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

Filing 93

MEMORANDUM OF LAW in Support re: 92 MOTION to Stay re: 70 Memorandum & Opinion,, pending appeal. MOTION to Stay re: 70 Memorandum & Opinion,, pending appeal.. Document filed by Center for Veterinary Medicine, Bernadette Dunham, Margaret Hamburg, Kathleen Sebelius, United States Department of Health and Human Services, United States Food and Drug Administration. (Barcelo, Amy)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
NATURAL RESOURCES DEFENSE
COUNCIL, INC.; CENTER FOR SCIENCE
IN THE PUBLIC INTEREST; FOOD
ANIMAL CONCERNS TRUST; PUBLIC
CITIZEN, INC.; and UNION OF
CONCERNED SCIENTISTS, INC.,
Plaintiffs,

11 Civ. 3562 (THK)
ECF Case

v.
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
SEBELIUS, in her official capacity as
Secretary, United States Department of
Health and Human Services,
Defendants.
MEMORANDUM OF LAW IN SUPPORT OF
THE GOVERNMENT’S MOTION FOR A STAY PENDING APPEAL

PREET BHARARA
United States Attorney for the
Southern District of New York
Attorney for Defendant
86 Chambers Street, 3rd Floor
New York, New York 10007
Tel.: [phone]
AMY A. BARCELO
Assistant United States Attorney
– Of Counsel –

TABLE OF CONTENTS

PRELIMINARY STATEMENT .....................................................................................................1
BACKGROUND .............................................................................................................................2
A.

Factual Background .................................................................................................2

B.

Plaintiffs’ Claims .....................................................................................................4

C.

The Court’s March 22 Order....................................................................................5

ARGUMENT ...................................................................................................................................6
THE COURT SHOULD GRANT A STAY OF THE ORDER PENDING APPEAL ....................6
A.

Governing Standards................................................................................................6

B.

The Government Will Present a Substantial Case on the Merits on Appeal ...........7

C.

The Government Will Be Irreparably Injured Absent a Stay ................................14

D.

Issuance of a Stay Will Not Substantially Injure Plaintiffs and Is in the
Public Interest .........................................................................................................18

CONCLUSION ..............................................................................................................................20

TABLE OF AUTHORITIES
CASES
American Public Health Ass’n v. Veneman,
349 F. Supp. 1311 (D.D.C. 1972) ................................................................................12
Ark. Peace Ctr. v. Ark. Dep’t of Pollution Control,
992 F.2d 145 (8th Cir. 1993) .......................................................................................15
Auer v. Robbins,
519 U.S. 452 (1997) .....................................................................................................10
Baltimore Gas & Electric Co. v. Natural Res. Def. Council, Inc.,
462 U.S. 87, 103 (1983) ..............................................................................................12
Cobell v. Norton,
428 F.3d 1070 (D.C. Cir. 2005) ...................................................................................13
Ctr. for Int’l Envtl. Law v. Office of U.S. Trade Representative,
240 F. Supp. 2d 21 (D.D.C. 2003) .................................................................................7
Federal Power Comm’n v. Florida Power & Light Co.,
404 U.S. 453, 463 (1972) ............................................................................................12
Gen. Dynamics Lands Sys., Inc. v. Cline,
540 U.S. 581 (2004) .................................................................................................8, 10
Heckler v. Chaney,
470 U.S. 821 (1985) ...............................................................................................12, 13
Helvering v. Stockholds Enskilda Bank,
293 U.S. 84 (1934) .......................................................................................................10
Henley v. FDA,
77 F.3d 616 (2d Cir. 1996)...........................................................................................12
James River Flood Control Ass’n v. Watt,
680 F.2d 543 (8th Cir. 1982) .................................................................................15, 19
Jerome Stevens Pharm., Inc. v. FDA,
402 F.3d 1249 (D.C. Cir. 2005) ...................................................................................12
LaRouche v. Kezer,
20 F.3d 68 (2d Cir. 1994) ..............................................................................................7
ii

McBryde v. Comm. to Review Circuit Council Conduct and Disability Orders of the
Judicial Conference of the United States,
264 F.3d 52 (D.C. Cir. 2001) .......................................................................................14
Mich. Coal. of Radioactive Users, Inc. v. Griepentrog,
945 F.2d 150 (6th Cir. 1991) .........................................................................................7
Mohammed v. Reno,
309 F.3d 95 (2d Cir. 2002).............................................................................................6
Natural Res. Def. Council, Inc. v. Nuclear Regulatory Comm’n,
680 F.2d 810 (D.C. Cir. 1982) .....................................................................................14
Natural Res. Def. Council, Inc. v. SEC,
606 F.2d 1031, 105 (D.C. Cir. 1979) ..........................................................................13
Nken v. Holder,
556 U.S. 418 (2009) .......................................................................................................6
Norton v. S. Utah Wilderness Alliance,
542 U.S. 55 (2004) .........................................................................................................9
Ruiz v. Estelle,
650 F.2d 555 (5th Cir. 1981) .......................................................................................19
Schering Corp. v. FDA,
51 F.3d 390 (3d Cir. 1995)...........................................................................................11
Schering Corp. v. Heckler,
779 F.2d 683 (D.C. Cir. 1985) .....................................................................................12
Sierra Club v. Whitman,
268 F.3d 898 (9th Cir. 2001) .......................................................................................13
Wash. Metro. Area Transit Comm’n v. Holiday Tours, Inc.,
559 F.2d 841 (D.C. Cir. 1977) ...................................................................................6, 7
In re World Trade Ctr. Disaster Site Litig.,
503 F.3d 167 (2d Cir. 2007)...........................................................................................6
STATUTES AND REGULATIONS
21 U.S.C. § 393(b)(1) ......................................................................................................................9
21 U.S.C. § 360b(e)(1)…………………………………………………………………….passim
iii

