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

Filing 103

MEMORANDUM AND ORDER re: 79 MOTION to Strike Document No. (78-6). MOTION to Strike Document No. (78-6), 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. For the reasons set forth, the plaintiffs' motion to strike (Docket no. 79) is granted in part, and Document no. 78-6 is stricken from the record. The Government's motion for a stay pending appeal, or, in the alternative, for an interim stay pending resolution of the Government's planned application for a stay in the Second Circuit (Docket no. 92), is denied. Furthermore, the Government is ordered to comply with the Court's order of March 22, 2012, according to the schedule included in paragraphs 11 through 25 of the Declaration of William T. Flynn dated May 15, 2012 (Docket no. 86). (Signed by Magistrate Judge James C. Francis on 8/8/2012) Copies Mailed By Chambers. (ja)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
- - - - - - - - - - - - - - - - - -:
NATURAL RESOURCES DEFENSE COUNCIL, :
CENTER FOR SCIENCE IN THE PUBLIC
:
INTEREST, FOOD ANIMAL CONCERNS
:
TRUST, PUBLIC CITIZEN, INC., and
:
UNION OF CONCERNED SCIENTISTS,
:
INC.,
:
:
Plaintiffs,
:
:
- against :
:
UNITED STATES FOOD AND DRUG
:
ADMINISTRATION, MARGARET HAMBURG, :
in her official capacity as
:
Commissioner, United States Food
:
and Drug Administration, CENTER
:
FOR VETERINARY MEDICINE, BERNADETTE:
DUNHAM, in her official capacity as:
Director, Center for Veterinary
:
Medicine, UNITED STATES DEPARTMENT :
OF HEALTH AND HUMAN SERVICES, and :
KATHLEEN SIBELIUS, in her official :
capacity as Secretary, United
:
States Department of Health and
:
Human Services,
:
:
Defendants.
:
- - - - - - - - - - - - - - - - - -:
JAMES C. FRANCIS IV
UNITED STATES MAGISTRATE JUDGE

(ECF)
11 Civ. 3562 (JCF)
MEMORANDUM
AND ORDER

Plaintiffs Natural Resources Defense Council, Inc. (“NRDC”),
Center for Science in the Public Interest, Food Animal Concerns
Trust, Public Citizen, and Union of Concerned Scientists brought
this action against the various government defendants seeking to
compel the United States Food and Drug Administration (the “FDA”)
to initiate proceedings to withdraw its approval of the use of
certain antibiotics in livestock for non-therapeutic purposes.1

1

For convenience, I will refer to the plaintiffs collectively
as “NRDC” and the defendants collectively as the Government, unless
1

(Memorandum Opinion and Order dated March 22, 2012, at 2 (“March 22
Order”)).

The

parties

consented

to

the

jurisdiction

of

a

magistrate judge, and on March 22, 2012, the Honorable Theodore H.
Katz, U.S.M.J., granted the plaintiffs’ motion for summary judgment
and denied the defendants’ motion for summary judgment on the
plaintiffs’ first claim for relief, which charged the defendants
with violating the Administrative Procedure Act (the “APA”), 5
U.S.C. § 706(2), and the Food, Drug, and Cosmetic Act (the “FDCA”),
21 U.S.C. § 360b(e), for failing to implement such
(March 22 Order at 1, 54).

proceedings.

On June 1, 2012, Judge Katz issued an

opinion granting the plaintiffs’ motion for summary judgment and
denying

the

defendants’

motion

for

summary

judgment

on

the

plaintiffs’ third claim for relief, which alleged that the FDA
violated

the

same

two

statutes

when

it

denied

two

citizen

petitions2 “request[ing] that the FDA begin withdrawal proceedings
for all non-therapeutic uses of medically-important antibiotics in
food-producing animals.” (Memorandum Opinion and Order dated June
1, 2012 (“June 1 Order”), at 2, 9).
The March 22 Order requested additional briefing on the issue
of a schedule under which the FDA must act.
n.19).

(March 22 Order at 55

In the midst of that briefing, the Government appealed the

March 22 Order (Notice of Appeal dated May 21, 2012) and filed a

otherwise necessary for clarity.
2

FDA regulations authorize the agency to consider petitions
submitted by members of the public (including organizations)
“request[ing] the Commissioner [of the FDA] to take or refrain from
taking” administrative action. 21 C.F.R. § 10.30.
2

motion requesting that this Court stay the March 22 Order pending
resolution of the appeal or, in the alternative, impose an interim
stay pending disposition of the Government’s not-yet-filed stay
application in the United States Court of Appeals for the Second
Circuit (Memorandum of Law in Support of the Government’s Motion
for a Stay Pending Appeal (“Gov’t Stay Memo.”) at 1).

The

plaintiffs, for their part, filed a motion to strike documents that
the Government submitted in connection with its motion for summary
judgment on the third claim for relief.

(Plaintiffs’ Motion to

Strike Non-Record Material (“Motion to Strike”)).
Upon Judge Katz’ retirement, this case was reassigned to me.
Before me now, then, are the parties’ briefs regarding timing, the
Government’s motion for a stay, and the plaintiffs’ motion to
strike, and I held oral argument on these issues on July 18, 2012.
For the reasons that follow, the plaintiffs’ motion to strike is
granted in part; the Government’s proposed schedule for compliance
with the March 22 Order is adopted; and the Government’s motion for
a stay is denied.
Background
The facts of the case are set out in the March 22 and June 1
Orders, with which I assume familiarity.
background

will

be

helpful

in

Nevertheless, some

understanding

the

following

discussion.
In the 1950s, the FDA approved the use of antibiotics “to
stimulate growth and promote feed efficiency in food-producing
animals” and issued permissions (by approving new animal drug
3

applications or abbreviated new animal drug applications) for
penicillin and tetracyclines to be used for such purposes.
22 Order at 4-6).

(March

By the mid-1970s, however, the FDA, concerned

with the public health risk to humans and animals of antibiotic
resistance caused by such uses, issued a regulation “providing that
the

agency

therapeutic]

would
uses

propose
of

to

withdraw

antibiotics

in

approval

animal

of

feed

all

[non-

unless

drug

sponsors and other interested parties” presented data resolving the
agency’s concerns. (March 22 Order at 6-8). Thereafter, the FDA’s
Bureau of Veterinary Medicine (the “BVM”) (which has since been
renamed the Center for Veterinary Medicine (the “CVM”)), along with
a subcommittee of the FDA’s National Advisory Food and Drug
Committee (the “NAFDC”) reviewed the data submitted.
Order at 8-9 & n.5).

(March 22

In 1977, the NAFDC adopted the report and

recommendations of its subcommittee, which advised the FDA to
“withdraw approval for the [non-therapeutic] uses of penicillin”
and “discontinue the[] use [of tetracyclines] for growth promotion
and/or feed efficiency in all animal species for which effective
substitutes are available.”

(March 22 Order at 9-10 (internal

quotation marks omitted)).
Later in 1977, after review of the NAFDC recommendations, the
Director of the BVM issued notices of an opportunity for hearing
(“NOOHs”) on proposals to withdraw approval of all non-therapeutic
uses of penicillin in animal feed and most non-therapeutic uses of
tetracyclines in animal feed.

