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

Filing 95

MEMORANDUM OPINION AND ORDER # 101877. For the reasons in this Memorandum Opinion and Order, Plaintiffs' motion for summary judgment on their third claim for relief is granted and Defendants' motion for summary judgment is denied. The Court remands the matter to the Agency for further proceedings consistent with this Opinion. The Court emphasizes that it is not compelling the Agency to reach a certain conclusion. The Court simply finds that the Agency's proffered grounds for denying the Petitions were arbitrary and capricious. Re: 63 MOTION for Summary Judgment on Plaintiffs' First Supplemental Complaint filed by Margaret Hamburg, Kathleen Sebelius, Bernadette Dunham, United States Food and Drug Administration, United States Department of Health and Human Services, Center for Veterinary Medicine, 56 MOTION for Summary Judgment on Plaintiffs Third Claim for Relief filed by Union Of Concerned Scientists, Inc., Public Citizen, Inc., Natural Resources Defense Council, Inc., Center For Science In The Public Interest, Food Animal Concerns Trust. (Signed by Magistrate Judge Theodore H. Katz on 6/1/2012) (rjm) Modified on 6/6/2012 (ft).

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
NATURAL RESOURCES DEFENSE COUNCIL,
INC., et
.,
11 Civ. 3562 (THK)
Plaintiffs,
MEMORANDUM
OPINION AND ORDER

-againstUNITED STATES FOOD AND DRUG
ADMINISTRATION, et al.,

Defendants.

------------- X
THEODORE H. KATZ, UNITED STATES MAGISTRATE JUDGE.
On March 22,

2012,

this Court granted summary judgment to

Plaintiffs Natural Resources Defense Council, Inc. ("NRDC")
for Science in the Public Interest ("CSPI"),

I

Center

Food Animal Concerns

Trust (\IFACT"), Public Citizen, and Union of Concerned Scientists,
Inc.

(\lUCS"),

rel

f.

(collectively "Plaintiffs") on their f

t claim for

See Natural Res. Def. Council v. United States Food & Drug
("NRDC I"), No. 11 Civ. 3562 (THK) , 2012 WL 983544, at *20

(S.D.N.Y.

Mar.

22,

2012).

The Court determined that Defendants

United States Food and Drug Administration

("FDA" or "Agency"),

capacity as Commissioner of the

Margaret Hamburg, in her offic

FDA, the Center for Veterinary Medicine ("CVM"), Bernadette Dunham,
her official capacity as
Department

of

tor of the CVM,

Health and Human Services
1

("HHS") ,

United States
and Kathleen

Sebelius, in her official capacity as Secretary of HHS, unlawfully
withheld

agency

action

by

failing

to

implement

withdrawal

proceedings pursuant to the Food, Drug, and Cosmetic Act (\\FDCA"),
U.S.C.

21

360b{e) ,

§

for

certain

uses

of

penicillin,

oxytetracycline, and chlortetracycline in food-producing animals.
id.

Presently be

the Court are the parties' cross motions

for summary judgment on Plaintiffs' third claim
alleges

that

the

FDA acted in violation of

Procedure Act (nAPA"), 5 U.S.C.
§

360b(e}, when

FDA

withdraw

§

the Administrative

706(2), and the FDCA, 12 U.S.C.

denied two Citizen Petitions requesting that the

approval

of

certain

uses

antibiotics in food-producing animals.

of

certain

The part

to trial before this Court, pursuant to 28 U.S.C.
the

reasons

that

relief, which

follow,

Plaintiffs'

motion

classes

of

s have consented
§

is

636(c).

For

granted

and

Defendants' motion is denied.
BACKGROUND 1

I.

Statutory and Regulatory Background
A.

The Food, Drug, and Cosmetic Act

The FDCA empowers the FDA to regulate drugs sold in interstate

The Court assumes familiarity with the history of
antibiotic use in food-producing animals, as it was discussed
extens
in the March 22, 2012 decision. Accordingly, only
the facts necessary for the disposition of the current
spute
will be discussed.
2

,14;,

commerce, including veterinary drugs.
conjunction with this authority,

See 21 U.S.C.

§

393(b).

In

the FDA is required to "promote

the public health" and to ensure that "human and veterinary drugs
are safe and effective."

21 U.S.C. § 393 (b) (1)

(2).

Specifically,

pursuant to the FDCA, the FDA must approve the use or intended use
of any "new animal drug"
§

360b(a) (1)

("NADA")

and the labeling thereof.

See 21 U. S. C.

Any person may submit a new animal drug application

to the FDA for approval of the use or intended use of a

new animal drug; the application must include sufficient evidence
of

the

drug's

ty and efficacy,

including

1

"

reports

of

investigations which have been made to show whether or not such
drug is safe and effective for use[.]"
In general,

21 U.S.C.

360b(b) (1) (A).3

§

the FDA will approve a NADA unless the agency finds

that the drug use has not been shown to be safe or effective.
12 U.S.C.

§

360b(d) (1); 21 C.F.R.

§

514.1(b) (8) (i).

Once the FDA has approved the use of a new animal drug,
applicant

holder

must

make

periodic

reports

to

the

Agency

describing experience with the drug and any new research into the
drug's safety and effectiveness.

See 21 C.F.R.

§

514.80(a) (2).

2 A new animal drug is defined,
in part, as "any drug
intended for use for animals other than man,
luding any drug
intended for use in animal feed but not including such animal
feed
See 21 U.S.C. § 321(v).
.ff

3 Any person may file an abbreviated new animal drug
application ("ANADA") for approval of a generic animal drug.
3

The

FDA

reviews

these

periodic

reports

to

determine

whether

approval of the drug use should be suspended or withdrawn pursuant
to 21 U.S.C.
360b(e) (1)

§

360b(e).

See 21 C.F.R.

§

514.80(a) (3).

requires the FDA to withdraw approval

drug if it finds that,
shown to be safe . .

based on new evidence,
If

See 21 U.S.C.

§

Section

a new animal

the

360b(e) (1)

"drug is not
(B)."

The FDA

must provide notice of an opportunity for a hearing ("NOaH") to a
drug applicant prior to issuing a withdrawal order.
§

See 21 U.S.C.

36 Ob (e) (1) .
B.

Regulation of Antibiotics in Food-Producing Animals

In the 1950s,

the FDA approved applications for the use of

various antibiotics in food producing animals for a variety of non
disease

treatment

efficiency,

purposes,

including

and disease prevention.

growth

promotion,

For these uses,

feed

antibiotics

were approved to be administered on a herd- or flock wide basis at
doses lower than those traditionally used to treat disease.
the Agency first approved these uses of antibiotics,

litt

When
was

known about the development of antibiotic resistant bacteria or the
role

of

agricultural

use

of antibiotics

in the

development of

resistant bacteria.

4
Section 360b(e) (1) lists six findings by the Agency that
prompt withdrawal.
21 U.S.C. § 360b(e) (1) (A)-(F).
The most
relevant findings for the present action are those described in
sUbsection (B).

4

it ¥

f a

However,

ific evidence had emerged

by the late 1960s sc

linking the widespread use of antibiotics in food-producing animals
antibiotic-resistant bacteria.

at low doses with the development
In

1970,

the

FDA

convened

a

task

force

to

study

the

risks

associated with the use of antibiotics in animal feed.

The task

force

National

was

composed

Institutes
Centers

of

for

of

Health,

Disease

scientists
the U.S.

Control,

universit

the

FDA,

Department

as

well

as

of

concluding that:

(1)

the

Agriculture,

representatives

In 1972, the task

s and industry.

findings,

from

the
from

e published its

the use of antibiotics in animal

feed, especially at doses lower than those necessary to prevent or
treat

disease,

favors

the

development

of

antibiotic-resistant

bacteria; (2) animals receiving antibiot

s in their feed may serve

as a reservoir of antibiotic pathogens,

which can produce human

infections;

(3) the prevalence of bacteria carrying transferrable

resistant genes for multiple antibiotics had increased in animals,
and

the

increase

was

related

to

the

use

of

antibiotics i

antibiotic-resistant bacteria had been found on meat

(4)

and meat

products; and (5) the prevalence of antibiotic resistant bacteria
in humans had increased.
Animal Feeds,
task

force

antibiot

See Antibiotic and Sulfonamide Drugs in

37 Fed. Reg.

made

several

2,444,

2/444 45

recommendations,

(Feb. 1,

1972).

including

that

The
(1)

s used in human medicine be prohibited from use in animal
5

feed unless they met safety criteria established by the FDA, and
(2)

several specific antibiotics be reserved for therapeutic use

unless they met safety

teria for non-therapeutic use.

See id.

at 2,445.
In response to the findings of the task force,

the FDA,

1973, issued a regulation providing that the Agency would propose
to withdraw approval of all subtherapeutic uses of antibiotics in
animal

feed

submitted

unless

data

drug

within

sponsors
the

next

and other
two

years

interested parties
"which

resolve[d]

conclusively the issues concerning [the drugs'] safety to man and
animals

.

. under specific criteria" established by the FDA.

Antibiotic and Sulfonamide Drugs in the Feed of Animals,
Reg. 9,811, 9,813 (Apr. 20, 1973)
135.109;

renumbered at

21

C.F.R.

38 Fed.

(codified at former 21 C.F.R.
§

558.15).

One of

§

the most

important of the human and animal health safety criteria that the
FDA established for drug safety evaluations involved the transfer
of antibiotic resistant bacteria from animals to humans.

The FDA

required that "[a]n antibacterial drug fed at subtherapeutic levels
to animals must be shown not to promote increased resistance to
antibacterials

used

in human medicine."

Premixes Notice ("Penicill
(Aug. 30, 1977).

