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

Filing 74

MEMORANDUM OF LAW in Opposition re: 63 MOTION for Summary Judgment on Plaintiffs' First Supplemental Complaint. and Reply in Supp. of 56 Pls.' Mot. for Summ. J. on Third Claim for Relief. Document filed by Center For Science In The Public Interest, Food Animal Concerns Trust, Natural Resources Defense Council, Inc., Public Citizen, Inc., Union Of Concerned Scientists, Inc.. (Sorenson, Jennifer)

IN THE UNITED STATES DISTRICT COURT
FOR THE 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,
)
)
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.
)

11 CIV 3562 (THK)
ECF Case

OPPOSITION TO THE GOVERNMENT’S MOTION FOR SUMMARY JUDGMENT
AND REPLY IN SUPPORT OF PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT
ON THEIR THIRD CLAIM FOR RELIEF
Mitchell S. Bernard (MB 5823)
Natural Resources Defense Council, Inc.
40 West 20th Street
New York, New York 10011
[phone]
[phone] (fax)
[e-mail]

Avinash Kar, admitted pro hac vice
Jennifer A. Sorenson, admitted pro hac vice
Natural Resources Defense Council, Inc.
111 Sutter Street, 20th Floor
San Francisco, California 94104
[phone]
[phone] (fax)
[e-mail]; [e-mail]
Counsel for Plaintiffs

Dated: April 2, 2012

TABLE OF CONTENTS
TABLE OF AUTHORITIES .......................................................................................................... ii
INTRODUCTION .......................................................................................................................... 1
ARGUMENT .................................................................................................................................. 2
I.

FDA’s Denials of the Citizen Petitions Are Subject to Judicial Review ............................ 2
A.

No Presumption of Unreviewability Applies .......................................................... 2
1.

Proceedings to Withdraw Approval of an Animal Drug Are Not
Enforcement Actions Committed to FDA’s Discretion .............................. 2
a.
b.

2.
B.

This Court Has Held that Withdrawal Proceedings Are Not
Committed to FDA’s Discretion ..................................................... 3
Withdrawal Proceedings Are Not Enforcement Actions ................ 3

This Is Not a Lump-Sum Appropriation Case ............................................ 9

The Petition Denials Are Reviewable Because There Is Law to Apply ................. 9
1.
2.

II.

The Food and Drug Act Provides Law to Apply ........................................ 9
Massachusetts v. EPA Applies to this Case .............................................. 13

The Petition Denials Are Arbitrary, Capricious, and Not in Accordance with Law .........14
A.

Even under a Deferential Standard of Review, the Petition Denials Are
Invalid under Massachusetts v. EPA ..................................................................... 14

B.

FDA Admits that the Challenged Drug Uses Pose a Threat to Human Health .... 15

C.

FDA Has Offered No Evidence that Voluntary Measures Will Be Effective ...... 17

CONCLUSION ............................................................................................................................. 19

i

TABLE OF AUTHORITIES
CASES
Abbott Labs. v. Gardner,
387 U.S. 136 (1967) .........................................................................................................2, 9
A.L. Pharma, Inc. v. Shalala,
62 F.3d 1484 (D.C. Cir. 1995) ............................................................................................8
Barnes v. Shalala,
865 F. Supp. 550 (W.D. Wis. 1994) ....................................................................................8
Bowen v. Am. Hosp. Ass’n,
476 U.S. 610 (1986) ...........................................................................................................17
Brock v. Cathedral Bluffs Shale Oil Co.,
796 F.2d 533 (D.C. Cir. 1986) .............................................................................................9
Christianson v. Hauptman,
991 F.2d 59 (2d Cir. 1993)...........................................................................................10, 11
Citizens to Pres. Overton Park, Inc. v. Volpe,
401 U.S. 402 (1971) ...........................................................................................................10
Cutler v. Hayes,
818 F.2d 879 (D.C. Cir. 1987) .............................................................................................5
Detsel by Detsel v. Sullivan,
895 F.2d 58 (2d Cir. 1990)...........................................................................................17, 18
Drake v. FAA,
291 F.3d 59 (D.C. Cir. 2002) .........................................................................................2, 10
Heckler v. Chaney,
470 U.S. 821 (1985) .................................................................................................. passim
Int’l Ctr. for Tech. Assessment v. Thompson,
421 F. Supp. 2d 1 (D.D.C. 2006) .........................................................................................5
Jerome Stevens Pharms., Inc. v. FDA,
402 F.3d 1249 (D.C. Cir. 2005) ...........................................................................................5
Lincoln v. Vigil,
508 U.S. 182 (1993) .............................................................................................................9