(March 22 Order at 10).

The FDA

issued the NOOHs pursuant to a subsection of the provision of the
4

FDCA governing “New Animal Drugs”:
The Secretary [of the Department of Health and Human
Services] 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 . . . 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 . . . .
21 U.S.C. 360b(e)(1)(B).
firms,

agricultural

In response, “approximately twenty drug

organizations,

and

individuals

requested

hearings,” at which, pursuant to the statutory and regulatory
scheme, they would have the burden of proving that the relevant
uses of the drugs were safe.

(March 22 Order at 12).

The Commissioner of the FDA granted the hearing requests, but
no hearings were ever scheduled.

(March 22 Order at 12-13).

Instead, the FDA continued to research the risks connected with the
non-therapeutic uses of antibiotics in the feed of food-producing
animals, contracting with various agencies to study the problem.
(March 22 Order at 13-15).

Three reports released in the 1980s --

by the National Academy of Sciences, the Seattle-King County
Department of Public Health, and the Institute of Medicine -- were
unable to conclude that the non-therapeutic use of antibiotics in
animal feed was safe, instead finding support for the FDA’s
concerns.

(March 22 Order at 14-15).

In June 2010, the FDA released a non-binding Draft Guidance,
which reviewed recent studies on the risks of non-therapeutic uses
5

of antibiotics in animal feed and concluded that the evidence
supported

the

conclusion

“that

using

medically

important

[antibiotic] drugs for production purposes is not in the interest
of protecting and promoting the public health.” (March 22 Order at
16-17 (internal quotation marks omitted)).

The FDA recommended

restricting the use of antibiotics in food-producing animals to
uses necessary for ensuring medical health and uses including
veterinary oversight or consultation.

(March 22 Order at 17).

The plaintiffs filed this action in May 2011 “alleging that
the FDA’s failure to withdraw approval of the [non-therapeutic] use
of

penicillin

and

tetracyclines

pursuant

to

the

1977

NOOHs

constituted an agency action unlawfully withheld or unreasonably
delayed in violation” of the APA and the FDCA.
18).

In

December

2011,

the

FDA

rescinded

(March 22 Order at
the

1977

NOOHs,

explaining that it continued to be concerned about antibiotic
resistance,

but

that

it

was

“engaging

in

other

regulatory

strategies . . . and that if [it] were to move forward with the
NOOHs it would need to update [them] to reflect current data,
information,
proceedings.”
omitted)).

and

policies

and

prioritize

any

withdrawal

(March 22 Order at 17 (internal quotation marks

In February 2012, the plaintiffs filed a supplemental

complaint against the defendants contending that the FDA had
violated the APA and the FDCA when it denied two citizen petitions
submitted by certain plaintiffs and non-parties (one in 1995 by
Center for Science in the Public Interest, Food Animal Concerns
Trust, Public Citizen, Union of Concerned Scientists, and non-party
6

Environmental Defense Fund; one in 2005 by Union of Concerned
Scientists and non-parties Environmental Defense Fund, American
Academy of Pediatrics, and American Public Health Association).
(June 1 Order at 2, 9, 14-15).
In

the

March

22

Order,

Judge

Katz

held,

first,

that

§

360b(e)(1) and its accompanying regulations require the FDA to take
a series of “discrete actions” upon a “finding” that a new animal
drug has not been shown to be safe, thus bringing this case under
the rubric of § 706(1) of the APA, which the Supreme Court has held
applies only when “an agency failed to take a discrete action that
it is required to take.”

Norton v. Southern Utah Wilderness

Alliance, 542 U.S. 55, 64 (2004); (March 22 Order at 21-26).

He

then held that the FDCA unambiguously requires the Secretary of
Health and Human Services to begin proceedings to withdraw approval
of a drug by issuing notice and providing an opportunity for a
hearing once “[s]he finds that a new animal drug is not shown to be
safe,” rejecting the Government’s position that the “finding” that
triggers mandatory withdrawal proceedings occurs only after the
opportunity for a hearing.

(March 22 Order at 27-39).

As a

consequence of the conclusion that the statute’s meaning is plain,
the

opinion

unsurprisingly

holds

that

the

FDA’s

contrary

interpretation does not deserve deference under Chevron, U.S.A.,
Inc. v. Natural Resources Defense Council, 467 U.S. 837 (1984), and
its progeny.

(March 22 Order at 35-39).

Moreover, Judge Katz

found that (1) the Commissioner of the FDA, who has been delegated
with

the

authority

vested

in

the
7

Secretary

under

the

FDCA,

authorized the Director of the BVM “to make the findings on which
such notices of withdrawal are based” (March 22 Order at 41-42);
(2) in the 1977 NOOHs, the Director of the BVM made such findings
requiring the FDA to proceed with the withdrawal of penicillin and
tetracyclines (March 22 Order at 45-46); and (3) these findings
were later adopted by Commissioner (March 22 Order at 47-48).

The

March 22 Order therefore held that the Government violated the APA
and the FDCA by failing to begin the withdrawal of approval for
non-therapeutic uses of penicillin and tetracyclines in animal feed
after it had made the findings resulting in the NOOHs.

In

addition, Judge Katz held that, because the Government’s duty was
triggered by the Director’s findings, and not by the issuance of
the NOOHs, the 2011 rescission of the NOOHs did not moot this
claim.

(March 22 Order at 48-53).

The June 1 Order rejected the Government’s argument that the
FDA’s denials of the citizen petitions were unreviewable “decisions
not to enforce,” Heckler v. Chaney, 470 U.S. 821, 827 (1985), and
held that the denials were judicially reviewable because they were
not “‘action[s] committed to agency discretion by law’” pursuant to
the APA.

(June 1 Order at 25 (quoting 5 U.S.C. § 701(a)(2)).

Specifically, Judge Katz found that “[t]he process of withdrawing
approval of a new animal drug is more analogous to informal
rulemaking than to traditional enforcement actions,” and thus was
amenable to judicial review under Massachusetts v. EPA, 549 U.S.
497 (2007).

(June 1 Order at 31 & n.17).

In addition, he found

that the guiding statute, the FDCA, “provides sufficient guidelines
8

for the agency to follow in exercising its enforcement powers to
rebut” any presumption of unreviewability.

(June 1 Order at 35).

Reviewing the denials, the June 1 Order found the FDA’s asserted
reasons -- that engaging in the formal withdrawal process would be
too time-consuming and expensive, and that the phase-out of nontherapeutic

uses

of

medically-important

antibiotics

would

be

accomplished through a non-binding voluntary guidance program begun
in 2009 -- arbitrary and capricious because they did not follow the
clear commands of the FDCA.

(June 1 Order at 40-52).

The Court

therefore held that the denials must be vacated under Section
706(2)(A) of the APA, which authorizes a court to set aside
arbitrary and capricious agency action.

(June 1 Order at 38-40,

52-53).
Discussion
A.