Penicillin-Containing

Notice"), 42 Fed. Reg. 43,772, 43,774

The other health safety criteria involved showing

that use of antibiotics would not increase salmonella in animals,
6

would not increase the pathogenicity of bacteria,
increase

residues

in

food

ingested

by

man,

and would not

which

may

cause

"increased numbers of pathogenic bacteria or an increase in the
resistence of pathogens
medicine. "

to antibacterial

used

in human

See

Over the next two years,
("BVM"),

agents

the Bureau of Veterinary Medicine

a subdivision of the FDA,

reviewed the data submitted by

drug sponsors to support the subtherapeutic use of antibiotics.
April

20,

cri teria
43,774.

1975,

all

data

for antibiotic

concerning

drugs

the

safety

and

By

efficacy

had been received.

The FDA took no immediate action after receiving the data

other than, in 1977, issuing notices proposing to withdraw approval
of

all

subtherapeutic

Penicillin Notice,
exceptions,

all

in

(Chlortetracycline
for

Fed.

of
Reg.

subtherapeutic

chlortetracycl

Opportunity

42

uses

and

Hearing

1

penicillin

in

at

and,

43,772,

uses

of

livestock,
with

limited

oxytetracycline

stock.

see

and

Tetracycline

Oxytetracycline}-Containing

Premises;

("Tetracycline

Fed.

56,264, 56,264 (Oct. 21, 1977).

Notice"),

42

Reg.

Although the notices were properly

promulgated and over twenty drug sponsors requested hearings on the
matter, the FDA never held hearings or took any further action on

The BVM was renamed the Center for Veterinary Medicine
("CVM") in 1984.
7

the proposed withdrawals. 6
Since 1977, the evidence of the
antibiotic-resistant
antibiot

bacteria

and

sks to human health posed by
the

link

between

low-dose

use and the development of resistant-bacteria has grown.

Nevertheless, with limited exceptions,

the FDA has not withdrawn

approval of the subtherapeutic use of antibiotics in food-producing
animals. 7
documents

Instead, the FDA has issued several non-binding guidance
for

industry

to

promote

the

judicious

use

of

antibiotics. S
6 The FDA's
lure to complete the withdrawal proceedings
for penicillin, chlortetracycline, and oxytetracycline was the
subject of Plaintiffs' first claim for relief.
On March 22,
2012, this Court ordered the Agency to complete these withdrawal
proceedings.
NRDC I, 2012 WL 983544, at *20.
7 For example,
in 2005, the Agency withdrew approval of the
use of enrofloxacin, an antimicobrial drug within a class of
drugs known as fluoroquinolones, in poultry.
Enroloxacin for
Poultry; Final Decision on Withdrawal of New Animal Drug
Application Following Formal Public Evidentiary Hearing;
Availabili , 70 Fed. Reg. 44,105, 44,105 (Aug. I, 2005).

8 Specifically,
in 2003, the FDA released Guidance for
Industry # 152, which established a risk assessment to evaluate
the risks posed by the subtherapeutic use of antibiotics in food­
producing animals.
Administrative Record ("Rec. n ) at 131.)
The risk assessment was intended to be utilized by drug sponsors
in the appl ation process, and thus had no effect on already
approved NADAs/ANADAs.
In 2010, the FDA released Draft Guidance
Industry # 209 ("Draft Guidance # 209"), which established
non-binding principles for the judicious use of antibiotics in
food-producing animals.
(See id. at 167.)
Specifically,
Guidance # 209 recommended that "[t]he use of medically important
antimicrobial drugs in food-producing animals should be limited
to those uses that are considered necessary for assuring animal
health[,]" and "to those uses that include veterinary oversight

8

II.

The Citizen Petitions
The

issue

response

to

presently

two

respectively.

Citizen
Both

before

the

Petitions,

Petitions

Court

involves

the

FDA's

filed

in

1999

and

2005,

that

the

FDA

begin

requested

withdrawal proceedings for all non-therapeutic uses of medical
important antibiotics
A.

food producing animals.

The 1999 Citizen Petition

On March 9, 1999, four of the named Plaintiffs,

CSPI,

FACT,

Public Citizen, and UCS, as well as the Environmental Defense Fund,
submitted

a

Citizen

Petition

("1999

Petition")

to

the

FDA

requesting that the agency "rescind approvals for subtherapeutic
uses in livestock of any antibiotic used in (or related to those
used in) human medicine."
4 5.)

The

1999

(See Administrative Record ("Rec.", at

Petition defined

"subtherapeutic

use"

as

"administration of [antibiotics] at a dosage less than is necessary
and/or for a period of time longer than is necessary to treat an
infection",
promotion,

(id. at 8), including use of such drugs for "growth
improved feed eff

iency,

and disease prevention.,,9

or consultation."
(Id. at 182-83.) Draft Guidance # 209 was
finalized on April 13, 2012.
(See Ex. A to the Declaration of
Amy A. Barcelo, dated Apr. 16, 2012 ("Third Barcelo Declo").)
The 1999 Petition explained that "[t]he FDA defines
subtherapeutic use as the use of antibiotics in livestock for
more than 14 days."
(Rec. at 8.)
9

(Id. at 5.)
all

Although the 1999 Petition sought broad withdrawal of

subtherapeutic

uses

antibiotics

that

are

also

used

in

humans, it named several specific classes of antibiotics for which
it

sought

withdrawal,

including

penicillin,

tetracyclines,

erythromycin, lincomycin, tylosin, and virginiamycin.

(See id. at

5. )

The bulk of the 1999 Petition was devoted to a discussion of
the scientific evidence indicating that the subtherapeutic use of
antibiotics in food-producing animals poses a

sk to human heal th.

Citing numerous peer-reviewed studies,lO the 1999 Petition discussed
the widespread subtherapeutic use of antibiotics in livestock; the
evidence

that

such

use

leads

to

the

selection

of

antibiotic

resistance; the evidence that antibiotic-resistant bacteria can be
transferred between animals and between animals and people;

the

evidence that antibiotic-resistant bacteria may transfer resistant
genes to other bacteria; the evidence that the subtherapeutic use
of antibiotics may select for multi-drug resistant bacteria that
can cause infections that are more deadly and difficult to treat;
the evidence that nontherapeutic antibiotic use

jeopardizes the

therapeutic options in veterinary and human medicine; the evidence
that

the

subtherapeutic

use

of

antibiotics

reduces

the

The 1999 Petition cites over twenty articles from leading
science and microbiology journals.
10

f,;:;;;~.·

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

effectiveness of new human-use antibiotics i
other

countries,

antibiot

that

decreasing

the

and evidence,

subtherapeutic

use

from
of

s in food-producing animals can reduce the prevalence of

antibiotic resistant bac

and does not adversely affect animal

health.
1.

FDA's Response to the 1999 Petition

The FDA issued a tentative response to the 1999 Petition on
Rec. at 50.)

August 19, 1999.

sed in [the] citizen petition

currently considering the issues
(See

"

However,

the action requested

The FDA stated that it "is

" [b]ecause of the complex nature of

[in the citizen pet

careful and thorough sc

ific,

analysis

wthin

and

additional

coordination

time

a

comments
document,

issue

id. )

petition."
issue

to

final

on

numerous

which requires

, and policy consultation,
the

final

agency,

FDA

response

to

will

require

[the]

citizen

Specifically, the FDA stated that it would

response

received

a

ion],

after
[the]

completing
citizen

consultations

and

scientific, legal and policy issues."

an

"analysis

petition,
the

the

resolution

of

the

framework
of

the

id. )

The FDA issued a second tentative response on February 28,
2001.

(See

at

51.)

The

FDA explained

the

process

for

withdrawing approval of a new animal drug, emphasizing that "the
petitions can only be granted or denied on a drug by drug basis as
11

f;':ii-_

reviews are completed and resources permit.
described the findings neces

at 52.)

11

The FDA

to trigger a withdrawal and

regulatory requirements for holding a hearing prior to withdrawing
approval of a NADA/ANADA.

The FDA explained

its "experience

with contested, formal withdrawal proceedings is that the process
can consume extensive periods of time and Agency resources."
at 52.)

The FDA discussed its other strategies for addressing

antibiotic use

food-producing animals,

Industry # 78,

including Guidance for

"which addresses how FDA intends to consider the

potential human health impact of the microbial effects associated
with all uses of antimicrobial new animal drugs in food producing
animals when approving such drugs,"
e

and a

"framework document

II

ishing a risk-based framework for evaluating the microbial
of the use of antimicrobial drugs in food-producing animals.
at 53.)

The FDA again stated that it could not issue a

final decision until it had completed an analysis of the "comments
received

on

[the]

citizen

numerous

consultations,

and

legal, and policy issues."
2.

the

the

issued

its

resolution of

final

response

!, i

to

the

the

on November 7,

Document,

sc

ific,

1999

2011,

Peti tion,
during the

The FDA recounted the history of its
12

1

Framework

(Id. at 54.)

requested action,

pendency of this action.

t

the

FDA's Final Response to the 1999 Petition
FDA

denying

petition,

handling of the 1999 Petition,

including

earlier statements

that it would not issue a final decision until the "FDA makes a
decision about whether to withdraw the drug approvals listed in the
petition.
from

(See id. at 71.)

1/

the

1999

Petition

The FDA

whether

that it was unclear

the

action

requested

was

to

immediately issue a withdrawal order or to initiate withdrawal
proceedings,

(See id. at 72.)

actions.
issue

a

and the Agency proceeded to discuss and deny both

withdrawal

order

The FDA explained that it could not
for

the

Petition " [b]ecause no [withdrawal]

drugs

included

in

the

1999

hearings have been held with

respect to the animal drugs at issue in the Citizen Petition, and
. the Commissioner has not made any final determination about
whether grounds for withdrawal under
been satisfied

/I

Moreover, the FDA re

[21 U.S.C.

§

360b(e}]

at 73.}
to initiate withdrawal proceedings.

The FDA offered two justifications for this decision.
FDA cited the time and
at 73.}

hearing.
pursuing a
antibiotics

different

have

First, the

involved in holding a withdrawal
Second, the FDA explained that it was
to promote the

food-producing animals.

judicious use of
Specifical

the FDA cited Draft Guidance # 209, entitled "The Judicious Use of
Medically Important Antimicrobial Drugs in Food-Producing Animals,
which recommends 1

ting the use of antibiotics in food-produc
13

/I

(See

animals to judicious uses.