5 U.S.C. § 706(1) .............................................................................................................................4
21 C.F.R. § 5.84 (1977) ...................................................................................................................9
21 C.F.R. § 514.115(b)(3)(ii) .................................................................................................5, 9, 10
21 C.F.R. § 514.200(c).....................................................................................................................9

OTHER AUTHORITIES
42 Fed. Reg. 43772 (Aug. 30, 1977)................................................................................................2
42 Fed. Reg. 56264 (Oct. 21, 1977) .................................................................................................2
43 Fed. Reg. 53827 (Nov. 17, 1978)................................................................................................3
76 Fed. Reg. 79697 (Dec. 22, 2011) ………………………………………………………….4, 11

iv

The above-captioned defendants (the “Government”), by their attorney, Preet Bharara,
United States Attorney for the Southern District of New York, respectfully submit this
memorandum of law in support of their motion to stay this Court’s order of March 22, 2012 (the
“March 22 Order”) (Dkt. No. 70), pending the Government’s appeal of that Order to the United
States Court of Appeals for the Second Circuit. If the Court denies the Government’s motion for
a stay pending appeal, the Government respectfully requests an interim stay of the March 22
Order pending disposition of the Government’s motion for a stay in the United States Court of
Appeals for the Second Circuit.
PRELIMINARY STATEMENT
This Court should stay the March 22 Order pending appeal. In that order, the Court held
that a preliminary proposal, announced almost 35 years ago, to withdraw approvals for certain
non-therapeutic uses of the penicillin and tetracycline classes of drugs in animal feed constituted
a “finding” under Section 512(e)(1) (21 U.S.C. § 360b(e)(1)) of the Federal Food, Drug, and
Cosmetic Act (“FDCA”), and requires the United States Food and Drug Administration (“FDA”
or the “Agency”) to initiate adversarial proceedings to withdraw approvals for those classes of
drugs. That holding is unprecedented and contrary to FDA’s understanding of its authority under
the FDCA, the statute it is tasked with administering. Accordingly, the Government presents a
substantial case for appeal.
The March 22 Order also compels sweeping, resource-intensive agency action. FDA is
currently implementing a regulatory strategy to end the use of medically important antimicrobial
drugs to promote growth in animals. FDA believes that its current approach will help achieve its
public health goals more quickly and efficiently than the strategy the Agency proposed decades
ago (and this Court has ordered FDA to readopt). Initiating withdrawal proceedings now would

require FDA to expend substantial resources towards a regulatory strategy that the Agency has
abandoned for now, and would draw resources away from FDA’s current and broader strategy to
address antimicrobial resistance and other work.
A stay pending appeal is necessary because the beginning phases of those withdrawal
proceedings would be resource-intensive. FDA would need to expend a substantial amount of
resources during the course of its appeal, which it could not recapture even if the Second Circuit
reverses or vacates the March 22 Order.
Neither Plaintiffs nor the public interest would suffer substantial harm if a stay is granted.
If initiation of the withdrawal proceedings is stayed, FDA would continue to work toward
implementing its regulatory strategy to mitigate the problem of antimicrobial resistance.
BACKGROUND
A. Factual Background
The Government assumes the Court’s familiarity with the legal framework and factual
background of the claim at issue here, which is explained in detail in the Government’s Opening
Brief in Support of its Motion for Summary Judgment, dated January 9, 2012 (“Govt’s S.J. Br.”)
at 2-10 (Dkt. No. 41). As a brief summary of the facts most relevant here: in 1977, the Bureau of
Veterinary Medicine (“BVM”), a subsidiary bureau of FDA,1 published two Notices of
Opportunity for Hearings proposing to withdraw the approval of penicillins and tetracyclines in
animal feeds for certain “nontherapeutic” uses (the “1977 NOOHs”) because of concerns that it
had about antimicrobial resistance.2 42 Fed. Reg. 43772, 43773 (Aug. 30, 1977), attached as

1

In 1984, BVM became known as the Center for Veterinary Medicine (“CVM”), as it is
known today.
2

Antimicrobial resistance is a decreased susceptibility of bacteria to an antimicrobial drug,
which is a drug that works against a variety of microorganisms, such as bacteria, viruses, fungi,
2

Exhibit D to the Declaration of Amy A. Barcelo dated January 9, 2012 (“Jan. Barcelo Decl.”); 42
Fed. Reg. 56264, 56266 (Oct. 21, 1977), Jan. Barcelo Decl. Ex. E. In response to the 1977
NOOHs, numerous manufacturers (also known as “sponsors”) of products subject to the notices
(the “NOOH Products”) requested hearings pursuant to the FDCA, 21 U.S.C. § 360b(e)(1), to
contest the proposed withdrawals. 43 Fed. Reg. 53827, 53828 (Nov. 17, 1978), attached as Ex.
G to the Jan. Barcelo Decl. FDA granted the requests for hearings, but soon after, the
Congressional committee responsible for FDA’s appropriations requested that the Agency
abstain from holding hearings and instead study the issue of antimicrobial resistance in more
depth. March 22 Order at 13.
FDA decided to study the issues of antimicrobial resistance, and the Agency eventually
concluded not to pursue the withdrawal proceedings initiated in 1977 for penicillins and
tetracyclines for the nontherapeutic uses (i.e., “growth promotion” uses) for antimicrobial drugs
that are considered important to human medicine (“Medically Important Antimicrobials”). See
Supplemental Declaration of William T. Flynn dated June 1, 2012 (“Second Flynn Decl.”) Ex.
A at 13-17; Second Flynn Decl. Ex. B at 18-22; Jan. Barcelo Decl. Ex. I at 3-4, Jan. Barcelo
Decl. Ex. J at 2-4. FDA therefore formulated an alternative regulatory strategy that would focus
first on working with drug sponsors to voluntarily eliminate the injudicious use of such drugs,
with the potential for more compulsory regulatory action later, if needed. Jan. Barcelo Ex. I at 4;
Jan. Barcelo Decl. Ex. J at 4; see also Second Flynn Decl. Ex. C at 7.
FDA publicly announced its new plan in 2010 when it published a draft guidance titled
The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,
draft Guidance for Industry #209 (“Draft GFI 209”). Second Flynn Decl. Ex. A. Draft GFI 209