Motion to Strike

The plaintiffs ask that the Court strike a statement issued by
the Animal Health Institute (“AHI”)3 expressing general support for
the FDA’s plans to reduce the non-therapeutic use of medicallyimportant antibiotics in animal feed through a voluntary guidance
program because the document is not part of the administrative
record that was before the FDA when the challenged decisions were
taken.4

(Motion to Strike at 1-2; AHI Statement on FDA Guidance

3

AHI is an industry organization representing companies that
develop and produce animal drugs. See Animal Health Institute,
About AHI, available at http://www.ahi.org/about/ (last visited
Aug. 2, 2012).
4

Although summary judgment has already been granted to the
plaintiffs on the claim in connection with which this document was
9

Documents dated April 11, 2012 (“AHI Statement”), attached as Exh.
F to Third Declaration of Amy A. Barcelo dated April 16, 2012 (“3d
Barcelo Decl.”)).
The “focal point” of judicial review of agency action is the
administrative record upon which the agency made its decision, “not
some new record made initially in the reviewing court.”

Camp v.

Pitts, 411 U.S. 138, 142 (1973); IMS, P.C. v. Alvarez, 129 F.3d
618, 623 (D.C. Cir. 1997) (“It is a widely accepted principle of
administrative law that the courts base their review of an agency’s
actions on the materials that were before the agency at the time
its decision was made.”); New York v. Shalala, No. 93 Civ. 1330,
1996

WL

87240,

at

*5

(S.D.N.Y.

Feb.

29,

1996)

(“Shalala”)

(“Judicial review of agency action is generally limited to review
of the full administrative record that was before the agency at the
time it rendered its decision.”).

Thus, it is established that a

court may strike documents from the record that were not before the
agency at the time of its decision.5

See, e.g., Environmental

submitted and it is clear that Judge Katz did not rely on this
document in deciding that motion, the dispute is not moot, because
its resolution will affect the composition of the record on appeal.
5

Contrary to the Government’s apparent position that Rule
12(f) of the Federal Rules of Civil Procedure grants a court its
only power to strike documents from the record and that such
documents are limited by the rule to “pleadings” (Memorandum in
Opposition to Plaintiffs’ Motion to Strike Non-Record Material
(“Strike Opp. Memo.”) at 1), a court has “‘inherent authority to
strike any filed paper which it determines to be abusive or
otherwise improper under the circumstances.’” In re Bear Stearns
Cos., Inc., Securities, Derivative, and ERISA Litigation, 763 F.
Supp. 2d 423, 581 (S.D.N.Y. 2011) (quoting Sierra v. United States,
No. 97 Civ. 9329, 1998 WL 559715, at *9 (S.D.N.Y. Sept. 10, 1998));
see also, e.g., Jenkins v. City of New York, No. 91 Civ. 3639, 1992
WL 147647, at *3-4 (S.D.N.Y. June 15, 1992) (striking affidavit
10

Defense Fund, Inc. v. Costle, 657 F.2d 275, 285-86 (D.C. Cir. 1981)
(affirming district court’s decision to strike affidavits that were
not part of administrative record); Shalala, 1996 WL 87240, at *5-7
(striking materials outside administrative record from dispositive
motion papers).
The Government contends that the AHI Statement is properly
included

as

“background

information

about

the

animal

drug

industry’s current stance toward the FDA’s plans to regulate.”
(Strike Opp. Memo. at 2).

Some courts have held that information

outside of the administrative record may be reviewed as background
to

help

the

court

Rochester-Genesee

understand
Regional

the

relevant

Transportation

issues.
Authority

See
v.

Hynes-Cherin, 531 F. Supp. 2d 494, 518 (W.D.N.Y. 2008) (collecting
cases from the Sixth and Ninth Circuits, the District of the
District of Columbia, and the Western District of New York).
According to the defendants, the AHI Statement shows that the
animal drug industry “appears now to support the FDA’s approach.”6
(Strike Opp. Memo. at 2).
However, the Government has not explained how an expression of
support from the animal drug industry that post-dates the FDA’s

opposing summary judgment as improper).
6

This characterization overreaches. The AHI Statement merely
expresses “agree[ment]” with the “direction and the collaborative,
stakeholder process” as a prelude to a complaint that “there are
details that must be addressed to make this approach practical and
workable.” (AHI Statement at 1). Indeed, as Judge Katz pointed
out, the Government provides “no hard evidence that the drug
sponsors have agreed or will agree[] to the proposed measures.”
(June 1 Order at 49-50).
11

decision on the citizen petitions is relevant -- even as background
-- to the question of whether the FDA’s denial violated the FDCA or
the APA.

To be sure, the AHI Statement could be used as evidence

that the FDA’s voluntary compliance program might succeed (although
as noted in the footnote, this is something of a stretch), but the
Government has expressly disavowed the notion that the FDA’s
confidence in the program is relevant to its defenses, stating that
the premise that the Court’s determination might “depend[] on the
strength of the FDA’s asserted faith or professed confidence in the
voluntary compliance program” is “incorrect.”

(Strike Opp. Memo.

at 2 (internal quotation marks and ellipses omitted)).

Indeed, at

oral argument, the Government admitted that AHI’s public statements
“have very little relevance” to the FDA’s decisions. (Tr. at 13).
Moreover, it is clear that Judge Katz did not find the AHI
Statement useful or relevant, as he never alluded to it in the June
1 Order.
Because the AHI Statement was not part of the administrative
record before the FDA at the relevant time and it is not “useful”
to the Court as background information, the plaintiffs’ motion to
strike is granted to the extent that it requests that the AHI
Statement be stricken from the record.
The plaintiffs also asked the Court to disregard three other
documents submitted with the Government’s motion papers.

(Motion

to Strike at 3; FDA Draft Guidance for Industry #209 dated April
13, 2012 (“Draft Guidance #209”), attached as Exh. A to 3d Barcelo
Decl.; Draft Text for Proposed Regulation dated April 5, 2012
12

(“Draft Regulation”), attached as Exh. B to 3d Barcelo Decl.; FDA
Guidance for Industry #213 dated April 13, 2012 (“Draft Guidance
#213”), attached as Exh. C to 3d Barcelo Decl.).7

NRDC has since

conceded that the documents were properly part of the record, and
it is, therefore, no longer pressing this claim.

(Transcript of

Oral Argument dated July 18, 2012 (“Tr.”) at 5-6).
B.

Schedule for Withdrawal Proceedings

In compliance with the March 22 Order, the parties have
submitted

briefs

on

the

withdrawal proceedings.
imposing

any

deadlines,

issue

of

a

schedule

for

the

FDA’s

The Government asks that I refrain from
stating

that

“subject

to

any

future

direction by the appellate courts, it intends to abide by the
orders of the Court.”

(Brief in Support of the Government’s

Position on the Issue of Timing (“Gov’t Timing Br.”) at 1-2).

In

the alternative, the Government proposes a timeline -- derived from
an “analysis to estimate the time and resources that would be
required” (1st Flynn Decl., ¶ 6) -- that requires reissuance of the
NOOHs within 11 to 17 months, with an additional period of years to
complete the withdrawal process, including administrative appeals.
(Gov’t Timing Br. at 10-11; 1st Flynn Decl., ¶¶ 6, 11-15, 18-21,
23-24).