Draft Guidance # 209 states

that the FDA does not consider growth promotion or feed eff
to be

judicious uses.

recommends

(See

Draft

iency

# 209 also

Guidance

the use of medically-important antibiotics

producing

s

that

lude

veterinary oversight or consultation."

(See id. at 74.)

The FDA

explained

[the

that

should

"[b]ased

be

on

limited

to

feedback

[regarding Draft Guidance # 209],

"uses

food­

FDA]

has

received

FDA believes that the animal

pharmaceutical industry is generally responsive to the prospect of
working cooperatively with the Agency to implement the principles
recommended in [the Draft Guidance] ."

(Id.)

The FDA stated that

it planned to phase-out over-the counter use of medical

important

antibiotics in animal feed and move to a veterinary feed directive
("VFD") status for such drugs.

The FDA also stated that it planned

to work cooperatively with industry to achieve this transition.
"FDA believes

that

the

strategy

set

out

in draft

guidance #209 is a pathway to achieving the same goals as those
advocated in [the 1999 Petition]
FDA

refused

to

initiate

"

withdrawal

(Id.)

Accordingly, the

proceedings

for

the

drugs

included in the 1999 Petit
B.
On

The 2005 Citizen Petition
April

7,

2005,

named

Plaintiff

DeS,

as

well

as

the

Environmental Defense Fund, the American Academy of Pediatrics, and
14

;' i "

the American Public Health Association,

filed a Citizen Petition

("2005

withdraw

Petition")

with

herdwide/flockwide

uses

the
of

FDA

"to

[certain

approvals

antibiotics]

in

11

for

chicken,

swine, and beef cattle for purposes of growth promotion (including
weight gain and feed efficiency) and disease prevention and control
(except for non-routine use where a bacterial infection has been
diagnosed wi thin a

herd or

flock) [.]"

(Id.

at

75.)

The

2005

Petition did not seek "withdrawal of disease prevention or disease
control uses where a drug is administered to individual animals, or
to

select

groups

administered

in

or

pens

response

to

of
a

animals,

or

where

2005

wi thdrawal

of

drug

diagnosed outbreak of

disease within a building, house, or feedlot."
The

a

Petition

emphasized

that

its

approval

of

uses

of

certain

is

bacterial

(Id. at 76.)
requested

action,

certain medically-

important antibiotics, was designed in accordance with the FDA's
Guidance for Industry # 152

("Guidance #152").

This Guidance,

issued on October 23, 2003, established criteria for evaluating the
safety

of

agricultural

antibiotics

with

regards

to

antibiotic

resistance when considering new animal drug applications.

(See id.

11 The
2005 Petition applied to penicillins, tetracyclines,
aminoglyosides, streptogramins, macrolides, lincomycin, and
sulfonamides.
(Rec. at 75.)

15

- - - - - - - - - - - - - - m ! !_____________________

"t;:j:

~,{A·

at 76.)

12

Similar to the 1999 Petition,

comprehensive sci

the 2005 Petition presented a

ific basis for its requested action.

the 2005 Petition explained the background of antibiot
and the agricultural use of antibiot
2005 Petition then discussed

s.

(See

First,

resistance

at 77-80.)

The

development of Guidance # 152 and

the legal standard for the FDA to withdraw approval of a new animal
drug application.

id. at 80 83.)

The 2005 Petition then

presented scientific evidence that the approved uses of antibiotics
covered in the Petition are not consistent with the safety criteria

Guidance # 152, entitled "Evaluating the Safety of
Antimicrobial New Animal Drugs with Regard to Their
Microbiological Effects on Bacteria of Human Health Concern[,]"
provides a "risk assessment approach
evaluating the microbial
food safety of antimicrobial new animal drugs."
(Rec. at 133.)
The
sk assessment provided in Guidance # 152 presented a means
drug applicants to demonstrate that new animal drugs meet the
human health safety requirement in the NADA approval process.
(See Rec. at 133.)
Specifically, the risk assessment involved
characterizing the hazard and then providing: (1) a release
assessment - the probability that resistant bacteria are present
in the target animal as a consequence of drug use (ranked as
high, medium, or low) i (2) an exposure assessment - the
probability for humans to ingest bacteria in question from the
relevant food commodity (ranked as high, medium, or low) i and (3)
a consequence assessment - the probability that human exposure to
resistant bacteria results in an adverse health consequence
(ranked as important, highly important, or critically important) .
(See id. at 137.)
These assessments are used to provide an
overall risk assessment, which is ranked as high, medium, or low.
(See
The risk assessment provided in Guidance # 152 was only
a suggestion, not a
rement, and only applicable to new
animal drug applications.
12

16

ml--~

ln Guidance
explained

# 152.

that,

at

pursuant

to

83 89.)

Guidance

#

The
152,

2005

Petition

only

low risk

antibiotic drugs should be administered to food-producing animals
on a flock-wide or herd-wide basis.
teria

set

forth

in

sk based on their re
at 85-89.)

#

Guidance

demonstrated that the antibiot
low-

at 84 85.)

Moreover,

the

152,

2005

Using the
Petition

s covered by the Petition are not
, exposure, and consequence.

use of the antibiotics covered in the

2005 Petition in chicken, swine, or beef cattle results in a high

or medium-risk.

(See id. at 89.)

The 2005 Petition concluded by

repeating its request that FDA begin withdrawal proceedings for
herd wide and flock wide uses of critically important and highly
important antibiotics in chicken, swine, and beef cattle.

id.

at 89.)
FDA's Initial Response to the 2005 Petition

1.

The FDA provided a tentative response to the 2005 Petition on
October 4, 2005.
action requested

Rec. at 124.)

The response summarized the

withdrawal of medically-important antibiotics

based on the criteria presented in Guidance # 152

and explained

that

required

to

withdraw

completion of

approval

of

two processes.

a

new animal

{See

drug

First,

the

CVM must

determine whether to initiate formal withdrawal proceedings.
id. )

Second,

if the CVM decides to init
17

the

(See

formal withdrawal

proceedings, the Agency must then undertake the formal withdrawal
procedures required by statute, including providing notice and an
opportuni ty of a hearing to the drug sponsor.

(See

The

response stated:

For legal, scientific and resource reasons, withdrawal
actions for the petitioned drugs need to be considered on
a drug by drug basis. Data and information will need to
be reviewed and analyzed for each drug.
Thus, the
petitions can only be granted or denied on a drug by drug
basis as reviews are completed and resources permit.
(rd. )
The FDA then explained that to initiate formal withdrawal
proceedings one of
satisfied.

the grounds

(See

listed in

§

360b (e) (1)

must be

The FDA detailed the administrative process

required to withdraw approval of
issuing a notice for each drug,

a

new animal

drug,

including

providing an opportunity for a

formal evidentiary hearing, and the right to appeal the decision
made by a hearing officer.

(See

at 125.)

formal withdrawal proceedings may take
consume

extens

agency resources.

The FDA noted that
to complete and may
The

FDA then

explained its current approach to regulating antibiotics

animal

Guidance # 152.

feed, as presented

The FDA concluded by stating

that "the petition can only be granted or denied when the Agency
makes a

final decision on whether to withdraw any of the drug

18

.................................'~

--------------------~_mi,.~

approvals listed in your petition."
2.

FDA's Final Response to the 2005 Petition

On November 7, 2011, during the pendency of this litigation,
the FDA issued a final response to the 2005 Petition.
127. )

The FDA stated that

"[a] 1 though we share

concern about the use of medical

(See

at

[petitioners']

important antimicrobial drugs

food-producing animals for growth promotion and feed efficiency
indications

(i.e.,

production uses),

petition."

The

FDA is denying your

FDA explained that

the

CVM's

decision

whether or not to initiate formal withdrawal proceedings for a new
animal

drug

is

"primarily

an

internal

process,

although

participation by drug sponsors and the public may be requested."
at 128.)
The FDA then explained that for "various reasons the Agency
has decided not to institute formal withdrawal proceedings at this
time

and

address

instead
the

is

issue

of

currently

pursuing

antimicrobial

other

resistance

alternatives
related

to

production use of antimicrobials in animal agriculture."
The

FDA's

decision

was

experience with contested,

based,

in

part,

on

"[t]he

formal withdrawal proceedings

The FDA continued:

19

WI

the

(rd. )

Agency's
[which]

can consume extensive periods of time and Agency resources."
at 128-29.}

to

Recognizing that the process of
reviewing safety
information for antimicrobial drugs approved before 2003,
and pursuing withdrawal proceedings in some cases, would
take many years and would impose significant resource
demands on the Agency, in June 2010, FDA proposed a
different strategy to promote the judicious use of
medically important antimicrobials in food-producing
animals in [Draft Guidance # 209]

(Id.

at

Guidance

The

129.)

#

FDA then explained the

and

209

the

FDA's

substance

"belie [f]

that

of

the

Draft
animal

pharmaceutical industry is generally responsive to the prospect of
working cooperatively with the Agency to implement the principles
recommended in [Draft Guidance # 209] ."

(Id.)

The FDA concluded:

FDA believes that the strategy set out in [Draft Guidance
# 209] is a pathway to achieving the same goals as those
advocated by [petitioners], i.e.,
judicious use of
medically-important antimicrobials. Additionally, given
the considerable amount of Agency resources that are
required to pursue withdrawal proceedings, we believe the
current proposed approach will accomplish these goals in
a more timely and resource-efficient manner than would
otherwise be the case. Moreover, this strategy does not
foreclose initiating withdrawal proceedings in the
future."

(Id. at 130.)

c.

Subsequent Agency Action

On April 13,
for

Industry #

2012,

209,

the FDA released the finalized Guidance

"The Judicious

Use

of Medically Important

Antimicrobial Drugs in Food Producing Animals."

20

i iH

(See Ex. A to the

Declaration of

Amy A.