and parasites. Antimicrobial resistance occurs after bacteria are exposed to an antimicrobial drug
and continue to survive in the drug’s presence. See Jan. Barcelo Decl. C at 1.
3

announced FDA’s plan to work with sponsors to voluntarily withdraw approvals for growthpromotion uses, and also to make labeling changes sufficient to require that Medically Important
Antimicrobials be used for therapeutic purposes only under the direction of a veterinarian. See
id. at 17. On April 11, 2012, FDA took another important step to implement its strategy by
publishing a final version of Draft GFI 209 (which, accordingly, is now known as GFI 209), and
published Draft Guidance for Industry 213 (“Draft GFI 213”), which proposes detailed
instructions to guide sponsors on how to withdraw their existing approvals for growth-promotion
indications (i.e., using antimicrobial drugs to promote the growth of food producing animals) and
transition the remaining therapeutic indications (e.g., using antimicrobial drugs to prevent or
treat sickness or disease) to veterinarian oversight. Second Flynn Decl. Exs. B & C.
On December 16, 2011, FDA withdrew the 1977 NOOHs, and explained that it was
doing so because of: (1) its decision to pursue other regulatory strategies to achieve the Agency’s
goals with respect to antimicrobial resistance, (2) the outdated nature of the 1977 NOOHs, and
(3) the fact that if, in the future, FDA decides to seek to involuntarily withdraw approval of any
antimicrobial drugs for use in animals, FDA would need to prioritize which drugs to focus on
first. 76 Fed. Reg. 79697 (Dec. 22, 2011), Ex. L Jan. Barcelo Decl.
B. Plaintiffs’ Claims
Plaintiffs began this action by filing a complaint on May 25, 2011, which they amended
on July 7, 2011. (Dkt. No. 11.) Plaintiffs brought claims in the amended complaint pursuant to
the Administrative Procedures Act and, specifically, 5 U.S.C. § 706(1), seeking to “compel
agency action unlawfully withheld or unreasonably delayed.” In the claim that is at issue in the
instant motion, Plaintiffs alleged that the Government had “unlawfully withheld” further action
with respect to the 1977 NOOHs. Specifically, in briefing on the parties’ cross-motions for

4

summary judgment, Plaintiffs originally argued that, because it had issued the 1977 NOOHs,
FDA was required to now “withdraw approval” for subtherapeutic uses of the NOOH Products.
See, e.g., Plaintiffs’ Brief in Support of their Motion for Summary Judgment at 8-9 (Dkt. No.
20). Plaintiffs later conceded that they were not entitled to such relief and instead sought a Court
order requiring FDA to update the 1977 NOOHs, publish such updated notices, and then hold
hearings on the withdrawals it had proposed in 1977. See, e.g., Plaintiffs’ Opposition and Reply
Brief in Support of their Motion for Summary Judgment at 3, 20.
C. The Court’s March 22 Order
On March 22, 2012, the Court granted Plaintiffs’ motion for summary judgment and
denied the Government’s cross-motion for summary judgment. In granting Plaintiffs’ motion,
the Court ordered FDA to “initiate withdrawal proceedings” as contemplated by 21 U.S.C.
§ 360b(e)(1) for the “subtherapeutic” uses of the penicillin and tetracycline classes of drugs (the
“Withdrawal Proceedings”). March 22 Order at 54. Specifically, the court ordered FDA to
undertake the following actions: “the Commissioner of the FDA or the Director of the CVM
must 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 evidentiary hearing.
If, at the hearing, the drug sponsors fail to show that the use of the drugs is safe, the
Commissioner must issue a withdrawal order.” Id.
In reaching that holding, the Court relied on its interpretation of 21 U.S.C. § 360b(e)(1);
an FDA regulation promulgated in connection with that statutory provision, 21 C.F.R.
§ 514.115(b)(3)(ii); and other FDA regulations setting forth hearing procedures, to hold: (1) that
FDA subsidiary bureau BVM had the authority to make statutory safety “findings” within the

5

meaning of 21 U.S.C. § 360b(e)(1), (2) that the 1977 NOOHs reflected such statutory FDA
“findings,” and (3) that, as a consequence of having made such “findings” in 1977, the Agency
was obligated to commence adversarial proceedings to withdraw the applicable drug approvals,
even though FDA withdrew the 1977 NOOHs in December 2011. March 22 Order at 49-53.
On May 21, 2012, the Government filed a notice of appeal from the March 22 Order.
(Dkt. No. 88).
ARGUMENT
THE COURT SHOULD GRANT A STAY OF THE ORDER PENDING APPEAL
A. Governing Standards
The Court considers four factors when determining whether to grant a stay pending
appeal: “(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.” Nken v. Holder, 556 U.S. 418, 434 (2009) (citation and internal
quotation marks omitted); In re World Trade Ctr. Disaster Site Litig., 503 F.3d 167, 170 (2d Cir.
2007) (citations and internal quotation marks omitted). These factors are not prerequisites to be
met, but rather are considerations to be balanced. “[T]he degree to which a factor must be
present varies with the strength of the other factors, meaning that more of one [factor] excuses
less of the other.” World Trade Ctr., 503 F.3d at 170 (alteration in original; citation and internal
quotation marks omitted).
“‘The necessary ‘level’ or ‘degree’ of possibility of success will vary according to the
court’s assessment of the other [stay] factors.’” Mohammed v. Reno, 309 F.3d 95, 101 (2d Cir.
2002) (quoting Wash. Metro. Area Transit Comm’n v. Holiday Tours, Inc., 559 F.2d 841, 843