NRDC, in contrast, asserts that a schedule is essential,

and that the Government’s “protracted” timing estimate should be
slashed so that the NOOHs are required to be issued within 125 days
of commencement of the process and withdrawal proceedings are
7

The Third Barcelo Declaration mistakenly states that Draft
Guidance #213 is attached as Exhibit B and that the Draft
Regulation is attached as Exhibit C. (3d Barcelo Decl., ¶¶ 4-5).
13

complete in an additional two years.

(Plaintiffs’ Opposition to

the Government’s Brief Concerning a Schedule for Compliance with
the Court’s Order (“Pl. Timing Br.”) at 21, 24).
1.

Authority to Impose a Schedule

Even in the area of administrative law, district courts have
“broad equitable powers” to order “any appropriate relief” that is
not prohibited by Congress.
(D.C. Cir. 2001).

Cobell v. Norton, 240 F.3d 1081, 1108

However, a court must be careful not to intrude

“into the domain which Congress has set aside exclusively for the
administrative

agency,”

Federal

Power

Commission

v.

Transcontinental Gas Pipe Line Corp., 423 U.S. 326, 333 (1976)
(internal

quotation

marks

omitted),

by

“control[ling]

the

operations” of the agency, Sierra Club v. U.S. Army Corps of
Engineers, 701 F.2d 1011, 1042 (2d Cir. 1983). For example, in the
absence of “extremely compelling circumstances,” a court oversteps
its bounds if it dictates the procedures an agency must follow in
performing its statutory duties, see Vermont Yankee Nuclear Power
Corp. v. Natural Resources Defense Council, 435 U.S. 519, 543-45
(1978); or retains jurisdiction to oversee an agency’s compliance
with the court’s orders, see Sierra Club, 701 F.2d at 1042-49
(vacating district court’s order appointing special master with
“highly intrusive” mandate and requiring agency itself to make
required investigations and analyses, among other things); Baystate
Medical Center v. Leavitt, 587 F. Supp. 2d 37, 41 (D.D.C. 2008)
(refusing to retain jurisdiction to oversee agency’s compliance
with court order).

However, it is clear that if an agency has
14

unreasonably delayed dispatching its duty, it is permissible for a
court to impose a timetable for compliance.

See Cobell, 240 F.3d

at 1107 (affirming district court’s order imposing timetable when
agency

had

unreasonably

delayed

fulfilling

its

duty);

Public

Citizen Health Research Group v. Brock, 823 F.2d 626, 627 (D.C.
Cir. 1987) (per curiam) (noting that court ordered agency that had
unreasonably delayed rulemaking to complete proceedings within one
year);

White

(affirming
Security

v.

Matthews,

district

559

court

Administration

F.2d

order

because

852,

imposing
of

860

(2d

Cir.

1977)

on

Social

schedule

unreasonable

delays

in

adjudicating claims).
The Government asserts that this is not a situation in which
the FDA has unreasonably delayed action.

(Gov’t Timing Br. at 1;

Reply Brief on Support of the Government’s Position on Timing
(“Gov’t Timing Reply”) at 6).

It is true that NRDC did not argue

that the FDA’s failure to complete withdrawal proceedings was
action “unreasonably delayed” under the APA, but rather that it was
“unlawfully

withheld.”

(Memorandum

of

Law

in

Plaintiffs’ Motion for Summary Judgment at 10-13).

Support

of

In granting

NRDC’s motion for summary judgment, Judge Katz did not make an
explicit

finding

that

the

FDA

However,

he

mark

the

agency’s

repeatedly

did

referred

to

withdrawal proceedings.

its

unreasonably

delayed

“prolonged

decades-long

action.

inaction”

failure

to

and

commence

(March 22 Order at 2-3, 17, 51 n.16).

Similarly, in its brief regarding timing, NRDC focuses on the
agency’s delay.

(Pl. Timing Br. at 2, 8, 10-11).
15

The fact that

the March 22 Order lacks a discussion of unreasonable delay does
not indicate, as the Government would have it, that it is “[not]
present here” as a factual matter.

(Gov’t Timing Reply at 6).

Nor

does it mean that I cannot consider the whether the agency has in
fact unreasonably delayed institution of withdrawal proceedings in
deciding how to exercise the court’s “broad equitable powers” to
order relief.
To decide whether there has been unreasonable delay meriting
the imposition of a schedule or deadline, I am guided by “six
principles that have helped courts determine when mandamus is an
appropriate remedy for agency delay”:
(1) the time agencies take to make decisions must be
governed by a “rule of reason”; (2) where Congress has
provided a timetable or other indication of the speed
with which it expects the agency to proceed in the
enabling statute, that statutory scheme may supply
content for this rule of reason; (3) delays that might be
reasonable in the sphere of economic regulation are less
tolerable when human health and welfare are at stake; (4)
the court should consider the effect of expediting
delayed action on agency activities of a higher or
competing priority; (5) the court should also take into
account the nature and extent of the interests prejudiced
by the delay; and (6) the court need not find any
impropriety lurking behind agency lassitude in order to
hold that agency action is unreasonably delayed.8
In re Barr Laboratories, Inc., 930 F.2d 72, 74-75 (D.C. Cir. 1991)
(internal

quotation

marks

omitted)

(citing

Telecommunications

Research & Action Center v. FCC, 750 F.2d 70, 80 (D.C. Cir. 1984)).
“[A] finding that delay is unreasonable does not, alone, justify

8

At oral argument, the Government requested additional
briefing on the unreasonable delay factors, as they were not
addressed in the initial round of papers. (Tr. at 62). Further
briefing, however, is unnecessary and would only create more delay.
16

intervention.”

Barr

Laboratories,

930

F.2d

at

75

(internal

quotation marks omitted). Instead, a court should weigh the effect
on the agency of the contemplated order, as well as the effect of
the delay on other interests involved.
As the March 22 Order makes clear, the finding that triggered
the FDA’s duty to commence withdrawal proceedings was memorialized
in the 1977 NOOHs. This lawsuit was filed over thirty years later,
in 2011.

During the intervening decades, the FDA did not perform

its statutorily-prescribed duty to initiate, let alone complete,
withdrawal

proceedings.

Although

Congress

has

not

provided

guidance on the issue, I have no difficulty concluding that thirtyplus years is an unreasonable delay.
The

Government

complains

that

imposing

a

timetable

will

impermissibly re-order its priorities, citing Barr Laboratories.
In that case, a drug manufacturer sought a writ of mandamus
compelling the FDA to act on its generic drug applications.
Laboratories, 930 F.2d at 73.

Barr

Although the law required action

within 180 days of receipt of the applications, the FDA admitted
that action on such applications took significantly longer and
estimated that in the future, it could take almost two years.
at

74.

Nonetheless,

the

court

refused

to

issue

the

Id.

writ,

explaining that “a judicial order putting Barr at the head of the
queue simply moves all others back one space and produces no net
gain.”

Id. at 75.

This case is easily distinguishable.

In Barr Laboratories,

the writ of mandamus would have effectively controlled the agency’s
17

generic drug approval process, benefitting one enterprise at the
expense of others, failing to improve the efficiency of the process
of approving (or disapproving) generic drugs, and having no effect
on human health and welfare.
its

duty

proceedings.

to

initiate

Here, the FDA has utterly failed in
congressionally-mandated

withdrawal

Requiring it to do so promptly is not reordering the

FDA’s priorities; it is correcting the agency’s misprision of its
duty.

