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

Filing 70

MEMORANDUM AND OPINION re: #101602 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: Plaintiffs' Motion for Summary Judgment on their first claim for relief is granted and Defendants' Motion for Summary Judgment is denied. Defendants are hereby ordered to initiate withdrawal proceedings for the relevant NADAs/ANADAs, as further set forth within. (Signed by Magistrate Judge Theodore H. Katz on 3/22/2012) (ab) Modified on 3/27/2012 (jab).

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
----------------------------------------X
NATURAL RESOURCES DEFENSE COUNCIL,
INC., et al.,
11 civ. 3562(THK)
Plaintiffs,
-against-

MEMORANDUM
OPINION AND ORDER

UNITED STATES FOOD AND DRUG
ADMINISTRATION, et al.,

Defendants.

----------------------------------------x
THEODORE H. KATZ, UNITED STATES MAGISTRATE JUDGE.

Plaintiffs Natural Resources Defense Council, Inc.
Center for Science in the Public Interest,
Trust,

Public Citizen,

("NRDC"),

Food Animal Concerns

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,
Veterinary Medicine

("CVM"),

Bernadette Dunham,

the Center for
in her official

capacity as Director of the 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.

("APA"),

§

360b(e) (1),

5 U.S.C.

§

and

706(1).

the

Administrative

Procedure

Act

The parties have consented to trial
1

before this Court,

before

the

judgment.

Court
For the

pursuant to 28 U. S . C.

are

the

cross-mot~:

part

reasons

that

§

s

follow,

for

summary

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

ck for purposes

other than disease treatment poses a threat to

health.

1977,

the FDA issued notices announcing its

in~~nt

In

to withdraw

approval of the use of certain antibiotics in I~vestock for the

purposes of growth promotion and feed efficiency, I Which the agency
had found had not been proven to be safe.
notices pursuant to 21 U.S.C.

§

The: FDA issued the

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
animal drug if the Secretary 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 by
methods not deemed reasonably applicable iwhen such
application was approved, evaluated togeth 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 Local CIVil Rule 56.1,
are undisputed.

2

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 further action on
the proposed withdrawals.
In the intervening years, the scientific eVi4ence of the risks
to human health from the widespread use of 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.
after the FDA failed to respond to two Citizen

In May 2011,

Pet~tions

urging the

agency to follow through with the 1977 notices,Plaintiffs filed
this action seeking a court order 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

3

as

antibiotic

resistance.

Specifically,

the

misuse

of

antibiotics

creates

selective

evolutionary pressure that enables antibiotic resistant bacteria to
increase
bacteria,

in

numbers

more

rapidly

increasing the opportunity for

infected by resistant bacteria.
resistant

than

bacterial

infections

antibiotic

susceptible

individuals to become

People who contract antibioticare more

likely to have

longer

hospital stays, may be treated with less effective and more toxic
drugs, and may be more likely to die as a result of the infection.
The FDA considers antibiotic resistance "a mounting public health
problem of global significance."
Am. Compl.")

~ 38i

Answer

In the 1950s,

~

(First Amended Complaint ("First

38.)

the FDA approved the use of antibiotics to

stimulate growth and improve feed efficiency in food-producing
animals, such as cattle, swine, and chickens.

Antibiotics used for

growth promotion are typically administered through animal feed or
water on a

herd-

antibiotics

for

approved

doses

or flock-wide

basis.

growth promotion are
for

"medically important

disease
II

2

treatment.

The approved doses of
typically lower than the
The

administration of

antibiotics to entire herds or flocks of

2 The term "medically important antibiotics" refers to
antibiotic drugs that are important for therapeutic use in
humans.

4

food-producing

animals,

at

"subtherapeutic,,3

levels,

poses

a

qualitatively higher risk to public health than the administration
of such drugs to individual animals or targeted groups of animals
to prevent or

treat

specific

diseases.

(See

Answer

~

34.)

Research has shown that the use of antibiotics in livestock leads
to the development of antibiotic-resistant bacteria that can be
and has been -

transferred from animals to humans through direct

contact, environmental exposure, and the consumption and handling
of contaminated meat and poultry products.

Consequently, the FDA

has concluded that "the overall weight of evidence available to
date

supports

the

conclusion

that

using

medically

important

antimicrobial drugs for production purposes [in livestock] is not
in the interest of protecting and promoting the public health."
(Guidance No. 209, attached as Exhibit B ("Ex. B") to Declaration
of

Assistant

De c 1.

II )

united

States

Attorney

Amy A.

Barcelo

("Barcelo

at 13.}

III. Penicillin and Tetracyclines
The present action pertains to the use of three different

The term "subtherapeutic was commonly used in the 1960s
and 1970s to refer to any use of antibiotics for purposes other
than disease treatment and prevention, including growth promotion
and feed efficiency in animals. Although FDA no longer uses the
term, in this Opinion the Court uses the term "subtherapeutic to
refer to the use of antibiotics in food-producing animals for
growth promotion and feed efficiency.
3

ll

ll

5

antibiotics

in

animal

tetracycline

feed:

penicillin

chlortetracycline

("tetracyclines") .

and

and

two

forms

of

oxytetracycline

Pursuant to the FDCA, any "new animal drug" 4

that is introduced into interstate commerce must be the subject of
an FDA approved new animal drug application

("NADA")

or,

respect to generic drugs, an abbreviated NADA ("ANADA").
U.S.C.

§

360b(b)-(c).

with
See 21

Drug companies that submit NADAs/ANADAs are

typically referred to as

"applicants"

or "sponsors."

The

FDA

lawfully issued NADAs and ANADAs for penicillin and tetracyclines
in the mid 1950s.

Since that time, penicillin has been used to

promote growth in chickens
have

been used

cattle

l

I

to promote

turkeys
growth

I

and swine

l

and tetracyclines

in chickens,

turkey,

swine

I

and sheep.

In the mid 1960s 1 the FDA became concerned that the long-term
use of antibiotics,
food-producing
health.

including penicillin and tetracyclines

animals might pose

As a result

l

threats

I

in

to human and animal

in 1970, the agency convened a task force to

study the risks associated with the use of antibiotics in animal
feed.

The task force was composed of scientists from the FDA, the

National Institutes of Health, the U.S. Department of Agriculture,

A new animal drug is defined, in part l as "any drug
intended for use for animals other than man, including any drug
intended for use in animal feed but not including such animal
feed.
See 21 U.S.C. § 321(v).
4

I'

6

the Center for Disease Control,

as well as representatives from

universities and industry.

In 1972, the task force published its

findings,

(1)

concluding that:

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 antibiotics in their feed may serve
as a reservoir of antibiotic pathogens,
infections;

which can produce human

(3) the prevalence of bacteria carrying transferrable

resistant genes for multiple antibiotics had increased in animals,
and

the

increase

was

related

to

the

antibiotic-resistant bacteria had been

use

of

found

antibiotics;
on meat

(4)

and meat

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

force

See Antibiotic and Sulfonamide Drugs in

37 Fed. Reg.

made

several

2,444,

2,444-45

recommendations,

(Feb.

I,

1972).

including

that

The
(1)

antibiotics used in human medicine be prohibited from use in animal
feed unless they met safety criteria established by the FDA, and
(2) several specific drugs, including penicillin and tetracyclines,
be reserved for therapeutic use unless they met safety criteria for
non-therapeutic use.

See

In response to the findings of the task force,

the FDA,

in

1973, issued a regulation providing that the agency would propose
to withdraw approval of all subtherapeutic uses of antibiotics in
7

animal

feed

submitted

unless

data

drug sponsors

within

the

next

and other
two

interested parties

years

"which

resolve[d]

conclusive

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

animals .

. under specific cri teria" established by the FDA.

Antibiotic and Sulfonamide Drugs in the Feed of Animals, 38 Fed.
Reg. 9,811, 9,813 (Apr. 20, 1973)
135.109i

renumbered at

21

C.F.R.

(codified at former 21 C.F.R.

One of the most

558.15).

§

§

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

The FDA regulation required that "[a]n antibacterial

drug fed at subtherapeutic levels to animals must be shown not to
promote
medicine.

increased

resistance

to

Penicillin-Containing

II

antibacterials
Premixes

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

used

Notice

in

human

("Penicillin

(Aug. 3D, 1977).

The other

health safety criteria involved showing that use of antibiotics
would not increase salmonella in animals, would not increase the
pathogenicity of bacteria, and would not increase residues in food
ingested by man, which may cause "increased numbers of pathogenic
bacteria

or

an

increase

in

the

resistence

antibacterial agents used in human medicine.
Over the next two years,

II

of

pathogens

to

See id.

the Bureau of Veterinary Medicine

8

(\\BVM")

a subdivision of the FDA,

,5

reviewed the data submitted by

drug sponsors to support the subtherapeutic use of antibiotics.
April

20,

1975,

criteria for
The

all

data

antibiotic

concerning

drugs

safety

and

efficacy

had been received.

was assisted by a

BVM

the

By

sUb-committee of the FDA's

National Advisory Food and Drug Committee ("NAFDC") in its review
of

the

The

data.

NAFDC

sUb-committee

issued

a

report

and

recommendations on the subtherapeutic use of penicillin in animal
feed,

which

"recommended

the

NAFDC

that

subtherapeutic uses

adopted

FDA

in

immediately

of penicillin,

efficiency, and disease control."
committee

made

1977.

certain

withdraw
i. e.,

rd.

approval

NAFDC

for

the

growth promotion/feed

Similarly, the NAFDC sub­

recommendations

tetracyclines in animal feed.