6

(D.C. Cir. 1977) (second alteration in original)). “The probability of success that must be
demonstrated is inversely proportional to the amount of irreparable injury plaintiff[ ] will suffer
absent the stay.” Id. (quoting Mich. Coal. of Radioactive Users, Inc. v. Griepentrog, 945 F.2d
150, 153 (6th Cir. 1991) (alteration in original)). Where the other factors are satisfied, the
Government need only demonstrate “a substantial case on the merits,” rather than a strong
likelihood of success, in order to obtain a stay. See LaRouche v. Kezer, 20 F.3d 68, 72-73 (2d
Cir. 1994) (“movant need only present a substantial case on the merits when a serious legal
question is involved and show that the balance of the equities weighs heavily in favor of granting
the stay”); Ctr. for Int’l Envtl. Law v. Office of U.S. Trade Representative, 240 F. Supp. 2d 21,
22 (D.D.C. 2003) (same).
B. The Government Will Present a Substantial Case on the Merits on Appeal
On appeal, the Government will present substantial arguments that the Second Circuit
should reverse or vacate the March 22 Order. As far as the Government is aware, the Court’s
ruling—that the mere proposal to withdraw a drug and the publication of an NOOH constitutes a
statutory “finding” that triggers a nondiscretionary duty requiring FDA to pursue the withdrawal
further—is unprecedented. Given the novelty of this holding, the statutory language, and the
relevant case law, the Government’s appeal will present a “substantial case” that the Court erred
in its interpretation of FDA’s obligations under 21 U.S.C. § 360b(e)(1) and FDA’s related
regulations, and erroneously held that BVM’s issuance of the 1977 NOOHs reflected final
statutory “findings” by the Commissioner pursuant to 21 U.S.C. § 360b(e)(1) that the NOOH
Products were not “shown to be safe” and must be withdrawn. The Government will also
present substantial arguments that the Court erred when it ruled that the 1977 NOOHs can

7

provide a basis to require FDA to move forward with the Withdrawal Proceedings, because FDA
exercised its discretion to withdraw those notices in December 2011.
This Court erred in holding that the 1977 NOOHs, which BVM issued before drug
sponsors were provided an “opportunity for [a] hearing,” constituted FDA’s statutory “finding”
in favor of withdrawal pursuant to 21 U.S.C. § 360b(e)(1).3 March 22 Order at 29-47. On the
contrary, the plain meaning of the statute provides that the Commissioner’s statutory finding
comes only after the hearing or after a sponsor opts not to request a hearing. The Court’s
contrary holding contradicts the plain language of section 360b(e)(1). Specifically, in placing
the phrase “after due notice and opportunity for hearing” near the beginning of the sentence in
section 360b(e)(1), Congress conveyed its intention that any of the events described following
that phrase (including the Commissioner’s final findings) would occur only “after” sponsors are
granted “due notice and opportunity for hearing.” 4

3

Under 21 U.S.C. § 360b(e)(1), “[t]he Secretary shall, after due notice and opportunity for
hearing to the applicant, issue an order withdrawing approval of an application filed pursuant to
subsection (b) of this section with respect to any new animal drug if the Secretary finds” that any
of the conditions or events enumerated in 21 U.S.C. § 360b(e)(1)(A) through (F) are shown to
have occurred. The March 22 Order found that 21 U.S.C. § 360b(e)(1)(B) was the subsection
most relevant here. March 22 Order at 23 n.9. That subsection provides for withdrawal if “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).
4

The Government also has strong arguments that factors on which the Court relied in
concluding that the “finding” referred to in section 360b(e)(1) instead occurs before the hearing
do not provide support the Court’s conclusion. For example, different language in other
statutory provisions regarding when the Agency will make “findings” and hold hearings, see
March 22 Order at 31-33 (looking to 21 U.S.C. § 360b(d) and language in another part of 21
U.S.C. § 360b(e)(1)) must be interpreted in light of the basic principle of statutory construction
that “statutory language must be read in context since a phrase gathers meaning from the words
around it.” Gen. Dynamics Lands Sys., Inc. v. Cline, 540 U.S. 581, 598 (2004). Indeed, the fact
that the exigency clause of section 360b(e)(1) on which the Court relies clearly contemplates a
8

To the extent that section 360b(e)(1) contains any ambiguity regarding whether the
“finding” described by that provision is to occur before or after the hearing, FDA’s interpretation
of that provision is entitled to Chevron deference. March 22 Order at 35; see also Govt’s S.J. Br.
at 16-18. The Court’s failure to accord such deference to FDA’s interpretation of section
360b(e)(1) was based solely on its flawed conclusion that the “finding” described in section
360b(e)(1) is the same “finding” described in FDA regulation, 21 C.F.R. § 514.115(b)(3)(ii).
See March 22 Order at 35-39. Because the regulation describes a “finding” that occurs before a
hearing on the proposed withdrawal is held, the Court concluded that so must the statutory
“finding.” Id.
That ruling, however, failed to accord proper deference to FDA’s reasonable
interpretation of the statutes and its own regulations. Indeed, FDA’s longstanding view is that a
proposal to withdraw a drug does not equate to the final decision to withdraw the drug. 5 The

pre-hearing “finding” supports the conclusion that different language used in the portion of
section 360b(e)(1) at issue here reflects Congressional intent that the “findings” at issue here
occur only after the contemplated hearing.
The Court also relied on an FDCA provision referring to FDA’s general “mission.”
March 22 Order at 33 (citing 21 U.S.C. § 393(b)(1)-(2)). But as the Supreme Court has held,
“broad statutory mandate” cannot provide a basis to compel specific agency action. See Norton
v. S. Utah Wilderness Alliance, 542 U.S. 55, 66-67 (2004).
5