Barcelo,

Barcelo Decl.") at 1.)
209,

the final

dated Apr.

16,

2012

("Apr.

16

As with the Draft Guidance for Industry #

dance provided "a framework for the voluntary

adoption of practices to ensure the appropriate or judicious use of
medically important antimicrobial drugs in food-producing animals."
(See id. at 3.)

The framework

ludes "phasing in such measures

as (1) limiting medically important antimicrobial drugs to uses in
food-producing animals that are considered necessary for assuring
animal

healthi

producing

and

limiting

(2)

animals

that

include

consultation."

(Id. )

" [alntimicrobial

resistance,

antimicrobial

therapies

such

in humans

to

veterinary

Guidance
and

drugs

209

#

the
is

uses

food-

oversight

acknowledged

resulting

a

in

or
that

lure

mounting public

of

health

problem of global significance[,]" and that "[t]his phenomenon is
driven by many factors including the use of antimicrobial drugs in
at 4.)

. animals."

The Guidance contained a thorough

review of the most seminal reports and peer-reviewed scientific
literature on the issue of antimicrobi

resistance.

(See

at

Guidance

for

5-17.)

On

April

Industry # 213,
Combination

13,

2012,

the

FDA

released

Draft

entitled "New Animal Drugs and New Animal Drug

Products

Administered

in

or

on

Medicated

Feed

or

Drinking Water of Food-Producing Animals: Recommendations for Drug
21

Sponsors

for

Voluntarily Aligning

[Guidance] # 209."

Product

Use

Conditions

with

(See Ex. C to the Apr. 16 Barcelo Decl. at 2.)

Draft Guidance # 213 contains information for the relevant drug
sponsors "to facilitate voluntary changes to the conditions of use
. consistent with FDA's recommendations included in [Guidance
# 209] . ,,:3

(rd.)

The FDA explained that it

recognize [d] the significance of the proposed changes and
the potential impacts such changes will have on the
animal pharmaceutical industry, animal producers, the
animal feed industry and the veterinary profession. For
this reason, FDA is currently pursuing a strategy for the
voluntary adoption of these changes
an effort to
minimize the impacts and provide for an orderly
transition.

(rd. at 7.)

The Agency requested that affected drug sponsors that

intended to make the voluntary changes inform the Agency within
three months of the publication of the final version of Guidance #
213.

(See

The

"FDA anticipates

that

sponsors

of

the

affected products should be able to complete implementation of the
Draft Guidance # 213 outlines several methods for drug
sponsors to voluntarily comply with Guidance # 209. A drug
sponsor of an affected drug may submit a supplemental new drug
application that proposes to change the marketing status of the
drug to veterinary feed directive or prescription and voluntarily
withdraw the approval for all production uses.
(See id. at 8.)
Such a supplemental application would not require additional
evidence of safety or efficacy, and in most cases the drug
sponsor would only be required to submit revised labeling.
13

rt is unknown when, if ever, the final version of Draft
Guidance # 213 will be published.
14

22

- - - - - - - - - " I I ' : ; , I 1 ! 1 1 1_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _,

changes discussed in this

t guidance within 3 years from the

date of pUblication of the f

version of this guidance.

(Id. )

/I

III. The Present Action
Plaintiffs instituted the present action,

on May 25,

2011,

prior to the FDA's issuance of a final response to either the 1999
Petition or

the

2005

Petition.

In

the

Compla

Plaintiffs

claimed that the FDA's failure to issue a final response to the
Citizen Petitions constituted an agency action unreasonably delayed
in violation of the APA and the FDA's implementing regulations.
~

(See Compl.
7,

the

2011, but the claim regarding
Petitions

Compl.
all

Plaintiffs filed an Amended Compla

98.)

/I)

~

remained

101.)

claims

P

the

on July

FDA's failure to respond to

same.

Amended

Compl.

("Am.

intiffs filed a motion for summary judgment on

on October

6,

2011.

As

discussed above,

the

FDA

provided final responses to both the 1999 Petition and the 2005
Petition

on

November

7,

2011.

Rec.

at

71,

127. )

Consequently, on January 6, 2012, Plaintiffs withdrew the
regarding the FDA's

claim

lure to respond to the Petitions as moot.
31,

However, on

2012,

this Court granted

iffs

leave to file a supplemental complaint, which Plaintiffs fil
February I, 2012.
claim for relief

on

The Supplemental Complaint added an additional
("

rd claim for reI

fll),

alleging that the

FDA's final responses denying the 1999 and 2005 Citizen Petit
23

.............................................

-------------------------------q~,~hm,

~

were "arbitrary, capricious, an abuse of discret
not

accordance with law

360b, and the APA, 5 U.S.C.

! or otherwise

violation of the [FDCA], 21 U.S.C.
706(2)."

§

(Supplemental Compl.

~

§

38.)

Presently before the Court are the parties' cross motions for
summary judgment on Plaintiffs' third claim for relief.
DISCUSSION

I.

Legal Standard
A.

Summary Judgment

A motion for summary judgment may not be granted unless the
Court determines that there is no genuine issue of material fact to
be tried,
warrant

that the facts as to which there is no such issue

judgment for

Celotex Corp. v.
2552-53 (1986)

i

the moving party as a

Catrett,

477 U.S.

317,

matter

law.

See

322-23, 106 S. Ct. 2548,

Patterson v. Cnty. of Oneida! 375 F.3d 206, 219 (2d

Cir. 2004);
Cir. 2003}.