The

regarding

the

use

of

Specifically, for tetracyclines, the

sub-committee recommended that the FDA "(1) discontinue their use
for growth promotion and/or feed efficiency in all animal species
for which effective substitutes are available, (2) permit their use
for disease control where effective alternate drugs are unavailable

. , and
through
Tetracycline

5

(\\CVM")

(3)

control

the

distribution of

the

tetracyclines

a veterinarian'S order to restrict their use."
(Chlortetracycline

and

Oxytetracycline)-Containing

The BVM was renamed the Center for veterinary Medicine

in 1984.

9

Premises; Opportunity for Hearing ("Tetracycline Notice"), 42 Fed.
Reg. 56,264, 56,266 (Oct. 21, 1977).

The NAFDC rejected the first

two recommendations, but adopted the third recommendation.
IV.

id.

The 1977 NOOHs
After carefully considering the recommendations of the NAFDC

and the NAFDC sub-committee, the Director of the BVM issued notices
of an opportunity for hearing ("NOOHs") on proposals to withdraw
approval of all subtherapeutic uses of penicillin in animal feed,
see Penicillin Notice, 42 Fed. Reg. at 43,772, and, with limited
exceptions,

all

subtherapeutic

uses

of

oxytetracycline

and

chlortetracycline in animal feed, see Tetracycline Notice, 42 Fed.
Reg. at 56,264.

In the Penicillin Notice, the Director reported

that

the

"[n] one

of

specified human and animal

health

safety

criteria [for the subtherapeutic use of antibiotics in animal feed]
have been satisfied.
43,775.

"

With respect

to

Penicillin Notice, 42 Fed. Reg. at
the

transfer of

antibiotic resistant

bacteria, the Director surveyed the available data and found that
(1)
was

the pool of bacteria carrying transferrable resistance genes
increasing;

subtherapeutic

(2)
use

the
of

increase

penicillin

antibiotic-resistant bacteria were

was
in

due
animal

in

part

feed;

to

the

and

(3)

transferred from animals

to

humans as a result of direct human-animal contact, the consumption
of contaminated food,

and the widespread presence of resistant
10

bacteria in the environment.

See id. at 43,781.

Studies submitted

by penicillin applicants and sponsors had failed to rebut theses
findings.

See

Based on this evidence, the Director of the BVM

proposed to withdraw approval of all NADAs!ANADAs for the use of
peni

llin

in

animal

feed

on

the

grounds

products are not shown to be safe.

/I

"that

drug

at 43,792.

rd.

the [se]

The

Director further cautioned that "[t]he evidence, in fact, indicates
that such penicillin use may be unsafe

/I

Similarly, the Director of the BVM announced health and safety
concerns

regarding

animal feed.

the

subtherapeutic

use

of

tetracyclines

in

The Director explained that " [e]vidence demonstrates

that the use of subtherapeutic levels of the tetracyclines . . . in
animal feed contributes to the increase in antibiotic resistant

~

Coli

to

and

in

Salmonella.

the

subsequent

Further! some strains of

both man and animals.
'I

transfer

of

this

resistance

Coli and Salmonella infect

Thus! the potential for harm exists .

Tetracycline Notice! 42 Fed. Reg. at 56,267.

The Director

also noted that, in response to the 1972 FDA regulation announcing
the health safety criteria for use of antibiotics in animal feed

l

the studies submitted by the holders of tetracyclines NADAs!ANADAs
"were inconclusive because the studies were inappropriate./1

rd.

The

that

Director

satisfies

the

concluded

that

requirements

he

"is

for
11

unaware

of

demonstrating

evidence
the

safety

of

extensive use of subtherapeutic tetracycline-containing premixes
Id.

II

at 56,288.

Based on this evidence,

proposed to withdraw approval

of

the Director

certain NADAs/ANADAS

for

the

subtherapeutic use of tetracyclines "on the grounds that they have
not been show to be safe.
In response
firms,

to

agricultural

the

II

1977

NOOHS,

organizations,

approximately twenty drug
and

individuals

requested

Penicillin and Tetracycline in Animal Feeds Hearing,

hearings.

43 Fed. Reg. 53,827, 53,828 (Nov. 17, 1978).

On November 9, 1978,

the Commissioner of the FDA granted the requests for hearings,
stating that "there w[ould] be a formal evidentiary public hearing
on [the proposed withdrawals] "
stated that
practicable."

a

date

for

at 53,827.

the hearing would be

Id. at 53,827-28.

The Commissioner
set

"as

soon as

According to the statutory and

regulatory scheme, at the hearing, the drug sponsors would have the
burden of proving that the drugs were in fact safe.

(See FDA,

Final Decision of the Commissioner, Withdrawal of Approval of the
New

Animal

Drug

Application

for

Enrofloxacin

in

Poultry

("Enrofloxacin Decision"), attached as Ex. N to Barcelo Decl. at 8­
9. )

V.

The FDA's Actions Following the Issuance of the 1977 NOOHs
The Commissioner never set a date for the hearings on the

BVM's proposal to withdraw approval of the use of penicillin and
12

tetracyclines in animal feed.
Congressional

committees

In the late 1970s and early 1980s,

issued

three

reports

that

contained

statements that the FDA interpreted as requests to postpone the
withdrawal hearings pending further research.
1978,

Specifically,

in

the House Committee on Appropriations "recommend[ed]1f that

the FDA conduct research regarding "whether or not the continued
subtherapeutic use of [penicillin and tetracyclines] would result
in

any

significant

approval.

human

health

risk"

before

revoking

H.R. Rep. No. 95 1290, at 99 100 (1978).

such

In 1980, the

House Committee on Appropriations requested that the FDA "hold in
abeyance any implementation" of the proposed revocation pending
further research.
1981,

the

request.

H.R. Rep. No.

Senate

Committee

on

96 1095,

at 105-06

Appropriations

See S. Rep. No. 97-248, at 79 (1981).

(1980).

made

a

In

similar

Importantly, none

of these recommendations was adopted by the full House or Senate,
and none was passed as law.
Regardless
statements,

of

the

FDA

the

legal

never

effect
held

of

these

hearings

on

Congressional
the

proposed

withdrawals, and instead engaged in further research on the risks
associated with the subtherapeutic use of antibiotics in foodproducing animals.

Soon after the initial House Appropriations

Committee request, the FDA contracted with the National Academy of
Sciences

("NAS")

to assess the human health consequences of the
13

subtherapeutic use of penicillin and tetracyclines in animal feed
by evaluating existing data, and to recommend areas for additional
research.

The

conclusions

about

antibiotics

NAS

in

issued

the

safety

animal

epidemiological studies.

its

report

of

feed

the

and

in

1980,

drawing

subtherapeutic
recommending

use

no
of

additional

The FDA then contracted with the Seattle­

King County Department of Public Health ("Seatt

-King County") and

the Institute of Medicine for further research.

In 1984, Seattle­

King County published its study, finding support for FDA's concerns
about the risks posed by antibiotics in animal feeds.

For example,

the study found that Campylobacter bacteria were likely transferred
from

chickens

to

humans

through

the

consumption

of

poultry

products; samples of such bacteria taken from poultry products and
humans

exhibited

resistance;

and

"surprisingly
drug resistant

high"

rates

Campylobacter

resistant genes to other bacteria.

of

tetracycline

could

transfer

Excerpt from Seattle-King

County Department of Public Health 1984 Report, attached as Ex. G
to Declaration of Jennifer A.
169.}

Sorenson ("Sorenson Decl.") at 3,

The Institute of Medicine issued its report in 1988.

the NAS,

Like

it could not conclude that the subtherapeutic use of

antibiotics in animal feed was safe.

However,

it found several

sources of "indirect evidence implicating subtherapeutic use of
antimicrobials in producing resistance in infectious bacteria that
14

causes

a

potential

human

health

hazard.

Excerpt

II

from

Institute of Medicine 1988 Report, attached as Ex. H to Sorenson
Decl. at 194.)
After

the publication of

the

Seattle-King County and the

Institute of Medicine studies, the FDA took little action on the
still-pending

NOOHs.

1977

In

the

1983,

Commissioner

denied

requests from several drug sponsors to rescind the 1977 NOOHs.
Penicillin and Tetracycline in Animal Feeds, 48 Fed. Reg.
4, 556

(Feb.

1,

1983).

See

4,554,

The Commissioner explained that the 1977

NOOHs "represent [ed] the Director's formal position that use of the
drugs

is

not

"concur [red]

If

shown

to

be

safe"

and

that

the

Commissioner

Id.

In 2003, the

with the decision of the Director.

FDA published a proposed rule that referenced the risks to human
health from the subtherapeutic use of antibiotics in animal feed.
New

Animal

Drugs;

Removal

of

Obsolete

and

Redundant

Regulations, 68 Fed. Reg. 47,272, 47,272 (Aug. 8, 2003).

The FDA

referenced the NAS and Institute of Medicine reports, as well other
relevant studies.

The FDA "( 1 )

that the risks were neither proved nor disproved,

[c] onc 1uded

(2) did not deny

there was some degree of risk, and (3) did not conclude that the
continued subtherapeutic use of peni

llin and tetracyclines in

animal feed is safe.

the BVM,

1I

In 2004,

Center of Veterinary Medicine

("CVM
15

If

),

now known as the

sent letters to several

manufacturers

of

approved

animal

feed

products

containing

penicillin and tetracyclines, explaining that" [t] he administrative
record does not contain sufficient information to alleviate the
CVM's concerns about the use of

[these]

product [s]

and

[their]

possible role in the emergence and dissemination of antimicrobial
resistance."

(FDA Letters to Drug Sponsors (2004), attached as Ex.

N to Sorenson Decl. at 2.)