In Barr Laboratories, the court found that the contemplated

order would have no effect on human health and welfare.

Here, in

contrast, compelling the FDA to timely fulfill its obligations will
speed adjudication on the issue of whether the non-therapeutic use
of certain antibiotics in animal feed threatens human health and,
if the sponsors or other interested parties cannot demonstrate the
drugs’ safety, accelerate their compulsory withdrawal.

See 21

U.S.C. § 360b(e)(1) (mandating withdrawal proceedings when the
evidence demonstrates that the “drug is not shown to be safe”); 21
C.F.R. § 514.115(b)(3) (same); Tetracycline (Chlortetracycline and
Oxytetracycline)-Containing Premixes; Opportunity for Hearing, 42
Fed. Reg. 56264 (Oct. 21, 1977) (stating that “the tetracyclinecontaining products have not been shown to be safe for widespread
subtherapeutic use”); Penicillin-Containing Premixes; Opportunity
for Hearing, 42 Fed. Reg. 43772 (Aug. 30, 1977) (stating that “the
penicillin-containing products have not been shown to be safe for
subtherapeutic use”).
The Government repeatedly asserts that a schedule should not
Gov’t Timing Br. be imposed because the FDA did not believe it had
18

“a legal duty to proceed with hearings.”

(Gov’t Timing Br. at 1,

5, 8; Gov’t Timing Reply at 2; Declaration of William T. Flynn
dated May 15, 2012 (“1st Flynn Decl.”), ¶ 5).

However, as the

District of Columbia Circuit makes clear, “the court need not find
any impropriety lurking behind agency lassitude in order to hold
that agency action is unreasonably delayed.”
930 F.2d at 75.

Barr Laboratories,

The FDA’s asserted belief that neither the FDCA

nor its regulations required further action once the 1977 NOOHs
were issued, then, does not make this delay any less unreasonable.
Moreover, the FDA seems to have a pattern of attempting to avoid
instituting proceedings to withdraw approval of the non-therapeutic
use of antibiotics in animal feed.

As detailed in the June 1

Order, in 1999 and 2005 certain plaintiffs (as well as other
entities)

filed

proceedings.
action

on

citizen

petitions

with

(June 1 Order at 9, 14-15).
the

respectively.”

petitions

for

the

seeking

such

The FDA delayed final

“thirteen

(June 1 Order at 45).

FDA

and

seven

years,

It was not until November 7,

2011, during the pendency of this litigation, that the agency
issued final responses denying the petitions, citing the time and
expense of holding withdrawal proceedings. (June 1 Order at 12-13,
19-20, 44).

As Judge Katz held, “the fact that withdrawing

approval may be costly or time-consuming is not a sufficient
justification . . . for the [FDA] to abdicate its duty . . . .”9
9

Judge Katz also noted that there was “some justification”
for the plaintiffs’ hypothesis that the FDA’s “refusal to evaluate
the science [included in the citizen petitions] was motivated in
part by a desire to avoid the statutory requirement of initiating
formal withdrawal proceedings.” (June 1 Order at 48).
19

(June 1 Order at 45).

In these circumstances, I find that the

FDA’s unreasonable delay merits the imposition of a schedule for
compliance with the March 22 Order.10
2.

Schedule for Compliance

The Government has conducted an analysis to determine the
likely amount of time it will take to perform each of the tasks
required to comply with the March 22 Order and supports the
schedule with a declaration from Dr. William T. Flynn, the CVM’s
Deputy Director for Science Policy. (1st Flynn Decl., ¶¶ 1, 6, 1115, 18-21, 23-24).

NRDC objects to the proposed time estimates as

“protracted” (Pl. Timing Br. at 1), “leisurely” (Pl. Timing Br. at
14), “vague” (Pl. Timing Br. at 14, 16), “excessive” (Pl. Timing
Br. at 14, 18), and “generous” (Pl. Timing Br. at 15), and suggests
a significantly abbreviated schedule (Pl. Timing Br. at 21). While
the

Government’s

position

draws

on

its

expertise,

including

experience with prior withdrawal proceedings (Gov’t Timing Br. at
13; 1st Flynn Decl., ¶ 23; Declaration of William T. Flynn dated
June 1, 2012 (“2d Flynn Decl.”), ¶ 4; Tr. at 57), the plaintiffs’
arguments are largely speculative.
Look, for example, at the plaintiffs’ complaints about the
amount of time it will take for the agency to search CVM’s files
for information relevant to reissuance of the NOOHs.

Dr. Flynn

estimates it will take “10 to 14 employees . . . approximately 60
10

Importantly, the imposition of this schedule does not
involve the court retaining jurisdiction over the case or requiring
periodic reports on compliance from the FDA.
Thus, it differs
significantly from the court orders at issue in Sierra Club and
Vermont Yankee.
20

days,” with each employee devoting “a substantial amount of time”
to the project.

(1st Flynn Decl., ¶ 11).

NRDC argues that,

because Dr. Flynn does not specify the amount of time each employee
will spend on each task, the “estimate allows for tremendous
variation.”

(Pl. Timing Br. at 14).

It then spins out two

variations, one of which assumes that the task would take 10
employees 86 work-hours each.11

(Pl. Timing Br. at 14).

NRDC

calculates that if each of these employees worked full time on the
project, it could be completed in two weeks.
14).

(Pl. Timing Br. at

It then notes that congressional testimony from agency

personnel “suggests that FDA has already devoted significant time
and resources to searching its files,” and concludes that “it
should take the agency no longer than two weeks to search its own
files for relevant information.”
added)).

(Pl. Timing Br. at 15 (emphases

As the Government points out, this argument is based on

the assumption that “the work required is largely complete,” and
“amount[s] to little more than speculation about the level of
preparation that it takes to initiate a complex set of drug
withdrawal

proceedings.”

(Gov’t

Timing

Reply

at

8).

The

Government contends that, even if the literature has been reviewed
previously for other purposes, that review not only needs to be
updated, but also “tailor[ed] . . . to the specific goal of
initiating . . . withdrawal proceedings for individual products.”
(Gov’t Timing Reply at 8).

If this is not properly accomplished,

11

The plaintiffs dismiss the other variation (which assumes
fourteen employees working on the task full-time for two months) as
“not credible.” (Pl. Timing Br. at 14).
21

the revised NOOHs will be open to challenge on the basis of
“incompleteness [and a] lack of scientific rigor.”

(1st Flynn

Decl., ¶ 9).
NRDC’s support for its abbreviated schedule consists of a
declaration by Dr. Lance Price, an associate professor who directs
the Center for Microbiomics and Human Health and the Center for
Food Microbiology and Environmental Health at the Translational
Genomics

Research

institute.

Institute,

a

nonprofit

biomedical

research

(Declaration of Lance Price, Ph.D. dated May 23, 2012

(“Price Decl.”), ¶ 1).

Professor Price estimates that it would

take one graduate-level research assistant working full-time sixty
days to complete the review or two such research assistants thirty
days.

(Price Decl., ¶ 6).