burden of demonstrating the absence of any genuine

dispute as to a material fact rests upon the party seeking summary
judgment, see

~~~==~~-=~~~~~~-=-=~,

S. Ct. 1598, 1608 (1970), but once a

398 U.S. 144, 157, 90

ly supported motion for

summary judgment

been made, the burden shifts to the nonmoving

party to make

ficient

a

showing

to establish the

essent

elements of that party's case on which it bears the burden of proof
at trial. See Hayut v. State Univ. of N.Y., 352 F.3d 733, 743
24

------------------....,i"'T!l,__________________ij}f;3;l

(2d

Cir. 2003}
Where,

(citing Celotex, 477 U.S. at 322, 106 S. Ct. at 2552).

as

judgment,

a

court

considers

cross-motions

for

summary

the court applies the same legal principles and "must

evaluate each party's motion on its own merits, taking care in each
instance to draw all reasonable inferences against the party whose
motion is under consideration."
~=~,

Make the Road by Walking, Inc. v.

378 F.3d 133, 142 (2d Cir. 2004)

Here,

(citations omitted)

the parties do not dispute the essential facts.

only issue before the Court is

The

legal conclusion resulting from

those facts.
B.

Subject Matter Jurisdiction

Defendants

argue

that

this

Court

jurisdiction over the FDA's denial of
Petitions.

Specifical

lacks

subject

matter

1999 and 2005 Citizen

, Defendants contend that the FDA's denial

of the Petitions was an action "committed to agency discretion by
law" and thus outside the scope of judicial review pursuant to
APA.

5 U. S . C.
1.

§

701 (a) (2)

Legal Standard

Under FDA regulations, the denial of a citizen petition is a
final agency action subject to judicial review.
10.45(d}

The

Administrate

Procedure

Act

See 21 C.F.R.

( "APA" ),

therefore,

governs judicial review of the denial of the Petitions.
U.S.C.

§§

701-06.

Although the APA embodies a "basic
25

§

5

sumption

of judicial review," Reno v. Catholic Soc. Servs., Inc., 509 U.S.
43, 57, 113 S. Ct. 2485, 2495

(1993), by its terms, the APA does

not apply if an "agency action

committed to agency discretion by

law."

5 U.S.C.

§

701(a) (2).

"very

narrow"

and

This exception to judicial review is

"applicable

in

those

rare

instances

where

statutes are drawn in such broad terms that in a given case there
is no law to apply."

Citizens to Preserve Overton Park, Inc.

Volpe ("

91 S. Ct. 814,

820 21

(internal quotation marks and citations omitted);

(1971)

accord

Drake v.

), 401 U.S. 402, 410,

V.

FAA,

291 F.3d 59,

70

(D.C.

Cir.

2002).

Accordingly,

judicial review is precluded "if the statute is drawn so that a
court would have no meaningful standard against which to judge the
agency's exercise of discretion.
830,

105 S.

("If

no

Ct. 1649,

such

meaningful

judic

judic

1655

ff

Heckler v. Chaney, 470 U.S. 821,
Drake,

(1985) ;

ly manageable

standards

review is impossible,

291 F.3d at 70

are

discernable,

and agency action is

lded from the scrutiny of the courts. 1/)

(internal quotation

In such cases,

"the courts have no

marks and citations omitted) .

norms pursuant to which to evaluate the challenged act
and thus no concrete limitations to impose on the agency's exerc
of discretion.

ff

Drake, 291 F.3d at 70.

"In determining whether a matter has been committed solely to
agency discretion,

[a court] must consider both the nature of the
26

administrative action at issue and the language and structure of
the

statute

that

supplies

the

applicable

legal

standards

for

reviewing that action."

Drake, 291 F.3d at 70 (internal citation

omitted) .

actions

Enforcement

are

presumptively

committed

to

agency discretion by law and are therefore outside the bounds of
judicial review.

See Chaney, 470 U.S. at 832, 105 S. Ct. at 1656

(" [A]n agency's decision not to take enforcement action should be
presumed

immune

701 (a) (2) .").

from

judicial

review

under

[5

U.S.C.]

§

However, this presumption of unreviewability "may be

rebutted where the substantive law has provided guidelines for the
agency to follow in exercising its enforcement powers[,]" or where
"the agency has consciously and expressly adopted a general policy
that is so extreme as to amount to an abdication of its statutory
at 833 & 833 n.

responsibilities."

4, 105 S. Ct. at 1656 &

1656 n. 4 (internal quotation marks and citations omitted)

i

accord

Jerome Stevens Pharm. ( Inc. v. FDA, 402 F.3d 1249, 1257 (D.C. Cir.
2005) .
2.

a.

Enforcement Action

Although Defendants

claim

that

the

decision

to

institute

formal withdrawal proceedings is an enforcement decision, the Court
disagrees.

First,

the provisions of the FDCA at issue in the

present case are the substantive regulatory provisions.
27

See 21

U.S.C.

360b.

§

provisions

at

In
issue

which
were

so

enforcement

involved the

the

There,

provisions.

FDCA,

the

Supreme Court rejected a challenge to the FDA's denial of a citizen
pet

ion requesting that the Agency take a number of enforcement

actions,

including seizing drugs,

adding warning labels to the

drugs, and prosecuting all individuals in the chain of distribution
who knowingly distributed the drugs

for

the use

Chaney, 470 U.S. at 824, 105 S. Ct. at 1651 52.

in question.

These actions are

authorized pursuant to provisions contained within Subchapter III
of the FDCA, which is ent

led "Prohibited Acts and Penalties" and

governs enforcement proceedings. 1

In contrast, here,

the action

requested by Plaintiffs - withdrawal of approval - would be taken
pursuant to a provision contained in Subchapter V of the FDCA,
which is entitled "Drugs and Devices" and governs the regulation of
human and veterinary drugs.
substantive provisions of

Because the present case involves the
the FDCA,

which address

the Agency's

15 Subchapter III contains one provision relating to the
withdrawal of approval of abbreviated new drug applications.
21 U.S.C. § 335c(a) (1) (requiring the Secretary to "withdraw
approval of an abbreviated drug application if the Secretary
finds that the approval was obtained, expedited, or otherwise
ilitated through bribery, payment of an illegal gratuity, or
fraud or material false statement.
."). This provision is
not at issue in the current dispute, as the Citizen Petitions
requested the FDA to withdraw approval of the relevant
NADAs/ANADAs, pursuant to 21 U.S.C. § 360b(e) (1) (B), on the
grounds that the drugs were not shown to be safe.

28

affirmative obligations to ensure the safety of drugs approved by
the Agency, Chaney is not controlling.
Defendants maintain that the distinction between enforcement
and substance

is not dispositive.

They cite several cases

support the proposition that

to

clude judicial review of

agency actions taken pursuant to substantive statutory provisions.
See Jerome Stevens Pharm., 402 F.3d at 1258;
Collins,

359 F.3d 156,

165-66

Heckler,

779 F.2d 683,

685

(2d cir.

(D.C.

2004); Schering Corp. v.
1985).

these cases clearly supports this proposition.

However,

none of

In

which involved a challenge to the Nuclear Regulatory Commission's
denial of a request to require additional safety measures prior to
renewing a nuclear power plant's license, there was no dispute that
the requested action was an enforcement action.
359 F.3d at 166 n. 11.16

Riverkeeper,

Although both Riverkeeper and the action

presently before the Court involve substantive statutory provisions
regarding licensing,

the

court's failure to analyze

whether the action at issue qualified as enforcement renders it
irrelevant.

The plaintiff
Riverkeeper first raised the argument
that the requested action was not an enforcement action in its
reply
f.
Riverkeeper, 359 F.3d at 166 n. 11.
Consequently, the court declined to review the issue and treated
the action as enforcement without analysis.
See
29

The

other

cases

cited

by

Defendants

distinguishable from the present action.

are

similarly

In Schering, the court

declined to review a challenge to the FDA's decision to enter a
settlement agreement

with a

drug manufacturer whereby the

agreed not to "initiate any enforcement litigation against

FDA
[the

manufacturer]" until the manufacturer had filed a citizen petition
and received a decision on whether the manufacturer's product was
a new animal drug.
quotation

marks

See Schering Corp., 779 F.2d at 685 (internal

and

citation

omitted).

Schering,

therefore,

involved a challenge to the FDA's explicit statement that it would
not enforce a possible violation of the FDCA for a set period of
time,

which

clearly

unreviewability.

falls

Last

under

the

Chaney

presumption

of

, i n Jerome Stevens, the court determined

that the FDA's decision to extend the deadline for the submission
of new drug applications for a particular drug was a dec
to enforce and immune from judicial review.

deadline,

the

FDA

See Jerome Stevens,

The court reasoned that,

402 F.3d at 1257-58.
was

announcing

its

ion not

by extending the

intention

not

to

bring

enforcement actions against manufacturers selling the drug without
an approved application.
Here,

however,

the

id.
relationship

between

a

withdrawal

proceeding and subsequent enforcement actions is not as clear.
During the pendency of a withdrawal proceeding, a drug applicant
30

~h

i 'f Ii

may still manufacture and sell the drug at issue without
liability
proceedings

pursuant
will

to

not

the

statute.

Furthermore,

necessarily result

in

the

ing any
withdrawal

issuance

of

a

withdrawal order, as a withdrawal order can only be issued after
the drug applicant has an opportunity for an evidentiary hearing.
See 21 U.S.C.

§

360b(e) (1).

Consequently, the Agency's decision

whether to initiate withdrawal proceedings for a part
the

first

instance has

little

if

drug in

any bearing on the Agency's

enforcement decisions regarding that drug.
The process of withdrawing approval of a new animal drug is
more

analogous

enforcement

to

informal

actions. 17

First,

rulemaking
although

than
the

to
FDA

traditional
may

regulate

approved drugs through regulations passed pursuant to notice and
comment rulemaking,

the Agency has chosen to utilize withdrawal

proceedings as the primary means of formally regulating approved
drugs.

18

Second, withdrawal

eedings are undertaken as a result

17 Judicial review is
ly available when a plaintiff
brings
challenging an agency's denial of a citizen petition
request
that the agency
iate informal rulemaking. See
Massachusetts v. EPA, 549 U.S. 497, 527, 127 S. Ct. 1438, 1459
(2007) ("Refusals to promulgate rules are.
. susceptible to
judic
review, though such review is extremely limited and
highly deferential.") (internal quotation marks and citations
omitted) .
18 At oral argument,
Defendants conceded that the Agency has
not utilized rulemaking to regulate the use of approved drugs,
other than through the publication of guidance documents for
indust
(See Transcript, dated May 10, 2012, at 22.)

31

of a finding by the FDA regarding the drug's safety or efficacy,
and are not premised on

violation of any law or regulation. 1

See 21 U.S.C.

(describing the grounds for mandatory

360b(e) (1)

§

withdrawal of approval of a new animal drug application).

In

contrast, enforcement proceedings are traditionally undertaken upon
a finding that an entity has violated an existing regulation or
law.

Third,

withdrawal

proceedings

aspects making them more akin to

have

several

legislat

tional informal rulemaking.

For example, withdrawal of approval has future effect.
FDA has withdrawn approval of a NADA,
being

sold

or

marketed

under

Once the

it prevents that drug from

the

FDCA,

and

it

prevents

manufacturers of generic drugs from receiving approval to market
versions of such drugs.
In

Massachusetts

v.

Environmental

Supreme Court listed several factors

Agency,

the

distinguish enforcement