The FDA invited manufacturers to meet

with the agency to discuss the agency's findings.
On
Guidance

June

28,

entitled

Antimicrobial

at

The

Drugs

in

the

FDA

JUdicious

released
Use

a

of

Food-Producing

non-binding

Medically

Animals

Draft

Important

("2010

Draft

(See Guidance No. 209, attached as Ex. B to Barcelo

Guidance") .
Decl.

2010,

In the Draft Guidance,

1.)

the

FDA reviewed recent

scientific studies on the risks posed by the subtherapeutic use of
antibiotics

in

animal

feed,

including

a

1997

World

Health

Organization expert committee report that "recommended that the use
of

antimicrobial

drugs

for

growth

promotion

in

animals

be

terminated if these drugs are also prescribed for use as anti
infective agents in human medicine or if they are known to induce
cross-resistance to antimicrobials used for human medical therapy."
(See

at 8.)

After reviewing the scientific evidence, the FDA

concluded that "the overall weight of evidence available to date
supports

the

conclusion

that
16

using

medically

important

antimicrobial drugs for production purposes is not in the interest
of protecting and promoting the public health."

(Id. at 13.)

The

FDA announced two non-mandatory principles to guide the use of

(1) "[tlhe use of medically important

antibiotics in animal feed:

antimicrobial drugs in food-producing animals should be limited to
those

uses

that

are

considered

necessary

for

assuring

animal

health[;]" and (2) "[t]he use of medically important antimicrobial
drugs in food producing animals should be limited to those uses
that include veterinary oversight or consultation."

(Id. at 16

17. )
On December 16,

2011,

nearly twenty-five years after their

initial publication and during the pendency of this action, the FDA
Withdrawal of Notices of Opportunity

rescinded the 1977 NOOHs.
for a Hearing;

Penicillin and Tetracycline Used in Animal Feed

("NOOH Withdrawals"), 76 Fed. Reg. 79,697, 79,697 (Dec. 22, 2011).
The FDA explained that it was rescinding the NOOHs because the "FDA
is engaging in other ongoing regulatory strategies developed since
the publication of the 1977 NOOHs" and that if the FDA were to move
forward with the NOOHs
reflect current data,

it would need to

information,

any withdrawal proceedings. 1t

and pol

Id.

"update the NOOHs

to

ies" and "prioritize

The FDA noted that "although

[it] is withdrawing the 1977 NOOHs, FDA remains concerned about the
issue

of

antimicrobial

resistance."
17

The

FDA

explained

that

the

withdrawal

of

the

NOOHs

"should

not

be

interpreted as a sign that FDA no longer has safety concerns or
that FDA will not consider re-proposing withdrawal proceedings in
the future, if necessary." rd. at 79,698.
VI.

The Present Action
Plaintiffs fi

the present action on May 25, 2011, alleging

that the FDA's fai

to withdraw approval of the subtherapeutic

use of penicillin and tetracyclines pursuant to the 1977 NOOHs
constituted an agency action unlawfully withheld or unreasonably
delayed in violation of the APA, 5 U.S.C.
21 U.S.C.

§

360b{e) (1).6

§

706(1), and the FDCA,

Plaintiffs seek a Court order compelling

6 The First Amended Complaint contained an additional claim
pertaining to two Citizen Petitions submitted by Plaintiffs to
the FDA in 1999 and 2005.
First Amended Compl. " 99-101.)
In those Citizen Petitions, Plaintiffs petitioned the FDA to
immediately withdraw approval for certain uses of penicillin and
tetracyclines in livestock given the evidence of the risks posed
to human health.
(See
" 82 87.)
The FDA never issued a
final response to these pet ions. On November 7, 2011, the FDA
issued final responses to both Citizen Petitions, denying the
requested action.
(See Stipulation and Order, dated Jan. 6,
2012).
Consequently, Plaintiffs withdrew their claim as to the
Citizen Petitions as moot, and the Court dismissed the claim
without prejudice.
) On January 9, 2012, Plaintiffs
filed a motion for leave to file a supplemental complaint, which
the Court granted on January 31, 2012.
(See Scheduling Order,
dated Jan. 31, 2012.)
Plaintiffs filed their Supplemental
Complaint on February 1, 2012, which added a claim that the FDA's
f
responses to the 1999 and 2005 Citizen Petitions were
"arbitrary, capricious, an abuse of discretion, or otherwise not
in accordance with law, in violation of the [FDCA], 21 U.S.C. §
360b, and the APA, 5 U.S.C. § 706(2)."
(Supplemental CompI. ,
38. )

18

the

FDA

to

penicillin

withdraw
and

approval

tetracyclines

for
in

the

animal

subtherapeutic
feed[

unless [

use

of

after

a

hearing[ the drug uses at issue are determined to be safe.
Amended CompI.

~

lOl(C).)

Plaintiffs further request that the

Court set a deadline by which the FDA must hold hearings and issue
a

final

decision

on

the

id. )

withdrawals.

maintain that under the FDCA[7 21 U.S.C.

§

Plaintiffs

360b(e) (1), once the FDA

found that the subtherapeutic use of penicillin and tetracyclines
in animal feed was not shown to be safe to humans, the agency was
statutorily obligated to withdraw approval of those uses[ unless
the drug sponsors demonstrated the safety of the drugs.
contend that withdrawal was not
event,

legally required[

Defendants
and t

in any

the issue is now moot because the 1977 NOOHs have been

withdrawn.

Plaintiffs reply that the recent withdrawal of the

NOOHs was in response to this litigation and has no bearing on the
FDA's obligation to act.
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

sue of material fact to

within the internal numbering of the FDCA, the statute at
issue in this case
§ 512.
7

19

be tried,

and that the facts as to which there is no such issue

warrant judgment for the moving party as a matter of
Celotex Corp. v. Catrett, 477 U.S. 317,
2552-53 (1986)
Cir. 2004)

i

law.

322-23, 106 S. Ct. 2548,

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

i

Shannon v. N.Y. City Transit Auth., 332 F.3d 95, 98 (2d

Cir. 2003).

The burden of demonstrating the absence of any genuine

dispute as to a material fact rests upon the party seeking summary
judgment, see Adickes v. S. H. Kress & Co., 398 U.S. 144, 157, 90
S. Ct. 1598, 1608 (1970), but once a properly supported motion for
summary judgment has been made, the burden shifts to the nonmoving
party to make a

sufficient

showing

to establish the essential

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 (2d
Cir. 2003)

(citing Celotex, 477 U.S. at 322

Where,

here

as

judgment,

l

a

court

considers

1

106 S. Ct. at 2552).

cross-motions

for

summary

the court applies the same legal principles and "must

evaluate each party1s motion on its own merits

l

taking care in each

instance to draw all reasonable inferences against the party whose
motion is under consideration.
Turner, 378 F.3d 133
Here,

1

1I

Make the Road by Walking, Inc. v.

142 (2d Cir. 2004)

(citations omitted) .

the parties do not dispute the essential facts.

The

only issue before the Court is the legal conclusion resulting from
those facts.
20

B.

The Administrative Procedure Act

"The APA authorizes suit by '" [a] person suffering legal wrong
because of agency action,

or adversely affected or aggrieved by

agency action within the meaning of the relevant statute."
v. S. Utah Wilderness Alliance
ct. 2373, 2378 (2004)
"agency

action"

551(13).8

("SUWA"), 542 U.S. 55, 61, 124 S.

(quoting 5 U.S.C.

includes

the

Norton

§

"failure

702).
to

Under the APA, an

act.

II

5

U.S.C.

§

Section 706(1) provides relief for an agency's failure

to act by empowering reviewing courts to

"compel agency action

unlawfully withheld or unreasonably delayed[.]

II

see SUWA, 542 U.S. at 62; 124 S. Ct. at 2378.
has made clear that

§

5 U.S.C.

§

706(1);

The Supreme Court

706(1) applies only when an "an agency failed

to take a discrete agency action that it is required to take.
SUWA, 524 U.S. at 64, 124 S. Ct. at 2379

1I

(emphasis in original);

see also Benzman v. Whitman, 523 F.3d 119, 130 (2d Cir. 2008).

The

limit to discrete actions precludes a court from authorizing "broad
programmatic attack[s]" on agency policy, and the limit to legally
required actions ensures that a court will not interfere with an
agency's discretionary functions.
at 2379-80.

Accordingly,

See id. at 64-65, 124 S. Ct.

"when an agency is compelled by law to

Specifically, the APA provides that "'agency action'
includes the whole or a part of an agency rule, order, license,
sanction, relief, or the equivalent or denial thereof, or failure
to act[.]" 5 U.S.C. § 551(13).
8

21

act within a certain time period, but the manner of its action is
left to the agency's discretion, a court can compel the agency to
act, but has no power to specify what the action must be.
65,

124 S.

Ct.

at 2380.

1I

Id. at

The Court further explained that the

purpose of the limitations under

706(1)

§

"is to protect agencies

from undue judicial interference with their lawful discretion, and
to avoid judicial entanglement in abstract policy disagreements
which courts lack both expertise and information to resolve."

Id.

at 66, 124 S. Ct. at 2381.
II.

Application
Here,

the Director of

the

tetracyclines NOOHs pursuant

BVM,

to

21

issued the penicillin and
U.S.C.

§

360b(e) (1),

governs the withdrawal of approval of NADAs/ANADAs.
§

Specifically,

360b{e) (1) reads:

The Secretary shall/ after due notice and opportunity for
hearing to the applicant, issue an order withdrawing
approval of an application . . . with respect to any new
animal drug if the Secretary finds .
(B) that new
evidence not contained in such application or not
available to the Secretary until after such application
was approved/ or tests by new methods, or tests by
methods not deemed reasonably applicable when such
application was approved/ evaluated together with the
evidence available to the Secretary when the application
was approved/ shows that such drug is not shown to be
safe for use under the conditions of use upon the basis
of which the application was approved .