That view is reflected in various FDA regulations. Specifically, as FDA regulations
reflect, in withdrawal proceedings, CVM and the drug sponsors are adversaries advocating,
respectively, in favor of, and against withdrawal, with the Commissioner or an Administrative
Law Judge serving as the fact-finder. 21 C.F.R. § 514.200(c) (hearings are required if “genuine
and substantial issue of fact precludes . . . withdrawal of approval of the application). This
procedure reflects that the issuance by BVM of an NOOH is no more than the first step in a
process ultimately aimed at resolving factual issues and possibly making a final finding.
Likewise, although the Commissioner had delegated to BVM the authority to “issue
notices of an opportunity for a hearing on proposals to refuse approval or to withdraw approval
of new animal drug applications,” 21 C.F.R. § 5.84 (1977), Ex. M to Jan. Barcelo Decl.; see also
FDA Staff Manual Guidelines § 1410.10(1)(A)(1) (delegation to CVM today), Ex. A to Jan.
Barcelo Decl., BVM did not have authority to issue an actual “notice of withdrawal of approval”
unless “the opportunity for hearing ha[d] been waived,” Jan. Barcelo Decl. Exs. A &M. This
authority to withdraw approvals was reserved to the Commissioner, which also reflects FDA’s
9

designation of “findings” at the beginning and end of the drug withdrawal process does not mean
that both findings are the same or carry the same significance. The word “finding” used in two
different contexts may carry two different meanings, because the word may refer to two different
things that are being “found.” See, e.g., Gen. Dynamics Lands Sys., 540 U.S. at 582 (“[S]tatutory
language must be read in context since a phrase gathers meaning from the words around it.”);
Helvering v. Stockholds Enskilda Bank, 293 U.S. 84, 87 (1934) (“[M]ost words admit of
different shades of meaning, susceptible of being expanded or abridged to conform to the sense
in which they are used.”). Here, the regulation contemplates only a preliminary “finding” that
triggers the withdrawal process, and the statute refers to a final “finding” that actually forms a
basis to withdraw approval. It is reasonable for FDA to have used this common word differently
in the regulation, and FDA’s interpretation of its own regulation should receive judicial
deference. See Auer v. Robbins, 519 U.S. 452, 461-63 (1997) (an “agency’s interpretations [of
its own regulations] are . . . entitled to deference and are ‘controlling unless plainly erroneous or
inconsistent with the regulation’”).
Indeed, the Court recognized that under its interpretation of 21 U.S.C. § 360b(e)(1), two
“findings” are necessary—one before, and one after, the hearing, March 22 Order at 31 n.11—
but the Court did not reconcile its view with the statute’s reference to only one “finding.” It is
only logical that, to the extent that there are two required findings, the first would function to
commence the withdrawal process (the finding referred to in 21 C.F.R. § 514.115(b)(3)(ii)) and
the second would constitute a final order that concludes the process (the finding referred to in 21
U.S.C. § 360b(e)(1)). Accordingly, to the extent that section 360b(e)(1) contains any ambiguity,
that ambiguity should be resolved in favor of FDA’s interpretation, pursuant to which the
intention that to the extent the issuance of an NOOH reflects an agency “finding,” that “finding”
is merely preliminary, and is not the “finding” described in 21 U.S.C. § 360b(e)(1).
10

“finding” described in section 360b(e)(1) has never occurred and FDA is under no mandatory
duty to convene Withdrawal Proceedings now, 35 years after the 1977 NOOHs issued.
FDA will also make a strong showing on appeal that regardless of the effect of the 1977
NOOHs while they were in place, because FDA withdrew those NOOHs in December 2011, see
76 Fed. Reg. at 79700, Jan. Barcelo Decl. Ex. L, those withdrawn notices cannot provide a basis
to now compel FDA to move forward with the Withdrawal Proceedings.
The Court erred in its ruling that FDA had not effectively withdrawn the 1977 NOOHs
(contrary to FDA’s December 2011 announcement in the Federal Register that it had) because
the Agency’s stated reasons for withdrawing those NOOHs did not, in the Court’s view, include
withdrawal of the scientific “findings” that formed the basis for the 1977 NOOHs. March 22
Order at 49-52. That ruling overlooked FDA’s explanation in its December 2011 withdrawal of
the 1977 NOOHs that the scientific bases for the NOOHs had were outdated, and any
Withdrawal Proceeding would need to be based on contemporary science. 76 Fed. Reg. 79697,
79700 (Dec. 22, 2011), Jan. Barcelo Decl. Ex. L at 4. Indeed, if FDA were to move forward
with the Withdrawal Proceedings, it would first need to “determine the Agency’s current
scientific positions with regard to the microbial food safety of the NOOH Products.” Declaration
of William T. Flynn dated May 15, 2012 (“First Flynn Decl.”) at ¶ 13 (Dkt. No. 86). But in
exercising its regulatory discretion, FDA opted not to update the NOOHs and proceed with
Withdrawal Proceedings immediately, but instead decided to implement a phased enforcement
program that focuses first on voluntary compliance. This is an archetypal exercise of the
agency’s expert scientific judgment and regulatory discretion, to which the courts should defer.
See Schering Corp. v. FDA, 51 F.3d 390, 399 (3d Cir. 1995) (FDA’s “judgments as to what is
required to ascertain the safety and efficacy of drugs fall squarely within the ambit of the FDA’s