However, these estimates do not appear

to take into account the purposes of the review.

Moreover, the

fact that such a review could be performed by research assistants
working full-time on the project in an academic environment says
little about the time requirements for civil servants in a federal
agency who have other responsibilities.

Indeed, NRDC’s two-week

estimate appears to rely on the unfounded assumption that agency
personnel will be able to devote their undivided time and attention
to this project.
Similarly,

NRDC’s

insistence

that

any

hearings

can

be

completed within 21 months of issuance of the revised NOOHs (Pl.
Timing Br. at 24) is unsupported and, as the Government points out,
completely speculative.

(Gov’t Timing Reply at 9).

For example,

it does not appear to take into account the potential number of
22

requested hearings that the FDA will have to hold.
The agency is in the best position to analyze the issue and
propose a realistic schedule that is not based on unsupported
assumptions, but rather on its expertise, and it has done so.

See

International Chemical Workers Union, 958 F.2d 1144, 1150 (D.C.
Cir. 1992) (accepting agency’s estimate of time needed to complete
rulemaking); Brock, 823 F.2d at 629 (adopting agency’s proposed
timetable even though target date was “disappointing”); cf. Qwest
Communications International v. Federal Communications Commission,
398

F.3d

1222,

1239

(10th

Cir.

2005)

(declining

to

impose

“arbitrary” deadline where agency did not propose schedule for
compliance).

Therefore,

I

adopt

the

Government’s

proposed

schedule, which requires issuance of revised NOOHs for penicillin
and tetracyclines in 17 months, and provides an additional 41
months for the hearing process.
C.

(1st Flynn Decl., ¶¶ 16, 25).

Motion to Stay

The Government has requested a stay of the March 22 Order
pending the Second Circuit’s decision on its appeal or, in the
alternative, a stay pending the Second Circuit’s resolution of the
Government’s planned application for a stay in that court.
Stay Memo. at 1).

(Gov’t

“A stay is not a matter of right, even if

irreparable injury might otherwise result.

It is instead an

exercise of judicial discretion, and the propriety of its issue is
dependent upon the circumstances of the particular case.”

Nken v.

Holder, 556 U.S. 418, 433 (2009) (internal quotation marks and
citations omitted).

In deciding whether to issue a stay pending
23

appeal, a court considers four factors:
(1) whether the stay applicant has made a strong showing
that he is likely to succeed on the merits; (2) whether
the applicant will be irreparably injured absent a stay;
(3) whether issuance of the stay will substantially
injure the other parties interested in the proceeding;
and (4) where the public interest lies.
Id. at 434 (internal quotation marks omitted).

“The first two

factors . . . are the most critical,” id., and these factors have
typically been evaluated on a sliding scale, so that a strong
showing that the applicant is likely to succeed excuses a weaker
showing of irreparable injury. Nevertheless, the Supreme Court has
recently emphasized that the applicant must demonstrate that both
factors are satisfied, so that even if a party makes a robust
showing that it is likely to succeed on appeal, it still must also
show that “irreparable injury is likely.”

Winter v. Natural

Resources Defense Council, 555 U.S. 7, 22 (2008).12

The party

seeking the stay bears a heavy burden to “establish[] a favorable
balance of these factors.”

Barcia v. Sitkin, No. 79 Civ. 5831,

2004 WL 691390, at *1 (S.D.N.Y. March 31, 2004) (citing 11 Charles
A. Wright & Arthur R. Miller, Federal Practice and Procedure §

12

Winter dealt with the showing required for the issuance of
a preliminary injunction rather than for a stay pending appeal.
However, the test for a stay “is essentially the same” as the test
for a preliminary injunction.
Citizens for Responsibility and
Ethics in Washington v. Office of Administration, 593 F. Supp. 2d
156, 159 n.1 (D.D.C. 2009)(internal quotation marks omitted); see
also In re St. Johnsbury Trucking Co., 185 B.R. 687, 688 (S.D.N.Y.
1995) (“The standard for issuance of a stay pending appeal is
similar to that governing motions for preliminary injunctions.”).
Winter’s clarification of the standard therefore applies to stay
applications. Consequently, cases discussing the factors a court
must weigh in deciding a preliminary injunction motion are helpful
in analyzing this stay application.
24

2904); see Shays v. Federal Election Commission, 340 F. Supp. 2d
39, 41 (D.D.C. 2004) (noting that the “standards required to
justify the extraordinary remedy of a stay pending appeal” are
“stringent”).
1.

Likelihood of Success on the Merits

Although the oft-repeated standard indicates that an applicant
must “ma[ke] a strong showing that he is likely to succeed on the
merits,” Hilton v. Braunskill, 481 U.S. 770, 776 (1987), if “a
serious legal question is involved,” a stay may issue when the
movant “present[s] a substantial case on the merits . . . and
show[s] that the balance of the equities weighs heavily in favor of
granting the stay,” LaRouche v. Kezer, 20 F.3d 68, 72-73 (2d Cir.
1994); see also Sutherland v. Ernst & Young LLP, __ F. Supp. 2d __,
2012 WL 751970, at *1 (S.D.N.Y. March 6, 2012); cf. Citigroup
Global Markets, Inc. v. VCG Special Opportunities Master Fund
Limited, 598 F.3d 30, 38 (2d Cir. 2010) (holding, in preliminary
injunction context, that Winter does not foreclose a “flexible
standard” of “assessing a movant’s likelihood of success on the
merits”).
The Government argues, as it did in its motions for summary
judgment, that (1) “the plain meaning of [21 U.S.C. § 360b(e)(1)]
provides that the Commissioner’s statutory finding comes only after
[a] hearing or after a sponsor opts not to request a hearing”
(Gov’t

Stay

Memo.

at

8);

(2)

to

the

extent

the

statute

is

ambiguous, the FDA’s interpretation that the finding triggering
withdrawal proceedings occurs after notice and the opportunity for
25

a hearing is reasonable and deserves deference (Gov’t Stay Memo. at
9-10);

(3)

deference

the
as

an

withdrawal

of

“archetypal

the

1977

exercise

NOOHs
of

the

is

entitled

[FDA’s]

to

expert

scientific judgment and regulatory discretion” (Gov’t Stay Memo. at
11); (4) the withdrawal mooted this dispute (Gov’t Stay Memo. at 14
n.8); and (5) the failure to commence withdrawal proceedings is an
unreviewable “‘decision[] not to enforce’” under Chaney, 470 U.S.
at 828 (Gov’t Stay Memo. at 12).
Judge Katz’ thorough opinion in this case addressed each of
these contentions and rejected them.

See Schwartz v. Dolan, 159

F.R.D. 380, 384 (N.D.N.Y. 1995) (“Mere repetition of arguments
previously considered and rejected cannot be characterized as a
‘strong showing’ [of likelihood of success on the merits].”); see
also International Equity Investments, Inc. v. Opportunity Equity
Partners,

Ltd.,

No.

05

Civ.