22

it

which

21 U.S.C.

§

360b(e} (1) (B}.9

In order to obtain the relief they

seek, Plaintiffs must establish that

§

360b{e) (1) legally requires

the FDA to take a discrete action.
A.

Discrete Action

Plaintiffs maintain that

§

36 Ob (e) (1)

prescribes a

set of

discrete actions to be taken by the FDA in the event that new
evidence shows that a new animal drug has not been shown to be
The

safe.

statute

requires

that

prior

to

issuing

an

order

withdrawing approval of a NADA/ANADA, the FDA must provide notice
to the drug sponsors and an opportunity for a hearing.
U.S.C.

§

360b{e) (1).

See 21

If a drug sponsor or other interested party

timely requests a hearing, the FDA must hold a public evidentiary
suing a final withdrawal order.

hearing prior to

The FDA has promulgated numerous regulations to guide the
withdrawal process.

First,

the notice issued by the FDA "must

contain enough information to provide the respondent a
opportunity to identi
Div. of Rhodia,

material issues of fact."

Inc. v. Food & Drug Admin.

F.2d 975, 983 (D.C. Cir. 1974)
&

Clark Div. v. Food

&

i

genuine

Hess & Clark,

("Hess & Clark"), 495

see also Rhone-Poulenc, Inc., Hess

Drug Admin.

("Rhone-Poulenc"), 636 F.2d 750,

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

23

752

(D.C.

applicant

Cir.

1980);

requests

explanation

of

a

why

21 C.F.R.
hearing,

the

514.200(a).

If

must

in writing,

§

he

NADA/ANADA

submit,

"should

not

a NADA/ANADA

be

an

withdrawn,

together with a well organized and full-factual analysis of the
clinical and other investigational data he is prepared to prove in
support of his opposition to the [proposed withdrawal] "
§

514.200(c).

fails

to

21 C.F.R.

If, in his application for a hearing, an applicant

raise

a

genuine

and

substantial

Commissioner may deny the request

for a

issue

of

fact,

the

hearing and summarily

withdraw approval for the NADA/ANADA based on the data presented in
; Hess & Clark,

the original notice.

495 F.2d at 984-85

(approving the FDA's use of the summary judgment procedure where
the NOOH presents a

"prima facie case for withdrawal").

If a

hearing is granted, "the issues will be defined, an Administrative
Law Judge will be named, and he shall issue a written notice of the
time and place at which the hearing will commence."
514.200 (c) .

21 C.F.R.

The purpose of the hearing is to provide a

§

"fair

determination of relevant facts consistent with the right of all
interested persons to participate .

"

21 C.F.R.

§

12.87.

At

the hearing, the FDA has the initial burden of producing evidence
that the drug has not been shown to be safe, which is generally
contained in the notice.

See Rhone-Poulenc,

(Enrofloxacin Decision at 8.)

636

F.2d at 752;

However, the drug sponsor has the
24

"burden of persuasion on the ultimate question of whether
drug] is shown to be safe."
Rhone-Poulenc,
hearing,

(Enrofloxacin Decision at 9)

F.2d at

636

752.

As

i

[the

see also

soon as possible after a

the presiding officer issues an initial decision that

includes findings of fact, conclusions of law, a discussion of the
reasons

for

the

findings

See 21 C.F.R.

citations.

and

conclusions,

12.120

§

(a)-(b).

and

appropriate

A participant in a

hearing may appeal an initial decision to the Commissioner.
C.F.R.

§

See 21

12.125(a).

Defendants

argue

that

given

the

procedural

complexity of

issuing a notice and holding a hearing, which may take months or
years to complete, the relief sought by Plaintiffs is not discrete.
The Court disagrees.

Upon a finding that a new animal drug has not

been

safe,

shown

to

be

§

360b(e) (1)

and

the

accompanying

regulations require the FDA to implement several related discrete
actions:

(1)

provide notice of the FDA's finding and intent to

withdraw approval;

(2) provide an opportunity for a hearing to the

relevant animal drug sponsors;

(3) if an applicant timely requests

a hearing and raises a genuine issue of fact, hold a hearing; and
(4)

if the applicant fails to show that the drug is safe,

the

Commissioner must issue an order withdrawing approval of the drug.
The first three steps are statutory precursors to issuing the final
withdrawal order.

The APA defines "agency action'! to include the
25

issuance of an order, see 5 U.S.C.

551(13), and the Supreme Court

§

has defined an order as a discrete agency action.
U.S. at 62, 124 S. Ct. at 2378.

See SUWA, 542

Moreover, the APA anticipates that

an order will be preceded by a hearing or a similar process, as it
defines "adjudication" as the "agency process for formulation of an
order[.]"

551(6)

(defining

"order" as "the whole or part of a final disposition .

. of an

agency

5 U.S.C. § 551(7); see also 5 U.S.C.

in

licensing.") .

a

matter

other

The fact that

than
§

§

rulemaking

360b(e) (1)

but

including

requires notice and an

opportunity for a hearing prior to the issuance of a withdrawal
order does not undermine the fact that the requested relief is a
discrete agency action.

See id.

"broad programmatic attack"
rather,

Plaintiffs are not launching a

on the FDA's animal drug policies;

Plaintiffs have identified certain new animal drugs that

the agency has publicly concluded are "not shown to be safe" and is
requesting that the agency move forward with its statutory duty to
hold the

requested hearings

and withdraw approval

sponsors fail to show that the drugs are safe. 10

if

the drug

See SUWA 542 U.S.

at 64, 124 S. Ct. 2379-80 (contrasting a "discrete" agency action
with a "broad programmatic attack") .

10 Plaintiffs have not asked the Court to direct the outcome
of the requested hearings or to compel Defendants to issue a
final withdrawal order.

26

B.

Legally Required Action

The parties dispute whether, given the facts of this case, §
360b(e) (1)
withdrawal

legally requires the Commissioner of the FDA to hold
proceedings

tetracyclines

for

the

NADAs/ANADAS.

relevant

Defendants

penicillin

acknowledge

that

and
§

360b(e) (1) contains language mandating the Secretary to act ("[t]he
Secretary shall, after due notice and opportunity for hearing to
the

applicant,

issue

application . .

an

order

withdrawing

if the Secretary finds . . . ").

of Home Builders v. Defenders of Wildlife,
127

S.

Ct.

language
duty)

i

(2001)

2518,

2531-32

"shall approve"

Lopez v.

approval

Davis,

(2007)

of

an

See Nat'l Ass'n

551 U.S.

(interpreting

644,

the

661-62,

statutory

to impose upon the agency a mandatory
531 U.S.

(noting Congress'

230,

241,

121 S.

"use of a mandatory

Ct.

714,

'shall'

722
to

impose discretionless obligations"); Lexecon Inc. v. Milberg Weiss
Bershad Hynes & Lerach, 523 U.S. 26, 35, 118 S. Ct. 956, 962 (1998)
( \\ [T] he mandatory

'shall'

normally creates an obligation

impervious to judicial discretion.").

However, Defendants disagree

with Plaintiffs as to when and how the Secretary's duty to act
triggered.

Defendants contend that the statute only requires the

Secretary to withdraw approval of a NADA/ANADA if the Secretary
makes a finding after a formal hearing.

Since the FDA never held

hearings and has now withdrawn the 1977 NOOHs,
27

Defendants argue

that no findings have been made and no further action
Plaintiffs contend that under

§

360b(e) (1)

required.

the Secretary makes a

finding prior to a hearing, and that upon making such a finding,
the Secretary is legally required to withdraw approval of a drug,
unless the drug sponsor requests a hearing and shows that the drug
is safe.

They further argue that the FDA's recent withdrawal of

the 1977 NOOHs does not disturb the agency's original findings and
that the FDA is legally required to hold withdrawal proceedings for
the relevant penicillin and tetracyclines NOOHs.

The question

before the Court is whether the FDA is legally required to proceed
with the hearing and withdrawal process.
1.

Statutory Interpretation

a.

Legal Standard

In interpreting a statute, a court "must give effect to the
unambiguously expressed intent of Congress.

II

Chevron, U. S. A., Inc.

v. Natural Res. Def. Council, Inc. t 467 U.S. 837
2778,

2781

begin [s]

(1984).

with

the

t

843/ 104 S. Ct.

"To ascertain Congress's intent
statutory

text

because

if

unambiguous/ no further inquiry is necessary.1I
Chase & CO.

t

498 F.3d 111/ 116 (2d Cir. 2007)

its

t

[a court]

language

Cohen v. JP Morgan
(citations omitted)

see also Tyler v. Douglas, 280 F.3d 116/ 122 (2d Cir. 2001)
the statutory terms are unambiguous,

is

i

('''If

[a courttsJ review generally

ends and the statute is construed according to the plain meaning of
28

its words.'II) {quoting Sullivan v. Cnty. of Suffolk, 174 F.3d 282,
285

(2d Cir.

1999».

Statutory interpretation must

account the "structure and grammar" of the provision.
v. United States,

U.S.

take

See B10ate

, --, 130 S. Ct. 1345, 1354-55 (2010).

\\ If the statutory language is ambiguous, however,

[a court]

'resort first to cannons of statutory construction,

and,

determine the intent of Congress.

II

to

Cohen, 498 F.3d at 116 {quoting

Daniel v. Am. Bd. of Emergency Med.,
the intent

will

if the

[statutory] meaning remains ambiguous, to legislative history'

2005».

into

428 F.3d 408,

423

(2d Cir.

Congress remains unclear, a court will

defer to an agency's interpretation of the statute, so long as it
is "reasonable."