ii

Massachusetts v. EPA,
549 U.S. 497 (2007) .........................................................................................12, 13, 14, 15
N.Y. Pub. Interest Research Grp. v. Whitman,
321 F.3d 316 (2d Cir. 2003)...........................................................................................7, 13
Nuclear Info. Res. Serv. v. Nuclear Regulatory Comm’n,
969 F.2d 1169 (D.C. Cir. 1992) ...........................................................................................7
Riverkeeper, Inc. v. Collins,
359 F.3d 156 (2d Cir. 2004).............................................................................................6, 7
Schering Corp. v. Heckler,
779 F.2d 683 (D.C. Cir. 1985) .............................................................................................5
Schneider v. Feinberg,
345 F.3d 135 (2d Cir. 2003)...............................................................................................10
Sec’y of Labor v. Twentymile Coal Co.,
456 F.3d 151 (D.C. Cir. 2006) .............................................................................................8
Sierra Club v. Whitman,
268 F.3d 898 (9th Cir. 2001) ...............................................................................................7
Speed Mining, Inc. v. Fed. Mine Safety & Health Review Comm’n,
528 F.3d 310 (4th Cir. 2008) ...............................................................................................8
STATUTES
1 C.F.R. § 8.1 ...................................................................................................................................9
10 C.F.R. § 2.206 ........................................................................................................................6, 7
10 C.F.R. § 73.51 .............................................................................................................................7
10 C.F.R. § 73.55 .............................................................................................................................7
21 C.F.R. § 10.25(a).......................................................................................................................13
21 C.F.R. § 10.45(d) ......................................................................................................................13
21 C.F.R. §§ 520-529 .......................................................................................................................9
21 C.F.R. § 558 ................................................................................................................................9
5 U.S.C. § 701(a)(2) ...............................................................................................................2, 9, 10
iii

21 U.S.C. § 321(p) ...........................................................................................................................5
21 U.S.C. §§ 331-337 ......................................................................................................................4
21 U.S.C. § 331 ............................................................................................................................4, 5
21 U.S.C. § 332 ................................................................................................................................4
21 U.S.C. § 333 ................................................................................................................................4
21 U.S.C. §§ 351-360ccc-2 ..............................................................................................................4
21 U.S.C. § 351 ................................................................................................................................4
21 U.S.C. § 352 ................................................................................................................................4
21 U.S.C. § 355 ................................................................................................................................4
21 U.S.C. § 360b(a)(1) .....................................................................................................................4
21 U.S.C. § 360b(b)(2) ................................................................................................................8, 9
21 U.S.C. § 360b(e)(1) .......................................................................................................11, 12, 14
21 U.S.C. § 360b(e)(1)(B) .............................................................................................................16
21 U.S.C. § 360b(i) ..........................................................................................................................9
21 U.S.C. § 360b(m)(1)(C) ..............................................................................................................9
21 U.S.C. § 360b(n) .........................................................................................................................9
21 U.S.C. § 393(b)(1)-(2) ..............................................................................................................12
42 U.S.C. § 2201(b) .........................................................................................................................7
42 U.S.C. § 7509(b) .........................................................................................................................7
42 U.S.C. § 7521(a)(1) .............................................................................................................12, 14
42 U.S.C. § 7661a(i)(1)....................................................................................................................7
44 U.S.C. § 1510 ..............................................................................................................................9
49 U.S.C. § 46101(a)(3) .................................................................................................................10
iv

OTHER AUTHORITIES
38 Fed. Reg. 9811 (Apr. 20, 1973) ................................................................................................18

v

INTRODUCTION
Although it concedes that the “injudicious use of antibiotics in animals should stop,” the
Government now contends that the U.S. Food and Drug Administration (FDA) exercised
unreviewable enforcement discretion when it denied plaintiffs’ citizen petitions, which urged the
agency to withdraw approvals for nontherapeutic uses of medically important antibiotics in
livestock. Defendants wrongly conflate two agency functions: (1) FDA’s broad discretion to
sanction regulated parties for violations of the Federal Food, Drug, and Cosmetic Act (Food and
Drug Act) and (2) its statutory obligation to determine which animal drugs are safe for human
health and to rescind approval for drugs that are not shown to be safe. This Court has already
held that the Food and Drug Act requires FDA to withdraw approval of animal drugs that it finds
are not shown to be safe. Because Congress has provided clear standards against which to judge
FDA’s conduct, the petition denials are subject to judicial review under the Administrative
Procedure Act (APA).
The petition denials are not in accordance with law because they rely on reasoning
divorced from the text of the Food and Drug Act. Rather than reviewing the scientific evidence
petitioners presented and then determining whether the challenged drug uses are safe for human
health under the Act, FDA denied the petitions in favor of an unenforceable plea for industry
cooperation. This violated the APA. Moreover, the administrative record FDA has tendered
reveals not a shred of evidence that efforts to promote voluntary reform will be effective. The
lack of such evidence renders the petition denials arbitrary, in further violation of the APA. For
these reasons, plaintiffs seek an order vacating the denials and remanding the matter to FDA with
instructions to address the petitions promptly on their merits.