549 U.S.

proceedings from rulemaking.
1438, 1459 (2007).

Protection

497,

527,

127 S. Ct.

The Court explained:

In contrast to nonenforcement decis
, agency refusals
to
tiate rulemaking are less frequent, more apt to

Of course, withdrawal proceedings may be instituted for
other reasons, including that the initial drug application
contained untrue statements of material fact.
21 U.S.C. §
360b(e) (1) (El i
§ 360b(e) (2)
(explaining the grounds for which
the Secre
withdraw approval of a new animal drug
application) .
32

as opposed to factual analysis, and subject
formalities, including a public explanation.
They moreover arise out of denials of petitions for
rulemaking which (at least in the circumstances here) the
affected party had an undoubted procedural right to file
in the f
instance.

rd.

at

527,

citations

127

S.

Ct.

omitted).

at

1459

Although

quotation marks

the

FDA's

decision

to

and

withdraw

approval of a new animal drug involves a factual analysis, that is
not its exclusive basis; and, in
rulemaking proceeding.
subject

to

(requiring

formal
an

1 other aspects it is akin to a

Withdrawal proceedings are infrequent and

proceedings.

opportunity

for

issuance of a withdrawal order).

21
a

public

U.S.C.
hearing

12.120.

And

here,

as

360b{e) (1)
to

the

Any withdrawal order must contain

an explanation of the findings supporting the order.
§

§

21 C.F.R.

in

Protection Agency, the FDA's decision not to init

withdrawal of

approval of the relevant new animal drugs was a result of the FDA's
denial of a petition that the petitioners had a right to bring.
21 C. F. R.

§

10.30 (b) (2)

(explaining the requirements for the

submission of a citizen petition and stating that a petition may
request that the
Finally,

the

"issue, amend, or revoke an order . . . n).
FDA's

own discussion of

its decision on the

Petitions strongly paints this action as regulatory rather than
enforcement.

The FDA received more than 38,000 comments on the
33

1999

Petition,

and

"the

comments

and other

relevant

data and

information needed to be evaluated by the Agency before action
would be taken.

(See

11

Rec.

at

71.)

In its

second tentative

response to the 1999 Petition, the Agency explained that it would
"issue a final response [the 1999 Petition] upon completion of [the
Agency's)

analysis

of

the

comments

received

on

[the

citizen

petition)! the Framework Document, numerous consultations, and the
resolution of the scientific, legal, and policy issues."
66. )

(Rec. at

This description of the process of reviewing the Citizen

Petitions
rulemaking.

closely

mirrors

Furthermore,

the

process

of

notice-and-comment

the Agency rested its denial

of

the

Petitions! in part, on the Agency's decision to pursue a different
regulatory strategy.

The Agency explained that it had "proposed a

different

strategy

important

antimicrobials

(See Rec. at 73,

to

129.)

promote
in

the

judicious

food-producing

use

animals

of

medically

"

This statement suggests that the Agency

considers withdrawal proceedings one regulatory strategy and the
vOluntary program embodied in Guidance #209 another regulatory
strategy.
For all the above reasons, the Court finds that initiating the
withdrawal of approval of a new animal drug is not an enforcement

34

action.20
b.

Law to Apply

Even if the Court were to find that the withdrawal of approval
of a new animal drug is an enforcement action,

the FDCA provides

sufficient "guidelines for the agency to follow in exercising its
enforcement powers" to rebut the presumption of unreviewability.
Chaney, 470 U.S. at 833, 105 S. Ct. at 1656.
The FDA is charged with regulating drugs sold in interstate

In any event, if the Court were to find that withdrawal
of approval is an enforcement action, the FDA's denial of the
Petitions announced a general Agency policy of not pursuing
withdrawal proceedings for the subtherapeutic use of antibiotics
in food-producing animals.
Unlike a specif
decision not to
enforce, an agency's general policy regarding enforcement is
subject to judicial review.
Crowley Caribbean Transport,
Inc. v. Pena, 37 F.3d 671, 676 (D.C. Cir. 1994) ("[A]n agency's
statement of a general enforcement pOlicy may be reviewable for
legal sufficiency where the agency has expressed the policy .
in some form of universal policy statement.") (internal citations
omitted) (emphasis in original) i Roane v. Holder, 607 F. Supp.2d
216, 226-27 (D.D.C. 2009) (same).
In Crowley, the court
explained that general enforcement policies are subject to
judicial review because they "are abstracted from the particular
combinations of facts the agency would encounter
individual
enforcement proceedings" and "will generally present a clearer
(and more easily reviewable) statement of its reasons for acting
when formally articulating a broadly applicable enforcement
policy.
" Crowley, 37 F.3d at 677.
Here, the Agency's
denials did not consist of a drug-by-drug analysis and decision
not to enforcei rather,
the denial letters, the Agency
announced a policy for the regulation of subtherapeut
use of
antibiotics in food-producing animals whereby the Agency would
not initiate formal withdrawal proceedings and would instead rely
on a voluntary program.
Such a broad statement of policy is
subject to judicial review.
35

commerce.

21 U.S.C. § 393(b).

Pursuant to the FDCA, any new

animal drug shall be deemed unsafe and "adulterated" unless it is
subject to an approved or conditionally approved NADA/ANADA.
21 U.S.C. § 360b(a).

See

The FDA is required to approve a NADA/ANADA

unless it finds that grounds for non-approval exist, which include
a finding that the drug is not safe.

§

Once the FDA approves a NADA/ANADA,
applicant

have

required to

continuing

360b(c) (1)

&

(d) (1) (B).

both the FDA and the drug

obligations.

Drug

appl

are

"establish and maintain indexed and complete files

containing full records of

1 information pertinent to safety or

effectiveness of a new animal drug that has not been previously
submitted as part of the NADA or ANADA./l

21 C.F.R.

§

514.80(a) (1).

Furthermore, drug applicants "must submi t reports of data, studies,
and other information concerning experience with new animal drugs
to the

[FDA]

for each approved NADA and ANADA .

514.80(a) (2).

"

§

The regulations contemplate third parties producing

data relevant to this analysis and require such third parties to
"submit data, studies, and other information concerning experience
with new animal drugs to the appropriate applicant . .
turn,

must

report

the

nonapplicant' s

information to the FDA."
reports

required

in

[21

data,

studies

[who], in
and

other

The "FDA reviews the records and
C.F.R.

determination under [21 U.S.C.

§

§

514.80]

to

facilitate

a

360b(e)] as to whether there may

36

be grounds for suspending or withdrawing approval of the NADA or
ANADA.

Id.

II

514.80 (a) (3).

§

Secretary shall,

Section 360b (e) (1) states that" [t] he

ter due notice and opportunity for hearing to

the applicant, issue an order withdrawing approval of [a new animal
drug application] if the Secretary finds

. that new evidence .

shows that such drug is not shown to be safe
U.S.C.

" 21

360b(e) (1) (B)

§

The FDCA and accompanying regulations require the FDA, as part
of its regulatory authority, to monitor and evaluate data regarding
approved new animal drugs and institute withdrawal proceedings if
the data shows that the drugs are no longer shown to be safe.
Although § 360b(e) (1) grants the Secretary the discretion to make
an initial finding whether a drug is shown to be safe or not, the
substance

and

structure

discretion in making
C.F.R.

§

regarding

514.80

makes

withdrawal,

that

of

the

initial

clear
the

Agency

§

393(b),

which

cabin

decision.

that

evidence of the drug's safety.
U.S.C.

FDCA

to

Secretary's

Specifically,

in making
is

the

initial

review

the

21

decisions
scientific

This finding is buttressed by 21

requires

the

FDA

to

"promptly

and

efficiently review [] clinical research" and ensure that "veterinary
drugs are safe and effective[.J"
The Court is satisfied that

§

regulations,

the

which

guide

21 U.S.C.

393(b),

§

393(bl (1)

&

(2) (B).

360b, and the accompanying

Agency's
37

§

approval

and

continued

monitoring of new animal drugs, provide sufficient guidelines to
allow the Court to review the action challenged in the present
case.
Accordingly, the Court finds that there are standards and law
to apply and that the FDA's denials of the 1999 and 2005 Citizen
Petitions are subject to judicial review. z:
C.

The Administrative Procedure Act

The APA provides
agency's findings,

that

a

district

court may

set

aside

an

conclusions of law, or action only if they are

"arbitrary, capricious, an abuse of discretion, or otherwise not in
accordance with law."
action,

[a]

the agency.

5 U.S.C.

§

706 (2) (A).

"In reviewing agency

[c] ourt may not 'substitute its judgment for that of
'11

Natural Res. Def. Council v. EPA, 658 F.3d 200, 215

21 Several other courts have found that FDA decisions
regarding the regulation of approved animal drugs are subject to
judicial review.
See A.L. Pharma, Inc. V. Shalala, 62 F.3d 1484,
1488-89 (D.C. Cir. 1995) (reviewing the FDA's refusal to withdraw
approval of a new animal drug application after the plaintiff
filed a citizen petition with the FDA alleging that the relevant
drug application relied on improperly obtained information and
should not have been approved according to the FDA's own
regulations) i Barnes v. Shalala, 865 F. Supp. 550, 558 (W.D.
Wisc. 1994) (holding that the FDA's decision not to require
labeling of milk products containing recombinant bovine
somatotropin (rbST) was subject to judicial review because the
plaintiffs were not requesting "the FDA to investigate an
unapproved use of [an approved drug]
and instead were asking
"only that, as part of the FDA's reconsideration of the safety
and effectiveness of rbST, the agency consider whether the
approved use of the drug requires labeling") .
II

38

(2d Cir. 2011)
824).

Nevertheless, a reviewing court' s "inquiry must be searching

and careful.
549,

(quoting Overton Park, 401 U.S. at 416, 91 S, Ct. at

555

Natural Res. Def. Council,

/I

(2d Cir.

omitted) .

An

2009)

agency

Inc. v.

FAA,

564 F.3d

(internal quotation marks and citations
decision

may

be

deemed

arbitrary

and

capricious "if the agency has relied on factors which Congress has
not

intended

it

to

consider,

entirely

important aspect of the problem,

led

to

consider

an

offered an explanation for its

decision that runs counter to the evidence before the agency, or is
so implausible that it could not be ascribed to a difference in
view or the product of agency expertise.

/I

Ass' n of U. S.,

Auto,

Farm") ,

Ind.

v.

State Farm Mut.

Motor Vehicle Mfrs.
Ins.

Co.

("State

463 U.S. 29, 43, 103 S. Ct. 2856, 2867 (1983); accord Yale­

New Haven HOSp. v. Leavitt, 470 F.3d 71, 79 (2d

r. 2006).

While this standard of review is deferential, courts "do not
hear cases merely to rubber stamp agency actions.
role

would

responsibili

be

'tantamount

to

abdicating

Pharma,

judiciary's

Inc. v.

Shalala,

755

II

Natural

(D.C.

Cir.

2000)

62 F.3d 1484,

1491

(D.C.

Islander East Pipeline Co., LLC v. McCarthy,

Cir. 1995));
525 F. 3d 141,

the

under the Administrative Procedure Act.'
209 F.3d 747,

(quoting A.L.

To play that

151

(2d Cir.

2008)

("This is not to suggest that

judicial review of agency action is merely perfunctory.
39

To the

contrary,

within the prescribed narrow sphere,

must be searching and careful.")
citations omitted).

judicial inquiry

(internal quotation marks and

To be upheld upon judicial review, the agency

must have articulated "a rational connection between the
found and the choice made."
Cir. 1996)