See Chevron, 467 U.S. at 843-44,

104 S. Ct. at

2782.
b.

Application: Findings Pursuant to

Here,

the

§

360b(e) (1)

statute unambiguously commands

the

withdraw approval of any new animal drug that he finds

Secretary to
not shown

to be safe, provided that the sponsor of the animal drug has notice
and an opportunity for a hearing.

See 21 U.S.C.

§

360b{e) (1).

The

statute does not explicitly state the order in which this process
must occur.

Defendants maintain that the Secretary can only issue

a finding after a hearing, whereas Plaintiffs claim the Secretary
makes

a

finding

first,

which

then

triggers

the

Secretary's

obligation to provide notice and an opportunity for a hearing.
29

The Court finds that Plaintiff/s interpretation provides a
common

sense

reading

of

grammatical structure.
shall

after

l

applicant

1

due

the

statute

based

on

its

text

and

The statute states that "[t]he Secretary

notice

and

opportunity

for

hearing

issue an order withdrawing approval of a[]

to

the

[NADA/ANADA]

if the Secretary finds . . . [that a drug is not shown to be
safe]

The "after due notice and opportunity for hearingll

II

clause

is

setoff by commas and

immediately precedes

"issue an order withdrawing approval

1 II

clause modifies the "issue an order

ll

clause.

See United States v.

(S.D.N.Y.

1990)

closest to it)

(citing W. Strunk

Style 30 (3d ed. 1979)).

indicating that the "notice

l

ll

clause and not the findings

Liranzo

(interpreting a

the words

l

729 F.

Supp.

1012 1

1014

modifier to apply to the verb
Jr. & E.B. White

l

The Elements of

AccordinglYI the statute only requires

the Secretary to give notice and provide an opportunity for a
hearing before issuing an order of withdrawal and not before making
findings.

Under this reading

animal drug has

1

if the Secretary finds

not been shown to be

safe

required to withdraw approval of that drug

l

1

he

is

1

636 F.2d at 752

statutorily

provided that the drug

sponsor has notice and an opportunity for a hearing.
Poulenc

that an

See Rhone

("[T]he Commissioner must withdraw his

approval [of an animal drug] whenever he finds that 'new evidence
shows that such drug is not shown to be safe
30

•

1 II )

(quoting 21 U.S.C. § 360b(e) (1) (B)).

If, after a hearing, the drug

sponsor has not met his burden of proving the drug to be safe, the
secretary must issue a withdrawal order.11
The text and grammar of other provisions within
this interpretation.

For example,

§

360b support

§

360b(d) (1) explicitly requires

the Secretary to provide notice and an opportunity for a hearing
before making findings regarding the approval or refusal of a NADA.
21 U.S.C.

§

360b(d) (1) .

Section 360b (d) (1)

reads:

"If the

Secretary finds, after due notice to the applicant . . . and giving
him an opportunity for a hearing,

he shall issue an order

refusing to approve the application."

By placing the

"notice"

clause immediately after the phrase "[iJf the Secretary finds,"

§

360b(d) (I) clearly requires notice and an opportunity for a hearing
prior to the issuance of findings by the Secretary.
Congress used such language in
language

in

§

360b{e) (1)

§

supports

360b(d) (I)
the

The fact that

and used different

Court's

conclusion that

notice and an opportunity for a hearing are not required before the
Secretary makes findings under the latter provision.
v. Westchester Cnty., 661 F.3d 128, 142 (2d

r. 2011)

Novella
{explaining

that the presence of a term in one provision and not in another was

11 Admittedly, the Secretary will make a second set of
findings after a hearing, but the initial findings trigger the
mandatory withdrawal process and, if not rebutted, provide a
basis for mandatory withdrawal.
31

deliberate and meaningful) .
Moreover,

360b(e) (1)

§

includes a

specific note about the

notice and hearing requirement when the Secretary finds that a new
animal drug poses an imminent risk to humans or animals,
indicates that findings are made before a hearing.

which

Specifically,

the statute states that

[i]f the Secretary (or in his absence the officer acting
as Secretary) finds that there is an imminent hazard to
the health of man or of the animals for which such drug
is intended, he may suspend the approval of such
application immediately, and give the applicant prompt
notice of his action and afford the applicant the
opportunity for
an expedited hearing under
this
subsection .

21 U.S.C.

§

360b(e) (1).

making findings

This provision anticipates the Secretary

in advance of a hearing i

otherwise,

the clause

requiring the Secretary to provide notice and an opportunity for an
expedited hearing would be redundant and nonsensical.
cannot adopt such an interpretation.
v. Dep't of Interior,

228

The Court

Conn. ex reI. Blumenthal

F.3d 82,

88

(2d Cir.

2000)

(".

[courts] are required to 'disfavor interpretations of statutes that
render
Germain,

language
503

super f 1 uous . '

U.S.

249,

253,

II )

112

(quot ing
S.

Ct.

Conn.
1146,

Na t 'I
1149

Bank

v.

(1992».

Although the Secretary's authority to make a finding of imminent

32

hazard "shall not be delegated," the fact that this finding is made
before notice or an opportunity for a hearing are provided supports
that findings pursuant to § 360b(e) (1) are made prior to a hearing.
This interpretation is further buttressed by the statutory purposes
underlying

the

360b (e) (1)

FDA,

and the

the

agency

FDCA.

tasked

Specifically,

with
the

implementing

FDA

§

"shall

promote the public health by promptly and efficiently reviewing
clinical research and taking appropriate action on the marketing of
regulated products in a timely manner;

[and] with respect to such

products, protect the public health by ensuring that .
and veterinary drugs
393 (b) (1)

(2).

responsible

for

are

safe

and effective[.]"

. human
U.S.C.

21

§

According to its statutory mandate,

the FDA is

continuously

drugs

monitoring

regulated

reviewing new studies of their effectiveness and safety.
this regulatory structure,

and
Given

it seems clear that Congress intended

the FDA to monitor approved animal drugs and issue findings when
new evidence indicates that a drug is no longer shown to be safe,
triggering the withdrawal process.
Accordingly, based on the text and grammar of
well as

the structure of

purpose of the FDA,
requires

360b (e) (1)

§

36 Ob as a

§

360b(e) (1), as

whole and the overriding

the Court finds that the plain meaning of
the

Secretary

to

issue

notice

and

§

an

opportunity for a hearing whenever he finds that a new animal drug
33

i,f Ai

is not shown to be safe.

If the drug sponsor does not meet his

burden of demonstrating that the drug is safe at the hearing, the
Secretary must issue an order withdrawing approval of the drug.
This

interpretation

interpreted 21

U.S.C.

§

is

consistent

355 (e),

the

Food & Drug Admin.

360b(e) .

with

how

courts

human drug parallel

have
to

§

Brown & Williamson Tobacco

v.

Corp., 529 U.S. 120, 134, 120 S. Ct. 1291, 1301 (2000)

("If the FDA

discovers after approval that a drug is unsafe or ineffective, it
\ shall,

after

due

notice

and

opportunity

for

applicant, withdraw approval' of the drug.")
355(e) (1)-(3»

i

(D.C. Cir. 2004)
necessarily
withdraw any

the

(quoting 21 U.S.C.

§

("[S]ection 355(e) simply sets out specific, not

exclusive,

circumstances

[human drug]

1270-71

to

Mylan Labs., Inc. v. Thompson, 389 F.3d 1272, 1281

after notice and hearing.")
1264,

hearing

(W.D.

approval
i

Okla.

under

which

FDA must

(whether final or otherwise)

Dobbs v. Wyeth Pharms.
2011)

the

( "The

FDA

I

797 F. Supp. 2d

is

statutorily

responsible for continually monitoring the safety of approved drugs
and is authorized to take actions including

l

inter alia, withdrawal

of approval if scientific data indicates the drug is unsafe.
U.S.C.

§

355(e).

[a]
omitted).

Approval must be withdrawn if the FDA finds that

drug is unsafe for use [ . ]
Although

hUman drugs,

21

§

II)

(internal quotation marks

355 (e) concerns withdrawal of FDA approval of

it contains nearly identical language to that in
34

§

360b(e),

and,

Amendments

in both the House and Senate Reports on the 1968
to

"correspond [ing] " to
(1967) i

FDCA,

the

360b(e)

§

355 (e) .

§

was

H.R.

Rep.

described
No.

90 875,

as
at 5

S. Rep. No. 90-1308, at 5 (1968).

Were the Court to conclude that

§

360b(e) (1) is ambiguous as

to when the Secretary makes findings, the Court would defer to the
agency's reasonable interpretation of the statute.
467

U.S.

at

842-43,

Ii tigation the
360b(e) (1)

360b(e} (1)
hearing.

S.

Ct.

2781-82.

FDA has maintained that

can

implementing

104

only

be

regulation,

to require

made
21

after
U.S.C.

See Chevron,

Although

in

this

findings pursuant to

a

hearing,

the

§

514.115,

interprets

the agency to make

findings

§

agency's
§

prior to a

The regulation reads: "The Commissioner shall notify in

writing the person holding [a NADA/ANADA] and afford an opportunity
for

a

hearing

[NADA/ANADA]
safe .

on

a

proposal

if he finds .