2745,

2006

WL

1116437,

at

*3-4

(S.D.N.Y. April 26, 2006) (holding that applicant had failed to
show a likelihood of success on the merits when it presented only
arguments that the court had already rejected); Shays, 340 F. Supp.
2d at 45-47 (same).
However, neither party denies that this case involves serious
legal questions regarding the FDA’s responsibilities under the APA,
the FDCA, and the pertinent regulations.
perhaps

most

particularly

the

proper

The issues presented,
identification

of

the

“finding” that triggers the commencement of withdrawal proceedings
under 21 U.S.C. § 360b(e)(1)(B) and the consequences that follow,
are difficult.

Moreover, the appeal will likely present only
26

questions of law, which the Second Circuit will review without
deference.

The

regurgitated
frivolous.

from

Government’s
its

summary

arguments,
judgment

although

papers,

are

largely
far

from

Although the Government may not have made a strong

showing of likelihood of success on appeal, it has presented a
“substantial case on the merits.”

LaRouche, 20 F.3d at 72.

Therefore, the success of its stay application depends on whether
it can “show that the balance of the equities weighs heavily in
favor of granting the stay.”
2.

Id. at 72-73.

Irreparable Injury

To support a stay pending appeal, the applicant must show
“injury that ‘is neither remote nor speculative, but actual and
imminent and cannot be remedied by an award of monetary damages.’”
RxUSA Wholesale, Inc. v. Department of Health and Human Services,
467 F. Supp. 2d 285, 301 (E.D.N.Y. 2006) (quoting Rodriguez v.
DeBuono, 175 F.3d 227, 234 (2d Cir. 1999) (per curiam)).

The

potential for irreparable injury should be evaluated taking into
account the possibility that the ruling sought to be stayed is
erroneous.

See National Immigration Project of the National

Lawyers Guild v. U.S. Department of Homeland Security, __ F. Supp.
2d __, 2012 WL 375515, at *11 (S.D.N.Y. Feb. 7, 2012) (“Thus,
failure to stay the disclosure required by the Order would cause
the

Government

irreparable

injury

if

the

ruling

[were]

erroneous.”).
The Government contends that it will suffer irreparable injury
if a stay is not granted because the significant resources the FDA
27

will

be

required

to

expend

in

order

to

commence

withdrawal

proceedings will “compromise FDA’s ability to pursue its goals with
respect to antimicrobial resistance and animal drug licensing by
diverting resources away from those programs.” (Gov’t Stay Memo. at
15-18).

This argument does not demonstrate irreparable harm

sufficient for the imposition of a stay.
First, the Government undermines its own argument when it
asserts that its proposed schedule (which is the schedule I have
adopted) “is intended to appropriately balance resources devoted to
Withdrawal Proceedings . . . with resources required for CVM’s
myriad other responsibilities.”

(Gov’t Timing Reply at 9).

Next,

as a practical matter, the schedule allows up to 17 months for the
initial literature review and an additional period of years for
completion of the withdrawal proceedings.

These generous time

limits further weaken the Government’s claims of irreparable harm
in light of the fact that the appeal will be fully briefed and
ready for argument and decision by the end of this year.13 The only
task on the FDA’s schedule during the pendency of the appeal, then,
is the beginning of the literature review -- an entirely internal
process which, even if “resource-intensive” (Gov’t Stay Memo. at
14), is hardly likely to infringe significantly on the FDA’s
operations. Any putative harm attendant on the finalization of the
13

The Government’s opening brief is due September 4, 2012.
(Order, Natural Resources Defense Council v. United States Food &
Drug Administration, Case No. 12-2106 (2d Cir. June 19, 2012), ECF
No. 25). Pursuant to the Second Circuit’s rules, briefing must be
complete by December 18, 2012, absent extraordinary circumstances.
Local Rules and Internal Operating Procedures of the Court of
Appeals for the Second Circuit, Rule 31.2.
28

revised NOOHs and subsequent events is too speculative to consider,
as it is likely that by the time these tasks must be completed, the
appeal will have been decided.

To the extent that the Government

worries that compulsory withdrawal proceedings will inhibit drug
sponsors from participating in the voluntary withdrawal program,
this concern seems misplaced.

As noted, the literature review

process is internal to the FDA; it does not compel the drug
sponsors to do anything.

There is no reason that the FDA’s

literature review should drive sponsors who were already inclined
to participate in the voluntary program to reverse course.

It is

even possible that more sponsors will participate in order to stave
off compelled action.
Moreover, the argument “that potentially wasted and diverted
staff

resources

“meritless.”

constitutes

irreparable

harm”

has

been

held

Shays, 340 F. Supp. 2d at 48; see also Graphic

Communications Union v. Chicago Tribune Co., 779 F.2d 13, 15 (7th
Cir.

1985)

(holding

that

costs

incurred

as

consequence

of

compliance with court order do not show irreparable harm). This is
a sensible rule.

As NRDC points out, accepting the Government’s

argument would almost always result in a finding of irreparable
harm whenever an agency was required to comply with a court order.
(Plaintiffs’ Opposition to the Government’s Motion for a Stay
Pending Appeal (“Pl. Stay Memo.”) at 16).

As a consequence, stays

pending appeal would become routine, conflicting with the rule that
such relief should be “extraordinary.”

Shays, 340 F. Supp. 2d at

41; cf. Graphic Communications, 779 F.2d at 15 (noting that if
29

costs

imposed

by

compliance

with

court

order

constituted

irreparable harm, every such order “would be deemed to create
irreparable harm, and it would be easy to get such orders stayed”).
The Government attempts to distinguish Shays, asserting that
in that case, “not only did the [agency] not make any claim that
its ability to fulfill its mission would be compromised without a
stay, but it did not even claim that any specific programs would be
harmed

at

all.

Rather

the

[agency]

made

a

general

(and

unsupported) claim of diversion of resources from other agency
priorities.”

(Gov’t Stay Reply at 7).

The Government cites

nothing -- no document or brief -- that supports its position that
the agency did not in fact present such allegations or submit such
evidence.

More importantly, the Shays opinion itself provides no

support for the Government’s characterization of the evidence
there. In any case, the Government’s assertions about the opinion,
even if supported, do not undermine that court’s categorical
rejection of the argument that the diversion of

agency resources

constitutes irreparable harm.
The additional cases the defendants marshal as support fare no
better. The Government cites James River Flood Control Association
v. Watt, 680 F.2d 543 (8th Cir. 1982) (per curiam), and Arkansas
Peace Center v. Arkansas Department of Pollution, 992 F.2d 145 (8th
Cir. 1993) to bolster its position that diversion of agency
resources is irreparable harm sufficient to merit a stay. In James
River,

the

district

court

issued

a

preliminary

injunction

prohibiting the Department of the Interior from acquiring land on
30

which it intended to build a pumping station, “pending the outcome
of proceedings . . . regarding the inadequacy of the Environmental
Impact Statement.” 680 F.2d at 544. In Arkansas Peace Center, the
district court preliminarily enjoined the defendant agencies from
incinerating certain hazardous wastes based on allegations that
“the incineration was proceeding in violation of certain federal
and state regulations regarding incinerator performance.” 992 F.2d
at 146. In both cases, the court found that preventing the actions
would irreparably harm the agencies.
F.2d at 544.

