11
civ.
3562(THK)
MEMORANDUM
OPINION
AND
ORDER
Case 1:11-cv-03562-THK Document 70 Filed 03/22/12 Page 1 of 55
 
before
this
Court,
pursuant
to
28
U. S . C.
§
before
the are
the
part
cross-mot~:
for
summary
ourt
s
ck
judgment.
For
the
reasons
that
follow,
motion
is
granted
and
Defendants'
motion
is
denied.
BACKGROUND
1
I.
Overview
For
over
thirty
years, the
FDA
has
taken
the
si
tion
that
the
widespread
use
of
certain antibiotics
in
lives
for
purposes
other
than
disease
treatment
poses
a
threat
to
health.
In
1977,
the
FDA
issued
notices
announcing
its
in~~nt
to
withdraw 
approval
of
the
use
of
certainantibiotics
in
I~vestock
for
the 
purposes
of
growth
promotion
and
feed
efficiency,
I
Which
the
agencyhad
found
had
not
been
proven
to
be
safe.
The:
FDA
issued thenotices
pursuant
to
21
U.S.C.
§
360b(e)
(1),
whic~
states
that
[t]he Secretary
shall,
after
due
notice
and
opportunity
for
hearing
to
the
applicant, issue
an
order
withdrawing
approval
of
an
application
...
with
respec
Jto
any
new
animaldrug
if
theSecretary
finds
.
(i8)
that
new
evidence
not
contained
in
such
applicat1pn or
not
available
to
the
Secretary
until
after
suchi.pplication
was
approved,
or
tests
by
new
methods,
1~
tests
bymethods
not
deemed
reasonably
applicable
iwhen
such
application
was
approved,
evaluatedtogeth
t:
with
the
evidence
available to
the Secretary
when
the
4pplication
, !
1
Except
where
otherwise noted,
the
following
facts,
derived
from
the
parties'
Statements
Pursuant
to
LocalCIVil
Rule
56.1,
are
undisputed.
2
Case 1:11-cv-03562-THK Document 70 Filed 03/22/12 Page 2 of 55
 
was
approved,
shows
that
such
drug
is
not
ishown
to
be
safe
for
use under
the conditions
of
use
up6n
the
basis
of
which
the
application
was
approved
.
21
U.S.C.
§
360b(e)
(1)
(B).
Although
the
noticFs
were
properly
I
I
promulgated
and
over
twenty drug
sponsors
requested
hearings
on
the
matter,
the
FDA
never
held
hearings
or
took
any
furtheraction
on
the
proposed
withdrawals.
In the
intervening years,
the
scientific
eVi4ence
of
the
risks
to
human
health
from
the
widespread
useof
antibiotics
in
livestock
has
grown,
and
there
is
no
evidence
that
the
FD~
has
changed
its
position
that
such
uses
are
not
shown
to
be
safe.
In
May
2011,
after
the
FDA
failed
to
respond
to
two
Citizen
Pet~tions
urging
the
agency
to
follow
through
with
the
1977
notices,Plaintiffs
filed
this
action
seeking
a
courtorder
compelling
the
FDA
to
complete
the
withdrawal
proceedings
for
antibiotics
included
in
the
1977
notices.
In
December
2011,
the
FDA
withdrew
the
original
notices
on
the
grounds
that
they
were
outdated,
and
it
now
argues
that
Plaintiffs'
claim
is
moot.
II.
Use
of
Antibiotics
in
Food-Producing
Animals
Antibiotics, also
known
as
antimicrobials,
4re
drugs used
to
treat
infections
caused
by
bacteria.
Al
though
'antibiotics
have
saved
countless
lives,
the
improper
use
and
overuse
of
antibiotics
has
led to
a
phenomenon
known
as
antibiotic
resistance.
3 
Case 1:11-cv-03562-THK Document 70 Filed 03/22/12 Page 3 of 55

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