"

21 C.F.R.

§

to

withdraw

approval

of

such

. that such drug is not shown to be
514.115(b) (3) (ii).12

The plain language

of the regulation requires the Commissioner to provide notice and
an opportunity for a hearing to a drug sponsor after making a

Although § 360b(e) (1) refers to the "Secretary," defined
as the Secretary of HHS in § 321(d), the Secretary has delegated
to the Commissioner of the FDA all of the authority vested in him
pursuant to the FDCA.
(See § 1410.10 of Volume III of the FDA
Staff Manual Guides, Delegations of Authority to the Commissioner
Food and Drugs, attached as Ex. A to Barcelo Decl., ~ l(A) (1).)
12

35

finding that a drug has not been shown to be safe.
follows

that

hearing. 13

findings

are

made

by

the

It logically

Commissioner

before

a

Accordingly, if the Court were to defer to the agency's

interpretation of the statute it would reach the same conclusion:
findings pursuant to

§

360b(e) (1)

are made before a hearing and

trigger the withdrawal process.
Defendants, nevertheless, argue that the regulation does not
mean what it says.

They claim that the regulation does not refer

to the same findings as those in

§

360b(e) (1); rather, Defendants

assert that the regulation creates a different set of findings that
are based on a

lower standard than the statutory findings.

To

support this proposition, Defendants point to several notices of

13 Moreover,
this interpretation is consistent with how the
FDA has implemented § 360b(e) (1) and the accompanying regulations
in practice. The FDA consistently represents § 360b(e) (1) as
requiring notice and an opportunity for a hearing on a proposed
withdrawal whenever there is a finding that a new animal drug has
not been shown to be safe.
Findings are consistently made
pursuant to § 360b{e} (1) prior to a hearing and provide the
grounds for issuing a notice and opportunity for a hearing. See
Enrofloxacin for Poultry; Opportunity for Hearing ("Enrofloxacin
Notice"), 65 Fed. Reg. 64,954, 64,954 (Oct. 31, 2000) ("CVM is
proposing to withdraw the approval of the [NADA] for use of
enrofloxacin in poultry on the grounds that new evidence shows
that the product has not been shown to be safe as provided for in
the [FDCA] ."); Dimetridazole; Opportunity for Hearing
("Dimetridazole Notice"), 51 Fed. Reg. 45,244, 45,244 (Dec. 17,
1986) ("The [FDA], [CVM], is proposing to withdraw approval of
[NADAs] for dimetridazole.
. for use in turkeys.
This action
is based on the [CVM's] determination that the drug is not shown
to be safe for use.
.") .

36

i

proposed

withdrawals

that

rest

on

a

finding

that

there

is

a

"reasonable basis from which serious questions about the ultimate
safety

of

[the

drug"]

may

be

inferred.

See

II

Enrofloxacin

for

Poultry; Opportunity for Hearing ("Enrofloxacin Notice"), 65 Fed.
Reg. 64,954, 64,955 (Oct. 31, 2000).

Defendants maintain that this

"serious question" standard is less stringent than the "not shown
to be safe" standard in

§

360b(e) (1).

The Court is not persuaded by Defendants' argument.
al though the FDA references the

"serious question"

First,

standard in

several withdrawal notices, the regulatory standard for issuance of
any such notice is a finding that the drug is "not shown to be
safe."

See 21 C.F.R.

implementing
notices

§

§

514.115(b) (3) (ii).

In fact, the regulation

360b(e) (1) and authorizing the Commissioner to issue

describes

the

language as the statute.

requisite

findings

Compare 21 U. S. C.

in
§

exactly

the

360b (e) (1) (B)

same
("new

evidence not contained in such application or not available to the
Secretary until after such application was approved,

or tests by

new methods, or tests by methods not deemed reasonably applicable
when such application was approved,
evidence
approved,

available

to

the

evaluated together with the

Secretary when

the

application was

shows that such drug is not shown to be safe for use

under the conditions of use upon the basis of which the application
was approved") with 21 C.F.R.

§

514.115(b) (3) (ii)
37

("[n]ewevidence

not contained in such application or not available to the Secretary
until

ter such application was approved/ or tests by new methods/

or tests by methods not deemed reasonably applicable when such
application was approved,

evaluated together with the evidence

available to the secretary when the application was approved/ shows
that such drug is not shown to safe for use under the conditions of
use upon the basis of which the application was approved").
on

this

language,

incorporates
addition,

the

the

the

regulation

findings

Commissioner

unambiguously

referred

to

considers

in

the

Based

references

§

360b(e) (1).

two

findings

and
In

to

be

(Enrofloxacin Decision at 45 (" [T] he relevant

interchangeable.

statutory question is whether the animal drug 'has been shown to be
safe,'

21 U.S.C.

§

360b(e) (1),

which/

as explained earlier,

has

been interpreted to require that CVM show that there are serious
questions about the safety of [the drug]
Because

the

Court

reads

21

./1).)

C.F.R.

§

514.115 (b) (3)

unambiguously referencing the findings in 21 U.S.C.
the

Court

cannot

defer

to Defendants'

§

as

360b(e) (1),

interpretation that

the

regulation creates a different set of findings based on a different
standard.

Christensen v. Harris Cnty., 529 U.S. 576, 588/ 120

S. Ct. 1655, 1663 (2000)
regulation is

("[A]n agency's interpretation of its own

entitled to deference.

But

[such]

deference

is

warranted only when the language of the regulation is ambiguous./I)
38

(internal citations omitted); Gonzalez v.
257, 126 S. Ct. 904, 915-16 (2006)
an

agency's

interpretation

of

Oregon,

546 U.S.

243,

(refusing to apply deference to
its

own

regulation

where

the

regulation merely "parroted H the statute because "[a]n agency does
not acquire special authority to interpret its own words when,
instead of

using

regulation,

it

language. fl)
c.

its

has

expertise

and

elected merely

experience

to paraphrase

to

formulate

the

a

statutory

.14

Application: Authority of the Director of the BVM

Defendants assert that even if a finding triggers the FDA's
obligations pursuant

to

findings in this case.
the BVM,

§

360b (e) (1),

Defendants maintain that the Director of

who issued the 1977 NOOHs,

findings pursuant to

§

there have been no such

360b(e) (1).

is not authorized to make

The statute does not explicitly

authorize the Director to make findings, and Defendants therefore
argue that the Court should defer to the agency's position that the
Director
findings.

of

the

BVM

not

authorized

to

make

the

requisite

See Chevron, 467 U.S. at 842-43, 104 S. Ct. at 2781 82.

14
In any event, the 1977 NOOHs at issue in this case were
based on findings that the drug uses in question were "not shown
to be safe" and not on the "serious question" standard. And, the
Court is not called on here to determine whether the standard for
withdrawal of approval has been met. The only issue presently
before the Court is whether the withdrawal process must move
forward.

39

As discussed supra,

if a court determines that a statute is

ambiguous and that "Congress has not directly addressed the precise
question

at

issue,H

the

court

must

defer

to

an

agency's

"reasonable" interpretation of the statute it administers.
842 44, 104 S. Ct. at 2781 82.

rd. at

"[An] administrative implementation

of a particular statutory provision qualifies for Chevron deference
when it appears that Congress delegated authority to the agency
generally to make rules carrying the force

law,

and that the

agency interpretation claiming deference was promulgated in the
exercise of that authority.H
218,

226-27,

delegated

121 S.

such

Ct.

United States v. Mead Corp., 533 U.S.

2164,

authority

if

2171
it

(2001).

has

the

An

agency has been

"power

to

engage

in

adjudication or notice-and-comment rulemaking" or if there is "some
other indication of a comparable congressional intent."
227,

121 S.

Ct.

at 2171.

, at

Factors to consider when determining

whether the Chevron framework applies to an agency interpretation
include "the interstitial nature of the legal question, the related
expertise

of

the

[a] gency,

administration

of

administration,

and the

importance

statute,

the

the

the

of

the

complexity

careful consideration the

given the question over a long period of time .
Walton,

535 U.S.

212,

222,

122 S.
40

Ct.

question

1265,

that

[a] gency has
H

1272

of

to

Barnhart v.
(2002).

The

Second Circuit has been hesitant to apply Chevron deference to
nonlegislative rules issued by agencies and has Qmade clear that
\ interpretations contained in policy statements, agency manuals and
enforcement guidelines,

1 of which lack the force of law - do not

warrant Chevron style deference.'
Educ.,

412

F.3d 71,

79

II

(2d Cir.

De La Mota v.
2005)

U. S.

Dep't of

(quoting Christensen v.

Harris Cnty., 529 U.S. 576, 587, 120 S. Ct. 1655, 1662 (2000))

i

see

also Estate of Landers v. Leavitt, 545 F.3d 98, 106 (2d Cir. 2008).
Here,

§

360b(e) (1) is ambiguous as to whether the Director of

the BVM may make the requisite findings.

The text of the statute

refers to findings made by the QSecretary," which the FDCA defines
as the Secretary of HHS.
in turn,

delegated to

See 21 U.S.C.
the

§

321(d).

Commissioner of

the

The Secretary,
FDA

(See

authority vested in him pursuant to the FDCA.

1
§

of

the

1410.10 of

Volume III of the FDA Staff Manual Guides, Delegations of Authority
to the Commissioner Food and Drugs, attached as Ex. A to Barcelo
Decl.,

~

l(A) (1).)

The Commissioner, in turn, delegated authority

to the Director of the BVM to issue notices of opportunity for a
hearing on proposals
applications,

and

the

to

withdraw
authority

approval
to

issue

of

new animal

orders

withdrawing

approval when the opportunity for a hearing has been waived.
§

drug

(See

1410.503 of Volume II of the FDA Staff Manual Guides, Issuance of

Notice,

Proposals,

and Orders Relating to New Animal Drugs and
41

Medicated Feed Mill License Applications ("Staff Manual"), attached
as Ex. A to Barcelo Decl., ~ I(A) (1)-(2).)

The question before the

Court is whether the authority delegated to
the

authority

to

make

findings

discretionary duties pursuant to

that
§

Director includes

trigger

the

FDA's

non­

360b(e) (1) .