11

expertise and merit deference from us”); see also Henley v. FDA, 77 F.3d 616, 620 (2d Cir.
1996) (“[T]he FDA’s determination of what labeling best reflects current scientific information
regarding the risks and benefits of [the drug] involves a high degree of expert scientific
analysis.”); Baltimore Gas & Electric Co. v. Natural Res. Def. Council, Inc., 462 U.S. 87, 103
(1983); Federal Power Comm’n v. Florida Power & Light Co., 404 U.S. 453, 463 (1972).
Established principles of agency discretion also underscore why, on appeal, the
Government will present a substantial case that FDA’s decision not to proceed immediately with
adversarial Withdrawal Proceedings should be unreviewable as a “decision[] not to enforce”
under Heckler v. Chaney, 470 U.S. 821, 828 (1985), and its progeny, and therefore not subject to
judicial review. It is well settled that FDA has broad discretion regarding how to enforce
applicable requirements in the FDCA. See, e.g., Chaney, 470 U.S. at 838 (FDA’s decision to not
“take various investigatory and enforcement actions” pursuant to the FDCA was exempt from
judicial review); Jerome Stevens Pharm., Inc. v. FDA, 402 F.3d 1249, 1258 (D.C. Cir. 2005)
(FDA’s decision to allow manufacturers of unapproved drugs two extra years to submit new drug
applications was an “exercise of FDA’s enforcement discretion” and immune to judicial review);
Schering Corp. v. Heckler, 779 F.2d 683, 686 (D.C. Cir. 1985) (FDA’s decision to abstain from
action while it considered whether a product was a “new drug” is an exercise of the Agency’s
unreviewable discretion because “there are no statutory guidelines compelling the agency to
investigate or pursue enforcement actions within any specified time frame”), id. at 687 (decision
to abandon ongoing enforcement proceedings also within FDA’s discretion).6

6

American Public Health Ass’n v. Veneman, 349 F. Supp. 1311, 1315 (D.D.C. 1972), on
which the Court relied in holding the contrary, slip op. at 52, was decided thirteen years before
Chaney, and dealt with a challenge to a different regulatory undertaking by FDA to which
specific timeframes applied. 349 F. Supp. at 1313-15.
12

Indeed, FDA’s December 2011 explanation for its decision to withdraw of the 1977
NOOHs makes clear that, in deciding to withdraw those notices and defer Withdrawal
Proceedings, the Agency was invoking the same type of discretion that was at issue in Chaney.
Jan. Barcelo Decl. Ex. L. The Supreme Court’s recognition in Chaney that agencies have the
discretion to allocate resources is particularly relevant here. 7 See Chaney, 470 U.S. at 831.
FDA has determined that its limited resources are “best spent” by pursuing voluntary reform in
the first instance, rather than pursuing inevitably lengthy and expensive withdrawal proceedings,
Jan. Barcelo Decl. Ex. I at 3, Ex. J at 2-3 (citing examples), and that pursuing the Withdrawal
Proceedings could force FDA to defer and possibly scale back other regulatory efforts pertaining
to the drug supply and human health. (Second Flynn Decl. ¶¶ 4, 8, 10-12.) But the Agency
cannot be forced to redirect appropriated funds in order to pursue Plaintiffs’ own enforcement
agenda. See, e.g., Cobell v. Norton, 428 F.3d 1070, 1076 (D.C. Cir. 2005) (“judgment about the
allocation of scarce resources” is a “classic reason[ ] for deference to administrators”); Sierra
Club v. Whitman, 268 F.3d 898, 902-03 (9th Cir. 2001) (agency action held unreviewable in part
because of need for agency to focus resources where they might be most effective); see also
Natural Res. Def. Council, Inc. v. SEC, 606 F.2d 1031, 105 (D.C. Cir. 1979) (agency is “allowed
to be master of its own house” because it “alone is cognizant of the many demands on it, its

7

All of the reasons the Chaney Court gave for applying a presumption of non-reviewability
apply here, and should operate to protect FDA’s ability to decide on the most desirable means of
exercising its authority. Those reasons are: (1) more deference is generally due to agency
decisions that “involves a complicated balancing of a number of factors which are peculiarly
within [the agency’s] expertise,” 470 U.S. at 831; (2) “when an agency refuses to act it generally
does not exercise its coercive power over an individual’s liberty or property rights, and thus does
not infringe upon areas that courts often are called upon to protect,” id. at 832; and (3) decisions
analogous to “the decision of a prosecutor in the Executive Branch not to indict” are generally
owed substantial deference. Id.
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limited resources, and the most effective structuring and timing of proceedings to resolve those
competing demands”). These considerations will further enhance FDA’s prospects on appeal.8
C. The Government Will Be Irreparably Injured Absent a Stay
The Court should also grant a stay because compliance with the March 22 Order would
irreparably harm FDA. Compliance would require the Agency to immediately devote substantial
resources to Withdrawal Proceedings that the Court of Appeals may determine are unnecessary.
In the meantime, FDA would have diverted resources away from other Agency programs that are
important to FDA’s public health mission, including its new regulatory strategy to address
antimicrobial resistance.
One of the most resource-intensive parts of the Withdrawal Proceedings is the initial
step—the re-issuance of the NOOHs.9 (First Flynn Decl. ¶¶ 8-16.) FDA anticipates that the
process of updating and reissuing the NOOHs will take 11 to 17 months. (Id. ¶ 16.)
Accordingly, by the time the appeal is decided, many (if not all) of the resources needed to
prepare the revised NOOHs will likely have been expended.
The quantity of potentially wasted resources would be substantial, whether expressed
monetarily or in terms of the resulting inability to assign expert personnel to other important
8