Id. at 147; James River, 680

However, in neither case did the Eighth Circuit

suggest that the enjoined activities were statutorily mandated, as
Judge Katz found here.
redistribution

of

Nor did the appellate court suggest that

agency

preliminary injunctions.

resources

motivated

staying

the

These cases are therefore of doubtful

relevance.
Finally,

the

Government’s

argument

is,

at

its

base,

an

economic one: that the opportunity cost of compliance with the
March 22 Order will irreparably harm the FDA.

But the Government

has not demonstrated that compliance would seriously threaten its
mission or operations.

Rather, it asserts that the diversion of

resources will “compromise” the FDA’s pursuit of goals relating to
antimicrobial resistance.

(Gov’t Stay Memo. at 15; Gov’t Stay

Reply at 6; 2d Flynn Decl., ¶ 4).

As support, it cites concerns

such as a “drain [of] resources” from certain other FDA programs
(1st Flynn Decl., ¶ 26), the possibility of delay in certain
programs (1st Flynn Decl., ¶ 27), and difficulty fully staffing
31

both the voluntary withdrawal project and the formal withdrawal
proceedings at all times (2d Flynn Decl., ¶ 8). This evidence does
not show that compliance with the March 22 Order will substantially
endanger the CVM’s or the FDA’s mission to “protect the public
health by ensuring that . . . human and veterinary drugs are safe
and effective.”

21 U.S.C. § 393(b)(2)(B).

In short, the Government has not shown that it will be
irreparably harmed if a stay pending appeal is not granted.
3.
The

Injury to the Plaintiffs and the Public Interest

Government

recognizes,

and

NRDC

does

not

appear

to

dispute, that the plaintiffs “are in the same position as members
of the public.”

(Gov’t Stay Memo. at 19).

In this case, then, the

last two factors are best discussed together. (Gov’t Stay Memo. at
18-20; Pl. Stay Memo. at 20-22).
The Government asserts that the public interest supports a
stay because the FDA “has determined that the public health
concerns regarding production uses of antibiotics in animal feed
would be most quickly addressed by finalizing and implementing” the
voluntary program it prefers.

(Gov’t Stay Memo. at 18-19).

Additionally, it asserts that the FDA’s “preferred regulatory
strategy covers a much broader set of drugs than the contemplated
by the March 22 Order.”

(Gov’t Stay Memo. at 19).

The Government fails to take into account the fact that the
March 22 Order held that the FDCA requires the FDA to initiate
withdrawal proceedings.

“When administrative agencies fail to

follow statutory procedures, the public suffers.”
32

Apotex, Inc. v.

U.S. Food & Drug Administration, 508 F. Supp. 2d 78, 88 (D.D.C.
2007).
In addition, for all its insistence that the voluntary program
will succeed, the Government has presented “no hard evidence that
the drug sponsors have agreed or will agree[] to the proposed
measures.”

(June 1 Order at 49-50).

The single piece of evidence

it submitted (which has been struck from the record) expressed
tepid support, at best, from the affected community.

At oral

argument, the Government was not able to articulate any more
convincing reason for its confidence.

(Tr. at 46-49).

As the

plaintiffs note, the voluntary program is passive insofar as it
requires drug sponsors to approach the FDA if they are interested
in taking part in the program.

(Pl. Stay Br. at 21; Final Response

to Citizen Petition dated Nov. 7, 2011, attached at Exh. A to
Declaration of Mitchell S. Bernard dated Feb. 21, 2012, at 4).
Although

the

Government

may

hold fast to its “hope and belief

. . . that everyone will move together at the same time” (Tr. at
20), insufficient buy-in by the drug sponsors will likely result,
ultimately, in the same formal withdrawal procedures required under
the both the March 22 Order and now this order.

(Gov’t Stay Brief

at 16-17; 2d Flynn Decl., ¶ 5).
On

the

other

hand,

engaging

in

the

mandated

withdrawal

procedures promptly will allow drug sponsors the opportunity to
show that the challenged drug uses are safe.

If they are shown to

be safe, the public interest is likely served by allowing their
continued use.

If, however, they are not shown to be safe, the FDA
33

will be required to withdraw approval, thus safeguarding the
public’s (and the plaintiffs’) health and welfare.

Moreover, as

Judge Katz observed, “nothing prevents the [FDA] from seeking
voluntary cooperation from the drug industry[] in tandem” with
withdrawal proceedings.

(June 1 Order at 49).

Even if both

projects might not be “adequately staffed at all times” (2d Flynn
Decl., ¶ 8), simultaneous engagement will have less deleterious
effects during the relatively short pendency of the appeal.
Finally, the argument that the voluntary program is a better
solution because it addresses drugs in addition to penicillin and
tetracyclines is a straw man.

As the Government concedes, the FDA

is not prohibited in this process from issuing amended NOOHs
addressing the extended range of drugs covered by the voluntary
program.

(Tr. at 31).

It is clear, then, that the plaintiffs are at risk of harm if
a stay is imposed and that the public interest favors enforcement
of the March 22 Order.
further

delay

of

Indeed, given the substantial harm that

withdrawal

proceedings

could

visit

on

the

plaintiffs and the public, the balance of the equities would not
“weigh heavily in favor” of a stay even if the Government had shown
irreparable harm.

LaRouche, 20 F.3d at 72-73.

The Government’s

request for a stay pending decision on the appeal of the March 22
Order is therefore denied.
d.

Interim Stay

As noted, the defendants ask in the alternative that I grant
an interim stay pending resolution of the Government’s anticipated
34

stay application in the Second Circuit.
20).

(Gov't Stay Brief at I,

In support of this interim stay, the Government reI

on its

arguments for the stay pending appeal, which are no more successful
here.

Indeed, as the defendants do not contend that a different

standard appl

s to the interim stay, the arguments fail for the

same reasons.

Actually, the arguments are weaker in the context of

an interim stay, because, given the time schedule adopted here, it
is even less likely that the Government will suffer recognizable
harm in the short time between issuance of this order and the
Second Circuit's decision on the planned application for a stay.
Therefore, the Government's request for an interim stay is denied.
Conclusion
For the foregoing reasons, the plaintiffs' motion to strike
(Docket no.

79)

is granted

stricken from the

in part,

record.

and Document

no.

78 6 is

Government's motion for a

stay

pending appeal, or, in the alternative, for an interim stay pending
resolution of the Government's planned application for a stay in
the Second Circuit (Docket no. 92), is denied.

Furthermore, the

Government is ordered to comply with the Court's order of March 22,
2012, according to the schedule included in paragraphs 11 through
25 of the Declaration of William T.

Flynn dated May 15,

(Docket no. 86).
SO ORDERED.

c)

~"eA C,~~ ~
AMES C. FRANCIS IV
ITED STATES MAGISTRATE JUDGE
35

2012

Dated:

New York, New York
August 8, 2012

Copies mailed this date:
Mitchell S. Bernard, Esq.
Natural Resources Defense Council, Inc.
40 West 20th Street
New York, NY 10011
Avinash Kar, Esq.
fer Ann Sorenson, Esq.
Natural Resources Defense Council, Inc
111 Sutter Street, 20th Floor
San Francisco, CA 94104
A. Barcelo, Esq.
M. London, Esq.
Assistant United States Attorneys
86 Chambers Street
3
Floor
New
, NY 10007

36