D.

Henley v.

FDA,

facts

77 F.3d 616, 620

(2d

(quotation marks omitted)
Application

Here, the 1999 and 2005 Citizen Petitions requested that the
FDA withdraw approval
antibiotics

in

for

certain uses

food-producing

animals.

of

medically important

The

FDA

issued

final

responses to the 1999 and 2005 Citizen Petitions on November 7,
2011,

denying

"shar [ing]

the

actions

[peti tioners' ]

requested.

concerns

about

Specifically,
the

use

of

while

medically

important antimicrobial drugs in food producing animals for growth
promotion and feed efficiency indications [,]" (Tr. at 71, 127), the
FDA explained that it had decided not to initiate formal withdrawal
proceedings for the medically-important antibiotics implicated in
the Petitions, and, instead, was pursuing a voluntary strategy to
address antibiotic resistance related to the use of the antibiotics
in food-producing animals.
final responses,
contested,

(See Rec.

at 73,

129-30.)

In both

the Agency explained that its "experience with

formal withdrawal proceedings is that the process can

consume extensive periods of time and Agency resources."
40

at

73,

128 29.)

The

Agency

continued:

"Recognizing

that

the

process of reviewing safety information for antimicrobial drugs
approved before 2003, and pursuing withdrawal proceedings in some
cases, would take many

and would impose significant resource

demands on the Agency,
strategy

to

promote

antimicrobials
129. )

in June

the

2010,

judic

FDA proposed a

use

of

medically

food-producing animals

"

different
important
id. at 73,

The Agency went on to describe Draft Guidance # 209, which

provides non-binding industry guidance for the judicious use of
medically-important antibiotics in food-producing animals.
Essentially, the Agency presented two grounds for denying the
Petitions.

First, the Agency cited the time and expense required

to evaluate individual drug safety and to hold formal withdrawal
proceedings if necessary.

Second,

the Agency emphasized that it

had adopted non-binding voluntary measures to promote the judicious
use of antibiotics in food-producing animals,

which

believed

would achieve the same result as formal withdrawal proceedings.
Neither of these grounds provides a reasoned justification for the
Agency's refusal to initiate withdrawal proceedings.
In responding to a citizen petition, an agency's "reasons for
action or inaction must

conform

to

the authorizing statute."

Massachusetts v. EPA, 549 U.S. at 533, 127 S. Ct. at 1462.

Here,

the FDCA provides that the Agency's decision whether to initiate
41

formal withdrawal proceedings must be based on an evaluation of the
scientific

evidence

360b(e) (1) (b) .

of

a

drug's

safety.

See

21

U.S.C.

§

If the evidence demonstrates that a drug is not

shown to be safe,

the Agency must rescind approval of that drug

through formal withdrawal proceedings.

See

Williamson Tobacco Corp., 529 U.S. 120, 133, 120 S. Ct. 1291, 1301
(2000)

("Viewing the FDCA as a whole, it is evident that one of the

Act's core objectives is to ensure that any product regulated by
the FDA is \ safe' and \ effective' for its intended use. 1/)
citations omitted)

The statute contains no language indicating

that the costs of a withdrawal proceeding 1

(internal

f or to industry -

either to the Agency

are to be taken into account when making

the decision whether to initiate withdrawal proceedings.
in both approving
whether withdrawal

tial

an

drug

Rather,

application and determining

appropriate, the inquiry focuses on whether

the drug is safe and effective.

21 U.S.C.

§

360b(b) (1) (A)

(requiring a new animal drug application sponsor to submit "full
reports of investigations which have been made to show whether or
not such drug is safe and ef fecti ve for use");
(explaining

for

the Agency

do

"reports

groundS

not

include

to

deny a

adequate

tests

id.

§

NADA,

3 60b (d) (1)
including

by all

methods

reasonably applicable to show whether or not such drug is safe for
use .

/I

or "the results of such tests show that such drug is
42

unsafe for use .
. ") i

. or do not show that such drug is safe for use
360b (e) (1) (B)

§

(requiring the Agency to withdraw

approval of a NADA/ANADA if the Agency finds that a drug is "not
shown to be safe").
In

the

instant

case,

Petitions on their merits.

the

Agency

failed

to

address

the

The Agency did not evaluate the science

presented in the Petitions or assess the safety of the relevant
Although the Administrative Record for the 1999 and 2005

drugs.

Citizen Petitions is more than three thousand pages in length and
contains numerous scientific studies of the risks of antibiotic
resistance from the use of antibiotics in food-producing animals,
the Agency did not address or even mention the scientific evidence
in its responses.

Further,

in

its

tentative responses to the

Citizen Petitions, the Agency stated that" [f]or legal, scientific
and resource reasons, withdrawal actions for the petitioned drugs
need

to

be

considered

on

a

drug

by

drug

basis.

Data

and

information will need to be reviewed and analyzed for each drug.
Thus the petitions can only be granted or denied on a drug by drug
basis as reviews are completed and resources permit.
52, 124.)

II

Rec. at

However, the Agency issued its final responses, denying

the Petitions,

without presenting any evidence -

letters or in the Record -

in the denial

that these drug by drug analyses had

been completed or ever undertaken.
43

There is no evidence in the

Record that the Agency performed any risk or safety assessments of
the petitioned drugs at all.
the drugs'

The Agency simply refused to evaluate

safety on the grounds that if withdrawal proceedings

were required they would "take many years" and "impose significant
resource demands.

1122

(rd. at 73, 129.)

Denying the Petitions on the grounds that it would be too time
consuming and resource-intensive to evaluate each individual drug's
safety, and withdraw approval if a drug was not shown to be safe,

22

not addressing the scientific evidence,

the FDA failed

to adequately explain why some classes of antibiotics are sUbject
to withdrawal proceedings and not others.
For example, in 1977,
the Agency issued init
findings that penicillin and
tetracycline were not shown to be safe for subtherapeutic use in
food-producing animals, and, pursuant to 21 U.S.C. § 360b(e) (1),
published notices of an opportunity for hearings in the Federal
Register.
See Penicillin Notice, 42 Fed. Reg. at 43,774;
Tetracycline Notice, 42 Fed. Reg. at 56,264. Although these
notices were still pending when the Agency denied the Petitions,
the Agency did not address - in either the denial letters or the
Record
why the evidence demonstrating that penicillin and
tetracycline were not shown to be safe did not apply to the other
classes of antibiotics implicated in the Petitions. Similarly,
in denying the 2005 Petition, the Agency failed to adequately
explain why the petitioned antibiotics, which would be classified
as "high risk" or "medium risk" under Guidance # 152 and
therefore would not receive Agency approval if the subject of a
new NADA/ANADA, were not subject to withdrawal proceedings. The
Agency fails to provide a reasoned explanation why these drugs
should remain on the market, other than the time and expense
involved in withdrawing approval. While courts will defer to an
agency's scientific expertise, here, the Agency has presented no
explanation for its decision to treat penicillin and tetracycline
differently than the other classes of antibiotics implicated in
the Petitions and no reason why antibiotics that would no longer
receive initial approval can nevertheless remain on the market.
44

1S

to

arbitrary and capricious.
consider

the

overall purpose
health and,

The Agency did not discuss or appear

controlling

statute's

governing

criteria

and

whether the drugs at issue pose a threat to human

if so,

the obligation to withdraw approval for such
See Massachusetts v. EPA,

health-threatening drugs.
535, 127 S. Ct. at 1463

549 U.S. at

(holding that an agency "must ground its

reasons for action or inaction in the statute"); State Farm, 463
U.S. at 43, 103 S. Ct. at 2867 ("Normally, an agency rule would be
arbitrary and capricious if the agency has relied on factors which
Congress has not intended it to consider
withdrawing approval
sufficient

may be

justification,

.•

The fact that

• ff).

costly or time-consuming

under

the

FDCA,

for

the

is not a
Agency

to

abdicate its duty to ensure that the use of animal drugs is safe
and effective.

Congress has explicitly provided the mechanism to

be employed when a drug is found not to be safe.
FDA is

refusing to

follow

the

In effect, the

statutory mandate of withdrawal

proceedings on the ground that such proceedings are not effective
because they take too 10ng. 23

Yet, the Petitions at issue have been

pending for thirteen and seven years, respectively.

The position

that instituting withdrawal proceedings - what the statute mandates

23
One can only wonder what conceding the absence of an
effective regulatory mechanism signals to the industry which the
FDA is obligated to regulate.

45

is too time consuming is both ironic and arbitrary.
Agency addressed the Petitions

in a

timely fashion,

Had the
withdrawal

proceedings could have been commenced and completed by now.

24

Moreover, the Agency failed to address the Citizen Petitions'
request that the Agency withdraw approval of the use of medically
important antibiotics in food producing animals for the purpose of
disease prevention.

In the denial letters, the Agency stated that

it shared the Petitioners'

"concern about the use of medically

important antimicrobial drugs in food-producing animals for growth
promotion and feed efficiency indications (i.e., production uses).

"

(Rec. at 71, 127.)

However, the Agency made no mention of

24 It is not clear why the withdrawal proceedings must be on
a drug-by-drug basis, with individualized research and
conclusions as to each drug.
There is no evidence that the
scientific studies undertaken by various groups and government
bodies draw different conclusions for different antibiotics.
Indeed, the FDA appears to accept that all of the classes of
antibiotics at issue pose a similar threat, as its proposed
voluntary approach makes no distinction. At most, it appears
that the Agency would have to issue eleven different notices of
an opportunity for a hearing for the eleven different classes of
antibiotics implicated in the Petitions.
For example, in 1977,
the Agency issued one notice pertaining to penicillin
NADAs/ANADAs, see Penicillin Notice, 42 Fed. Reg. at 43,774, and
one notice pertaining to tetracycline NADAs/ANADAs, see
Tetracycline Notice, 42 Fed. Reg. at 56,264, despite the fact
that each notice applied to multiple drug products. Moreover,
after receiving requests for hearings on the 1977 notices, the
Agency indicated that it would hold a single public evidentiary
hearing on both the proposed penicillin and tetracycline
withdrawals.
See Penicillin and Tetracycline in Animal Feeds
Hearing, 43 Fed. Reg. 53,827, 53,827 (Nov. 17, 1978).

46

iN!

tiR _ _

use of medically-important antibiotics
in animals.

disease prevention

The Agency stated that it did not consider production

uses a judicious use of medically-important antibiotics and planned
to phase out such uses through the voluntary guidance program.
(See

at

72-73,

129.)

The voluntary guidance program also

requests that other uses of medically- important antibiotics
animals,

in

including use of antibiotics for disease prevention, be

available only through a veterinary directive.

(See

The

Agency did not respond to the Petitioner's claims that the use of
the indicated antibiotics for general disease prevention was not