Moreover, because FDA has now resolved the 1977 NOOHs by withdrawing them, there
remains no live dispute between the parties regarding FDA’s alleged failure to conclude such
proceedings, and Plaintiffs’ request for an order compelling FDA to complete the Withdrawal
Proceedings should properly have been dismissed as moot. See, e.g., McBryde v. Comm. to
Review Circuit Council Conduct and Disability Orders of the Judicial Conference of the United
States, 264 F.3d 52, 55 (D.C. Cir. 2001) (“If events outrun the controversy such that the court
can grant no meaningful relief, the case must be dismissed as moot.”); Natural Res. Def. Council,
Inc. v. Nuclear Regulatory Comm’n, 680 F.2d 810,814-15 (D.C. Cir. 1982) (finding a case moot
because the court “can hardly order the NRC at this point to do something that it has already
done.”).
9

Although the March 22 Order characterizes such an update as optional, see Slip op. at 54,
FDA has determined that it could not proceed with the Withdrawal Proceedings without first
updating those NOOHs. (First Flynn Decl. ¶¶ 9-10.)
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FDA work. Reissuing the NOOHs will take the efforts of over a dozen FDA staff, several of
whom would be senior scientists spending substantial amounts of time on the project. (Id. ¶¶ 1116.) These employees would be taken away from other duties, including drug review, scientific
research, antimicrobial resistance monitoring activities, post-approval drug monitoring activities,
and enforcement activities. (Id. ¶¶ 6, 11); see also infra pp. 16-18.
These diverted resources could not be recaptured if FDA prevails on appeal. On the other
hand, if a stay is granted and FDA has the opportunity to pursue its preferred regulatory strategy,
revised NOOHs would only be required for whatever drugs (if any) FDA decides warrant
withdrawal proceedings after FDA has exhausted its efforts to encourage voluntary reform.
Indeed, even if Plaintiffs prevail on the appeal and establish that FDA has a duty to proceed with
the Withdrawal Proceedings, such proceedings may not be necessary if, as FDA expects, its
voluntary strategy is successful. In such a circumstance there would be no need for FDA to reissue NOOHs and launch adversarial proceedings because drug sponsors could by then have
committed to withdrawing their growth-promotion approvals voluntarily.
FDA also expects that the potentially unnecessary expenditure of resources to reinitiate
the 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, to the detriment of the public health. See Ark. Peace Ctr. v. Ark. Dep’t of Pollution
Control, 992 F.2d 145, 147 (8th Cir. 1993) (finding irreparable harm sufficient to grant a stay
pending appeal where the lack of a stay may negatively affect an agency’s ability to fulfill its
mission, and the “public interest in protecting the environment”); James River Flood Control
Ass’n v. Watt, 680 F.2d 543, 544 (8th Cir. 1982) (granting a stay pending appeal where

15

Department of the Interior (“DOI”) had shown that without a stay it may suffer irreparable harm
because without a stay DOI’s efforts to begin a project would be delayed).
In particular, reinitiating the Withdrawal Proceedings will compromise FDA’s ability to
finalize and implement its current plan to end the use of Medically Important Antimicrobials in
animals for growth promotion uses, because allocating resources to the Withdrawal Proceedings
will divert CVM’s resources away from finalizing and implementing its proposed strategy.
(Second Flynn Decl. ¶¶ 4, 8.) If the strategy set forth in GFI 209 and Draft GFI 213 is
sidetracked, FDA believes that its ultimate goal of withdrawing growth promotion indications for
the approximately 161 Medically Important Antimicrobials will be delayed. (Id. ¶ 8.)
Indeed, FDA’s proposed strategy, as described in GFI 209 and Draft GFI 213, is designed
specifically to reduce the misuse and overuse of antibiotics in animals that are contributing to the
development of antimicrobial resistance in the most quick and efficient manner possible. (Id.
¶ 7.) This approach was formulated in part in response to the Agency’s experience in attempting
to withdraw the drug Baytril (an antibiotic drug product in the fluoroquinolone class) for use in
poultry because of concerns about antimicrobial resistance. (Id. ¶¶ 4-5.) Given the vast time and
expense required to withdraw just one drug approval, the Agency concluded that it might not be
practical to seek to withdraw involuntarily the remaining approximately 161 individual approved
applications covering growth promotion uses for Medically Important Antimicrobials, which
includes the 73 NOOH Products. (Id. ¶¶ 2, 5); see also Second Flynn Decl. Ex. A at 13-17;
Second Flynn Decl. B at 18-22; Jan. Barcelo Decl. Ex. I at 3-4; Jan. Barcelo Decl. Ex. J at 2-4.
Because FDA determined that such involuntary withdrawal proceedings would take many years
to complete, FDA formulated its alternative strategy, which would focus first on eliminating the
injudicious use of such drugs voluntarily, with the potential for more compulsory regulatory