Defendants urge the Court to defer to their interpretation
that the Director does not have authority to make such findings.
Defendants argue that because the Commissioner did not delegate
authority to the Director to issue orders of withdrawal after a
hearing, the Director cannot make the findings necessary to trigger
the FDA's non discretionary duties under

§

360b(e) (1).

However,

this argument hinges on Defendants' incorrect interpretation of
360b(e) (1), whereby a finding can be made only after a hearing.
the Court reads

§

360b(e) (1)

§

As

and the accompanying regulations to

contemplate findings made prior to a hearing, Defendants'
on the Staff Manual is of no avail.

In fact,

iance

the delegations

within the Staff Manual support Plaintiffs' position that the FDA
is

legally required to re-institute withdrawal proceedings

for

penicillin and tetracyclines in animal feed.
By authorizing the Director to issue notices of an opportunity
for a hearing, the Commissioner necessarily authorized the Director
to make the findings on which such notices of withdrawal are based.
Any

notice

issued

must

"specify
42

the

grounds

upon

which"

the

proposal to withdraw is based.

21 C.F.R.

§

514.200(a).

Under both

the statute and the regulation, a proposal to withdraw may be based
on a finding that an animal drug has not been shown to be safe.
See 21 U.S.C.
practice,

360b(e) (1) (B);

21 C.F.R.

§

514.115(b) (3) (ii).

In

the Director generally states his conclusion that the

drug has not been shown to be safe and cites

§

360b(e) (1).

See

Dimetridazole; Opportunity for Hearing, 51 Fed. Reg. 45,244, 45,244
(Dec. 17, 1986)

("This [notice of intent to withdraw approval] is

being

in accordance

[issued]

Federal

Food,

Drug,

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

and

with

section 512(e) (1) (B)

Cosmetic

Act

(the

act)

(21

of

the

U.S.C.

§

That section requires FDA to withdraw approval of

an NADA if the agency finds . . . that such drug is not shown to be
[T]he Center [for Veterinary Medicine] has determined

safe

that dimetridazole is not shown to be safe for use within the
meaning

of

section

of

512 (e) (1) (B) [.] ")

Enrofloxacin Notice, 65 Fed. Reg. at 64,954

(emphasis

added);

("CVM is proposing to

withdraw the approval of the new animal drug application for use of
enrofloxacin in poultry on the grounds that new evidence shows that
the product has not been shown to be safe as provided for in the
Federal Food, Drug, and Cosmetic Act . .

• II )

(emphas i s added) .

It is clear from the FDA's own practice that the Director of the
BVM is authorized

to make

the

requisite

withdrawal proceedings pursuant to
43

§

findings

360b(e) (1).

that

trigger

Accordingly, by

explicitly

delegating

to

the

Director

the

authority

to

issue

withdrawal notices, the Commissioner delegated to the Director the
authority to make the findings that are a statutory prerequisite to
any such notice.
This conclusion is further supported by the fact that in the
event that the Director issues a notice and the drug applicant does
not request a hearing,

the Director is authorized to summarily

issue an order wi thdrawing approval.

Staff Manual

~

1 (A) (2) . )

In such cases, the findings made by the Director - and upon which
the

initial

notice

was based -

NADA under

a

sufficient basis

withdraw approval

of

Industries,

Withdrawal of Approval of

Inc.;

a

provide
§

360b(e) (1).

to

Shulcon

a New Animal Drug

Application ("Shulcon Withdrawal"), 59 Fed. Reg. 1950, 1950 (Jan.
13, 1994) ("The notice of opportunity for a hearing stated that CVM
was propos ing

to

sue an order under

approval of the NADA .

360b (e)]

[§

withdrawing

Shulcon Industries, Inc. failed to

file [a] request for a hearing.

[U]nder authority delegated

to the Commissioner of Food and Drugs

and redelegated to the

Center for Veterinary Medicine . . . notice is given that approval
of NADA 111-068 .

is hereby withdrawn.").

Although the FDA has been delegated the authority to pass
rules and regulations carrying the force of law, the agency has not
promulgated any regulation,

opinion letter,
44

or internal agency

guidance

specifying

the

limits

of

the

Director's

authority to which the Court could defer.

delegated

Moreover, in practice,

the Director routinely exercises the authority that the FDA now
claims

the

Director

lacks.

The

Court

cannot

defer

to

an

interpretation that the FDA appears to have adopted solely for
1

igation purposes.

See Bowen v. Georgetown Univ. Hosp., 488 U. S.

204, 212, 109 S. Ct. 468, 473-74 (1988)
never

applied

the

principle

of

(" [The Supreme Court] h[as]

[Chevron

deference]

to

agency

litigating positions that are wholly unsupported by regulations,
rulings, or administrative practice.").

Finally, any doubt that

the Director was authorized to issue the findings in the 1977 NOOHs
is conclusively dispelled by the Commissioner's acknowledgment and
endorsement

of

the

Director's

Penicillin

findings.

Tetracycline in Animal Feeds, 48 Fed. Reg. 4,554, 4,556

and

(Feb. 1,

1983).
2.

Findings Regarding the Subtherapeutic Use of Penicillin
and Tetracyclines

Having found that the Director of the BVM
make findings under
Director

made

§

such

authorized to

360b(e) (1), the question becomes whether the
findings

penicillin and tetracyclines.

for

the

subtherapeutic

use

In the 1977 Penicillin Notice, the

Director stated that he is

45

unaware of evidence that satisf s the requirements
for the safety of penicillin-containing premixes as
required by [§ 360b of the FDCA] and § 558.15 of the
agency's regulations.
Accordingly, he concludes, on
the basis of new information before him with respect
to these drug products, evaluated together with the
evidence available to him when they were originally
approved, that the drug products are not shown to be
safe
The evidence, in fact, indicates that
such penicillin use may be unsafe .

Penicillin Notice,
Similarly,

42

Fed.

Reg.

at

43,792

in the 1977 Tetracycline Notice,

(emphasis

added).

the Director stated

that he is

unaware of evidence that satisfies the requirements for
demonstrating
the
safety
of
extensive
use
of
subtherapeutic
tetracycline containing
premixes
established by section [360b] of the [FDCA]
Accordingly,
he
concludes,
on the basis
of new
information before him with respect to these drug
products, evaluated together with the evidence available
to him when they were originally approved, that the drug
products are safe only for the limited conditions of use
set forth [in the Notice] .

Tetracycline Notice, 42 Fed. Reg. at 56,288.
the

Penicillin

and

the

Tetracycline

Accordingly, in both

Notices,

the

Director

explicitly concluded that the drugs had not been shown to be safe
and cited

§

360b.

Such a conclusion is the statutory trigger for

the FDA to institute withdrawal proceedings, which it in fact did.
Based on the language of the 1977 Notices, the Director made the
findings necessary to trigger mandatory withdrawal proceedings for
46

the subtherapeutic uses of penicillin and tetracyclines in animal
feed.

15

Even if the Court were to adopt Defendants'

interpretation

that the Director is not authorized to make the requisite findings
under

§

legally

360b(e) (1), the Court would still conclude that the FDA is
required

Commissioner
ratifying

the

has

to
made

hold

withdrawal

the

Director's

requisite

findings.

proceedings
findings
In 1983,

by
the

because

the

noting

and

Commissioner

published a statement of policy in the Federal Register denying
several requests from drug sponsors to rescind the 1977 NOOHs, in
which the Commissioner "concurr(ed]" with the Director's findings
that the drugs had not been shown to be safe.

See Penicillin and

Tetracycline in Animal Feeds, 48 Fed. Reg. at 4,556 (explaining the
Director of BVM's decision not to rescind the 1977 NOOHs because
they "represent the Director's formal position that use of the
drugs is not shown to be safe" and stating that "(t] he Commissioner
has reviewed the Director's decision and concurs with it.").

Based

on this concurrence, the Commissioner has adopted and, therefore,
issued

findings,

and

the

§

360b(e) (1)

mandatory

withdrawal

Furthermore, during oral argument, counsel for the FDA
acknowledged that the Director lawfully issued the NOOHS in 1977
and that they were not ultra vires, indicating that the Director
has the authority to make findings sufficient to institute
withdrawal proceedings.
(See Transcript of Hearing dated Feb.
23, 2012 ("Transcript"), at 12.)
15

47

proceedings have been triggered.
III. Mootness
A.

Legal Standard

"It

has

authority

long

'to

been

give

settled

opinions

that

upon

a

moot

federal

court

questions

or

has

no

abstract

propositions, or to declare principles or rules of law which cannot
affect the matter in issue in the case before it.'

11

Church of

Scientology of Cal. v. United States, 506 U.S. 9, 12, 113 S. Ct.
447, 449 (1992)
Ct.

132, 133

(quoting Mills v. Green, 159 U.S. 651, 653, 16 S.

(1895)).

"The mootness doctrine provides that 'an

actual controversy must be extant at all stages of review,
merely at

the

time

the

complaint

is

filed.'

11

Conn.

not

Office of

Protection & Advocacy for Persons with Disabilities v. Hartford Bd.
of Educ., 464 F.3d 229, 237 (2d Cir. 2006)

(quoting British Int'l

Ins. Co. v. Seguros La Republica. S.A., 354 F.3d 120, 122 (2d Cir.
2003) ) .

"The

existence of

a

real

case

or

controversy

is

an

irreducible minimum to the jurisdiction of the federal courts."
United States v. City of New York,
1992)

972 F.2d 464, 469 70 (2d Cir.

(quoting Valley Forge Christian ColI.

v.

Ams.

United for

Separation of Church and State, 454 U.S. 464, 471, 102 S. Ct. 752,
757-58 (1982}).
pending .