shown to be safe,

and did not provide any explanation for its

decision

to

the

purpose.

This failure to explain the Agency's decision-making is

allow

arbitrary and capricious.

25

continued use

of

~~=-~~,

these

drugs

for

that

463 U.S. at 43, 103 S.

The Agency did address this issue in Guidance # 209.

Agency explained:
Some may have concerns that the use of medically
important antimicrobial drugs in food-producing animals
for disease prevention purposes is not an appropriate
or judicious use.
However, FDA believes that some
indications for prevention use are neces
and
judicious as long as such use includes professional
veterinary involvement.
When determining the
appropriateness of a prevention use, veterinarians
consider several important factors such as determining
the medical rationale for such use and that such use is
appropriately targeted at a specific etiologic agent
and appropriately timed relative to the disease.
47

---------­

......................................................................................

~

Ct.

at

2866

(" [T] he agency must examine

articulate a satis

the

re

data and

tory explanation for its action including a

rational connection between the facts found and the choice made.")
rnal quotation marks and citations omitted)
Plaintiffs contend, with some justification, that the Agency's
refusal to evaluate the science was motivated in part by a desire
to avoid the statutory requirement of initiating formal withdrawal
proceedings for drugs not shown to be safe.

Nevertheless,

the

Agency has all but made a finding that the subtherapeutic use of
antibiotics in food producing animals has not been shown to be
safe.

In the course of this litigation,

the Agency has conceded

that "the phenomenon of antimicrobial resistance exists,
antimicrobial resistance poses a

[that]

threat to public health,

[and

that] the overuse of antimicrobial drugs in food-producing animals
can contribute to the development of antimicrobial resistance."
(See Memorandum of Law in Support of the Government's Motion for
Summary Judgment on Plaintiff's First Supplemental Complaint at 2. )
The

Agency

has

also

that

stated

recommendations provided by .
based on

s

review

I

believes

it

"has

reviewed

the

various published reports and,
the

overall

weight

of

evidence

(Ex. A to the Apr. 16, 2012 Barcelo Decl. at 21.)
This
explanation still fails to address the science indicating that
such use could pose a risk to human health.
48

available to date supports the conclusion that using medically
important antimicrobial drugs
interest
at 179.)

production purposes is not in

protecting and promot

the public health."

These statements, while not the equiva

that

Rec.

of a finding

rs a withdrawal proceeding under the FDCA, indicate that

the Agency recognizes that these drugs pose a
serious risk)

However,

to human health.

statutorily prescribed action

sk (possibly a very

instead of taking the

making a finding that the drugs are

not shown to be safe and initiating withdrawal proceedings - the
Agency has pursued a course of action not foreseen by Congress.
Of course, nothing prevents the Agency from seek

voluntary

coopera tion from the drug industry,

in tandem with a notice of

intent

it

to

withdraw approval.

Had

done

so

years

ago,

and

achieved success, there would be no need for withdrawal proceedings
But in the instant case, the Agency was

now.

Citizen petitions,

seven and thirteen years

sented with two
ago,

respectively,

alerting the Agency to the human health risks associated with the
subtherapeut

use of antibiotics in food-producing animals.

In

an eleventh hour response, the Agency pointed to a guidance program
that encourages industry to use these drugs "judiciously," with no
hard evidence that the drug sponsors have agreed or will agreed to

The Agency has been aware of the science indicating a
human health risk since the early 1970s.
26

49

proposed measures.

By refusing to make findings as to the

drugs' safety - or provide a statutorily based reason for refusing
to make such findings -

the Agency avoided the Congressionally

mandated scheme for address

drugs not shown to be

The

Agency may not substitute proposed voluntary measures,

such as

those embodied in Guidance # 209, for the measures mandated by the
statute.

Natural Res. Def. Council, Inc. v. EPA, 595 F. Supp.

1255, 1261 (S.D.N.Y. 1984)

("It is not an agency's prerogat

to

alter a statutory scheme even if its assertion is as good or better
than

the

congressional

(internal

one.")

quotation

marks

and

citations omitted) .
Although the Agency argues that the Court should defer to its
decision to implement a voluntary program in lieu of evaluating the
safety

of

the

drugs

and

initiating

necessary,

the

Court

cannot

wi thdrawal

defer because

commands a different course of action.

the

proceedings
statute

if

clearly

See Chevron v. Natural

The FDA relies on SEC v. Citigroup Global Markets, Inc.
), 673 F.3d 158, 164 (2d Cir. 2012), to
support its c
that the Court must defer to an agency's
decision to
tiate or compromise
proceedings. That
case involved the SEC's decision to settle an enforcement
proceeding filed
federal court. The court explained that
"numerous
. affect a litigant's
cision whether to
compromise a case or litigate it to the end[,] includ[ing] the
value of the
icular proposed compromise, the perceived
likelihood of obtaining a still better settlement, the prospects
of coming out better, or worse, after a full t
aI, and the
resources that would need to be expended in the attempt." Id.
27

50

Res. Defense Counicl, Inc., 467 U.S. 837, 842-43, 104 S. Ct. 2778,
2781 (1984)

("If the intent of Congress is clear, that is the end

of the matter;
effect

to

the

for the court,
unambiguously

as well as the agency,
expressed

intent

of

must give
Congress.")

Moreover, the Agency has failed to explain the basis for its claim
that the voluntary program will more effectively achieve the same
results as formal withdrawal proceedings.

The Agency points to the

time and resources involved in holding public hearings.

However,

if any credence is to be given to the Agency's position that the
drug industry intends to comply with the voluntary program, then it
is unclear why the industry would contest formal withdrawal notices
or require time consuming hearings.

Here,

the statutory scheme

requires the Agency to ensure the safety and effectiveness of all
drugs sold in interstate commerce, and, if an approved drug is not
shown to be safe or effective,

the Agency must begin withdrawal

The court further stated that the decision to settle a lawsuit
was a "wholly discretionary matter[] of policy."
Id.
Here, as
discussed extensively in Section lIB, the FDA's decision to
initiate withdrawal proceedings is not wholly discretionary.
Unlike in SEC v. Citigroup, where there was no statutory guidance
governing the agency's decision to sett
the lawsuit, the FDCA
outlines the circumstances under which the FDA may approve an
animal drug and the circumstances under which the FDA must
withdraw that approval.
Moreover, the Court fails to see how the
Court's obligation to give substantial deference to an agency
decision to settle a single lawsuit relates to the present
dispute.
The Agency's decision to forego withdrawal proceedings
for all of the petitioned antibiotics cannot be compared to an
agency's decision to settle a single lawsuit.
51

proceedings.

28

The Agency has forsaken these obligations in the
Guidance # 209,

name of a proposed voluntary program,

and acted

contrary to the statutory language.
Accordingly

I

the

Court

finds

the

Agency's

Petitions to be arbitrary and capricious.

denial

of

the

For over thirty years,

the Agency has been confronted with evidence of the human health
risks

associated

with

the

widespread

antibiotics in food-producing animals,

subtherapeutic
and,

use

of

despite a statutory

mandate to ensure the safety of animal drugs, the Agency has done
shockingly little to address these

sks.

Now,

in responding to

this litigation and two Petitions that have been pending for years,
requesting that the Agency comply with its statutory mandate, the
Agency has refused to make any findings and instead intends to
adopt a voluntary program that is outside the statutory regulatory

28

The FDA describes the regulatory process in Guidance #

209:
FDA considers the issue of antimicrobial resistance as part
of its human food safety review related to new animal drugs used
in food-producing animals.
FDA considers an antimicrobial new
animal drug to be "safe" if the agency concludes that there is
"reasonable certainty of no harm to human health" from the
proposed use of the drug in food-producing animals.
This
standard applies to safety evaluations completed prior to new
animal drug approvals, as well as to those completed for drugs
after approval.
If this safety standard is not met before
approval, the drug cannot be approved.
If safety issues arise
after approval, the [FDCA] provides grounds for withdrawal of
approval of new animal drug applications for safety reasons.
52

scheme.

The adoption of voluntary measures does not excuse the

Agency from

s

merits.

Agency

The

duty to review the Citizen Petitions on their
must

evaluate

the

safety

risks

of

the

petitioned drugs and either make a finding that the drugs are not
shown to be safe or provide a reasoned explanation as to why the
Agency is refusing to make such a finding.
The FDA

led to offer a reasoned explanation, grounded in

the statute, for its refusal to initiate withdrawal proceedings,
and,

therefore,

its

action

was

arbitrary

otherwise not in accordance with law.

and

capricious

and

Massachusetts v. EPA,

549

U.S. at 534, 127 S. Ct. at 1463. 29

Defendants maintain that Massachusetts v. EPA is
inapposite because it involved an agency's complete refusal to
regulate a pollutant. Defendants claim that the present action
is distinguishable because FDA is actively regulating the
relevant drugs - just not in the manner preferred by Plaintiffs.
The Court is not persuaded by this argument. The Court's holding
in Massachusetts v. EPA was based on the EPA's failure "to comply
with [a] clear statutory command." 549 U.S. at 533, 127 S. Ct.
at 1462. Similarly, the FDA has failed to comply with
s
statutory command to evaluate the safety of approved drugs and to
initiate formal withdrawal proceedings if the drug is no longer
shown to be safe. See 21 U.S.C. § 360b{e) (1). Rather than abide
by its statutory guidelines when reviewing the Petitions, the
Agency
led to evaluate the science presented, failed to make a
finding as to the safety of the drugs and drug uses implicated,
and failed to provide a statutorily adequate explanation of why
the Agency had declined to make a finding on the drugs' safety.
The Agency's response is thus arbitrary, capricious, and not in
accordance with law.
See
, 549 U.S. at 534,
127 S. Ct. at 1463 (UIn short, EPA has offered no reasoned
explanation for its refusal to decide whether greenhouse gases
cause or contribute to climate change.
Its action was therefore
29

53

CONCLUSION

For the

foregoing

reasons,

Plaintiffs'

motion for

summary

judgment on their third claim for relief is granted and Defendants'
motion for

summary

judgment

is denied.

The Court remands

the

matter to the Agency for further proceedings consistent with this
Opinion.

The Court emphasizes that it is not compelling the Agency

to reach a certain conclusion.

The Court simply finds that the

Agency's proffered grounds for denying the Petitions were arbitrary
and capricious.
So Ordered.

THEOD6RE H. KATZ

UNITED STATES MAGISTRATE JUDGE

Dated; June 1, 2012

New York, New York

arbitrary, capricious,
. or otherwise not in accordance with
H
law. } (internal quotation marks and citations omitted).

54