16

action later, if needed. (Second Flynn Decl. ¶ 5); see also Second Flynn Decl. Ex. C at7; Jan.
Barcelo Ex. I at 4; Jan. Barcelo Decl. Ex. J at 4. If that alternative regulatory strategy is
successful, its should result in the withdrawal of the applicable drug approvals for growth
promotion within a three-year period after Draft GFI 213 is finalized. (Second Flynn Decl. ¶ 6.);
Second Flynn Decl. Ex. C at 7-8.
The public comment period for Draft GFI 213 closes on July 12, 2012, at which point
CVM scientists will need to assist in the review and analysis of those comments. Although
CVM cannot be sure of the number of comments it will receive, when GFI 209 was first issued
as a draft guidance in 2010, FDA received approximately 1,200 distinct comments from
individuals or organizations and more than 100,000 comments as part of “write-in” campaigns.
(Second Flynn Decl. ¶ 9.) After completing the analysis of those public comments, CVM’s
scientists would next be involved in the process preparing a final version of the guidance. If this
work is delayed, it will slow the completion and implementation of Draft GFI 213, which will, in
turn, delay the withdrawal of growth promotion indications for all of the approximately 161
Medically Important Antimicrobials.
CVM also expects that, consistent with GFI 209 and Draft GFI 213, some drug sponsors,
in connection with withdrawing their approvals for growth promotion indications, will seek
approvals for legitimate new therapeutic indications at the same time. (First Flynn Decl. ¶ 28;
Second Flynn Decl. ¶ 12). CVM’s dedication of substantial resources to the Withdrawal
Proceedings could delay its review of such new animal drug applications. (First Flynn Decl. ¶
27; Second Flynn Decl. ¶ 12.) FDA is concerned that, “[i]f the review of new drug applications
submitted pursuant to GFI 209 and Draft GFI 213 is delayed because CVM personnel are
committed to working on Withdrawal Proceedings,” drug sponsors may be discouraged from

17

participating in the proposed voluntary program, which could cripple FDA’s enforcement plan.
(First Flynn Decl. ¶ 27.)
Finally, the dedication of resources to prepare new NOOHs would also have negative
effects on other programs that are important to public health generally, and the issue of
antimicrobial resistance specifically. For instance, many of the employees from CVM’s Office
of Research who would be involved in the Withdrawal Proceedings would be diverted from
working on implementing the National Antimicrobial Resistance Monitoring System
(“NARMS”), which is a national public health surveillance system that tracks antibiotic
resistance in foodborne bacteria. (Id. ¶ 26.) Diversion of resources from the NARMS program
would delay the preparation of NARMS data reports and the dissemination of important
information on antimicrobial resistance. Complying with the March 22 Order also will hinder
CVM’s ongoing efforts to implement the NARMS Strategic Plan (Second Flynn Decl. ¶¶ 10-11),
which includes plans for important enhancements to the design of the program.
Ultimately, because of these various ways in which FDA’s regulatory goals will be
compromised by the diversion of resources to pursue the Withdrawal Proceedings that may, after
the appeal, no longer be required and that the Government would not be able to recoup, the
Government will suffer irreparable harm if a stay is not granted.
D. Issuance of a Stay Will Not Substantially Injure Plaintiffs and Is in the Public Interest
Although the Government would suffer substantial injury without a stay, neither
Plaintiffs nor the public as a whole would suffer such injury if a stay is granted. Indeed, the
public would benefit from the grant of a stay because FDA—the agency tasked with regulating
animal drug safety—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

18

regulatory program described in GFI 209 and Draft GFI 213. See supra p. 16. As described in
more detail above, the pursuit of Withdrawal Proceedings now would compromise the Agency’s
pursuit of that preferred strategy.
One important reason why the grant of a stay would align with the public interest is that
FDA’s preferred regulatory strategy covers a much broader set of drugs than contemplated by the
March 22 Order. The Withdrawal Proceedings would be aimed at withdrawing growth
promotion indications for only the 73 NOOH Products, but FDA’s preferred strategy as set forth
in GFI 209 and Draft GFI 213 would seek to achieve that same goal with respect to all of the
approximately 161 Medically Important Antimicrobials (which include the NOOH Products).
(Second Flynn Decl. ¶ 4). Furthermore, the unnecessary expenditure of public funds and
resources is not in the public interest. See supra pp. 14-15; accord James River, 680 F.2d at 54445 (the public interest is served by minimizing “expenditures from the public treasury”); Ruiz v.
Estelle, 650 F.2d 555, 569 (5th Cir. 1981) (“If the State prevails on appeal, the public is best
served by not placing on the State the personnel and monetary burdens of implement[ation of the
court’s order].”).
Plaintiffs are in the same position as members of the public, and therefore will not suffer
substantial harm if a stay is granted. While Plaintiffs may argue that a delay of the Withdrawal
Proceedings will cause harm to themselves and to the public generally, any such harm will be
mitigated by the fact that the strategy set forth in GFI 209 and Draft GFI 213, which FDA is
pursuing already, is specifically designed to address and mitigate those very same harms, and is
intended to do so with respect to a broader group of drugs than would be the subject of the
Withdrawal Proceedings. Accordingly, any purported harm to Plaintiffs caused by deferring

19

Withdrawal Proceedings is strongly outweighed by the public benefit of permitting FDA to
pursue its regulatory goals.
CONCLUSION
For the foregoing reasons, the Court should grant the Government’s motion for a stay of
March 22 Order pending appeal. If the Court denies the Government’s motion for a stay pending
appeal, the Government respectfully requests an interim stay of the Order pending disposition of
the Government’s motion for a stay in the United States Court of Appeals for the Second Circuit.
Dated:

New York, New York
June 1, 2012
Respectfully submitted,
PREET BHARARA
United States Attorney for the
Southern District of New York
Attorney for Defendants

By:

/s/ Amy A. Barcelo
AMY A. BARCELO
ELLEN LONDON
Assistant United States Attorneys
86 Chambers Street, 3rd Floor
New York, New York 10007
Telephone: [phone] / 2737
Facsimile: [phone] / 2702
E-mail: [e-mail]
[e-mail]

OF COUNSEL:
DAVID J. HOROWITZ
Deputy General Counsel

ELIZABETH H. DICKINSON
Chief Counsel, Food and Drug
Division

ERIC M. BLUMBERG
Deputy Chief Counsel, Litigation

THOMAS J. COSGROVE
Associate Chief Counsel

U.S. Department of Health and Human Services
Office of the General Counsel
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White Oak 31 Room 4331
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
(Tel): [phone]

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