Accordingly, "if an event occurs while a case is

. that makes it impossible for the court to grant any

effectual relief whatever to a prevailing party, the [case] must be
48

dismissed.

1/

Church of Scientology of Cal., 506 U. S. at 12, 113 S.

Ct. at 449 (internal quotation marks and citation omitted) .
B.

Application

Here, Defendants maintain that Plaintiffs' claim is now moot
because, during the pendency of this case, the FDA rescinded the
1977

NOOHs

for

the

subtherapeutic

tetracyclines in animal feed.

use

of

penicillin

and

See NOOH Withdrawals, 76 Fed. Reg.

79,697, 79,697 (Dec. 22, 2011).
Plaintiffs'

claim arises under

§

706 (1)

of the APA,

which

authorizes the Court to grant Plaintiffs relief if they establish
that the FDA

led to take a legally required discrete action.

Plaintiffs contend, and the Court agrees,

that upon a finding by

the FDA that a new animal drug has not been shown to be safe, the
FDA is required to withdraw approval of that drug after providing
notice and an opportunity for a hearing.

Therefore, the trigger

for FDA to initiate mandatory withdrawal proceedings is not the
issuance of a NOOH but a finding that a drug has not been shown to
be safe.

The issuance of a NOOH is simply the first step in the

mandatory withdrawal process.
entitled

to

relief

and

their

Accordingly,
claim

is

Plaintiffs are still

not

moot

if

they

can

establish that the rescission of the NOOHs did not rescind the
FDA's

findings

that

the

subtherapeutic

use

of

penicillin and

tetracyclines in animal feed has not been shown to be safe.
49

The

record makes

clear that

the

FDA did not

findings when it rescinded the 1977 NOOHs.
rescinding the 1977 NOOHs,

rescind

s

In the official not

the FDA provided three justifications

for the rescission:

(1)
FDA is engaging in other ongoing regulatory
strategies developed since the publication of the 1977
NOOHs with respect to addressing microbial food safety
issues; (2) FDA would update the NOOHs to ref
current
data, information, and pol
s if, in the future, it
decides to move forward with withdrawal of the approved
uses of the new animal drugs described in the NOOHsi and
(3)
FDA would need to prioritize any withdrawal
proceedings.

NOOH Withdrawals,

76 Fed. Reg.

79,697,

None of these reasons addresses the

79,698

(Dec.

22,

2011).

ial findings that prompted

NOOHs or suggests that the FDA is rescinding those findings.
Rather, in the notice rescinding the 1977 NOOHs, the FDA emphasized
its continuing concerns about the subtherapeutic use of penicillin
and tetracyclines.

"Although FDA is withdrawing the 1977 NOOHs,

FDA remains concerned about the issue of antimicrobial resistance.
Today's action should not be interpre
longer has

safety concerns

or

that

as a sign that FDA no

FDA will

not

consider re­

proposing withdrawal proceedings in the future, if necessary.
at 79,698.

II

This public announcement of the FDA's continuing safety

concerns and its attempts at other strategies support the view that
the FDA has not rescinded its original findings that use of the
50

drugs has not been shown to be safe. 16
In addition,

the 2010 Draft Guidance,

which represents the

FDA's current strategy to address microbial food safety issues,
emphasizes the FDA's continuing concerns about the safety of the
subtherapeutic use of penicillin and tetracyclines in animal feed.
(See Guidance No. 209, attached as Ex. B to Barcelo Decl. at 4.) In
preparing the Guidance, the FDA reviewed key scientific studies and
reports

and

available

concluded

that

to date supports

"the

overall

weight

of

evidence

the conclusion that using medically

important antimicrobial drugs for production purposes is not in the
interest of protecting and promoting the public health."
at 13.)17

The FDA has not issued a

single statement since the

16 Any claim that the 1977 NOOHs are out-of-date does not
relieve the FDA of its obligation to proceed with the withdrawal
process.
First, the agency cannot, through its own prolonged
inaction, create obstacles to its statutorily mandated
obligation.
Second, while there have been additional scientific
studies since the 1977 NOOHs were issued, they all appear to
support the FDA's original finding that the use of these drugs
has not been shown to be safe.
Finally, nothing precludes the
FDA from updating the NOOHs, so long as it does so in a
reasonably prompt manner.

17 The 2010 Draft Guidance recommends that medically
important antibiotics, including penicillin and tetracyclines, be
used "judiciously."
(See Guidance No. 209, attached as Ex. B to
Barcelo Decl. at 16.)
"In light of the risk that antimicrobial
resistance poses to public health, FDA believes the use of
medically important antimicrobial drugs in food producing animals
for production purposes (e.g., to promote growth or improve food
efficiency) represents an injudicious use of these important
drugs."
(See id. at 16.)
Strict adherence to the 2010 Draft
Guidance would not permit the subtherapeutic use of penicillin

51

issuance of the 1977 NOOHs that undermines the original findings
that the drugs have not been shown to be safe.

The FDA/s recent

decision

reiterating

to

continuing

rescind

the

concerns

subtherapeutic

uses

1977

about

NOOHs 1

the

of

while

safety

illin and

risks

posed

tetracyclines

1

its

by

the

does

not

absolve the agency of its statutory duty to initiate and complete
Am. Pub. Health Ass/n v. Veneman l 349

withdrawal proceedings.
F. Supp. 1311
withdrawal

1

1315-16 (D.D.C. 1972) (requiring the FDA to initiate

proceedings

after

announcements
conclusions

in

about

the

finding

the

Federal

efficacy

findings under 21 U.S.C.

§

that

of

355(e)1

the

Register

various

agencyl s
regarding

drugs"

"many
FDA

constituted

the human drug corollary to

§

360b(e)) .
LastlYI the fact that the FDA "is engaging in other ongoing
regulatory strategies
does

not

relieve

it

NOOH Withdrawals

1f
1

of

its

statutory

1

76 Fed. Reg. at 79 / 698
obligation

to

complete

and tetracyclines. However 1 the 2010 Draft Guidance merely
provides recommendations; there are no penalties for
ling to
adhere to the 2010 Draft Guidance. Nonetheless the Draft
Guidance makes clear that in the approval process for new
NADAs/ANADAs "products that ultimately move forward toward
approval are those products that include use conditions that are
consistent with the guidance and are intended to minimize the
extent to which the product use would contribute to [antibiot
resistance development.
(rd. at 15.) Under the FDA/s current
model therefore the NADAs/ANADAs at issue in this case would
not be approved.
1

1

1t

1

1

52

1

withdrawal proceedings.

Upon a finding that the use of a drug

under certain conditions has not been shown to be sa
prescribes

a

opportunity

clear

for

a

course

hearing,

of

conduct:

and,

if

issue

the

drug

,§360b(e} (1)
not

and

sponsor does

demonstrate that the drug use is safe at the hearing,
approval of such use. 1S
choose

a

different

proceedings,

an
not

withdraw

The statute does not empower the agency to

course

of

action

in

lieu

of

withdrawal

such as that embodied in the 2010 Draft Guidance.

Pub. Citizen. Inc. v. Nat'l Highway Traffic Safety Admin., 374
F.3d 1251, 1261 (D.C. Cir. 2004)

("[A]n agency ordered by Congress

to promulgate binding regulatory requirements may not issue a non­
binding
action.")

icy

statement

that

encourages

but

does

not

compel

(citing Pub. Citizen v. Nuclear'Regulatory Comm'n,

F.2d 147, 157 (D.C. Cir. 1990))

i

901

Natural Res. Def. Council. Inc. v.

Envtl. Prot. Agency, 595 F. Supp. 1255, 1261 (S.D.N.Y. 1984)

("The

agency charged with implementing the statute is not free to evade
the unambiguous directions of the law merely for administrative
convenience.")

(internal quotation marks and citations omitted).

Accordingly, because the rescission
rescind

the

original

findings

that

the

the 1977 NOOHs did not
subtherapeutic

use

of

Of course, if the drug sponsors demonstrate that the use
of the drug is safe, then the Commissioner cannot withdraw
approval.
18

53

penicillin and tetracyclines in food producing animals has not been
shown to be safe, Plaintiffs' claim is not moot.
CONCLUSION

For the

foregoing reasons,

Plaintiffs'

Judgment on their first claim for rel
Motion for Summary Judgment
ordered

to

initiate

Specifically,

NADAs / ANADAs .
Director

of

the

CVM

must

f is granted and Defendants'

is denied.

withdrawal

Motion for Summary

Defendants are hereby

proceedings

for

the

relevant

the Commissioner of the FDA or the
re issue

a

notice

of

the

proposed

withdrawals (which may be updated) and provide an opportunity for
a hearing to the relevant drug sponsors; if drug sponsors timely
request hearings and raise a genuine and substantial issue of fact,
the

FDA must

hold a

public

If,

evidentiary hearing.

hearing, the drug sponsors fail to show that

at

the

use of the drugs

is safe, the Commissioner must issue a withdrawal order.
The Court notes the limits of this decision.
Court

is

ordering

the
the

proceedings

FDA

to

complete

relevant

Although the

mandatory

penicillin

and

withdrawal
tetracycline

NADAs/ANADAs, the Court is not ordering a particular outcome as to
the final issuance of a withdrawal order.
demonstrate
tetracyclines

that
is

the
safe,

subtherapeutic
then

the

54

use

If the drug sponsors
of

penicillin

Commissioner

cannot

and/or

withdraw

approval. 19
So Ordered.

THEODORE H. KATZ
UNITED STATES MAGISTRATE

Dated: March 22, 2012

New York, New York

19 At oral argument,
both parties agreed that additional
briefing is necessary on the issue of a time-l
for holding a
hearing and issuing a final decision in the matter.
Transcript at 10.)

55