1

ARGUMENT
I.

FDA’s Denials of the Citizen Petitions Are Subject to Judicial Review
A.

No Presumption of Unreviewability Applies

The APA “embodies a ‘basic presumption of judicial review.’” Drake v. FAA, 291 F.3d
59, 70 (D.C. Cir. 2002) (quoting Abbott Labs. v. Gardner, 387 U.S. 136, 140 (1967)).
Nonetheless, review is precluded when the challenged agency action has been “committed to
agency discretion by law.” 5 U.S.C. § 701(a)(2). In interpreting this provision, the Supreme
Court has concluded that “certain categories of administrative decisions, including refusals to
take enforcement actions, are presumptively outside the bounds of judicial review.” Drake, 291
F.3d at 70 (citing Heckler v. Chaney, 470 U.S. 821, 831-34 (1985)). A presumption of
unreviewability does not apply in this case because proceedings to withdraw approval of animal
drugs are neither enforcement actions nor decisions allocating lump-sum appropriations.
1.

Proceedings to Withdraw Approval of an Animal Drug Are Not
Enforcement Actions Committed to FDA’s Discretion

Although the word “enforcement” never appeared in the Government’s summary
judgment briefing on plaintiffs’ First Claim for Relief—seeking to compel FDA to complete
withdrawal proceedings for penicillin and tetracyclines in animal feed—the main thrust of the
Government’s brief on plaintiffs’ Third Claim is that proceedings to withdraw approval of an
animal drug are “enforcement” actions committed to the agency’s discretion. See Mem. in Supp.
of the Government’s Mot. for Summ. J. on Pls.’ First Supplemental Compl. and in Opp’n to Pls.’
Second Mot. for Summ. J. (Gov’t Opp’n Br.) 1-2, 5, 10, 13-16, 27, Mar. 21, 2012 (Dkt. 64). This
late-breaking argument fails for two reasons: First, this Court has already held that FDA has a
nondiscretionary duty to commence withdrawal proceedings when it finds that a previously
approved animal drug is no longer shown to be safe. Second, withdrawal proceedings are

2

fundamentally different from enforcement actions. In approval and withdrawal proceedings,
FDA prescribes which drug uses are lawful. It enforces those prescriptions, and other substantive
requirements of the law, in separate enforcement actions. No enforcement action is implicated
here.
a.

This Court Has Held that Withdrawal Proceedings Are Not
Committed to FDA’s Discretion

FDA contends that withdrawal proceedings are entirely discretionary, see Gov’t Opp’n
Br. 16-17 n.13, but this Court has held otherwise: “[T]he statute unambiguously commands the
Secretary to withdraw approval of any new animal drug that he finds is not shown to be safe,
provided that the sponsor of the animal drug has notice and an opportunity for a hearing.” Mem.
Op. & Order (Order) 29, Mar. 22, 2012 (Dkt. 70); see also id. at 33-34 (holding that the Food
and Drug Act “requires the Secretary to issue notice and an opportunity for hearing whenever he
finds that a new animal drug is not shown to be safe”). The Court ordered FDA to initiate and
conclude withdrawal proceedings for penicillin and tetracyclines in animal feed, in accordance
with the agency’s previous findings that these drug uses have not been shown to be safe. Id. at
54. The Government’s argument that withdrawal proceedings are committed to FDA’s discretion
runs counter to the Court’s Order. 1
b.

Withdrawal Proceedings Are Not Enforcement Actions

Additionally, withdrawal proceedings are not enforcement actions. The cases cited by the
Government demonstrate that the purpose of an enforcement action is to hold a regulated party
accountable for a violation of existing law. This case is different, as FDA itself points out:
“There is no allegation that any drugs at issue in this litigation are not new animal drugs that are

1

Because the citizen petitions covered medically important antibiotics in addition to
penicillin and tetracyclines, the Court’s Order did not resolve plaintiffs’ Third Claim for Relief.
3

currently sold lawfully pursuant to approved [applications].” Gov’t Opp’n Br. 4. The citizen
petitions did not ask FDA to penalize drug sponsors for marketing unapproved drug products.
Rather, they asked the agency to change the law—to make currently lawful drug uses unlawful.
That is not an enforcement action.
The organization of the Food and Drug Act separates the substantive provisions of the
Act from its enforcement provisions. Subchapter V, “Drugs and Devices,” sets forth the
substantive law concerning the regulation of human drugs, animal drugs, and medical devices—
including the provisions for approval and withdrawal of approval of new animal drug
applications. See 21 U.S.C. §§ 351-360ccc-2 (containing § 360b). Section 355, in Subchapter V,
makes it unlawful to introduce unapproved new drugs into interstate commerce. See id. § 355(a).
Other provisions in Subchapter V define “adulterated” and “misbranded” drugs, id. §§ 351-352,
and an additional provision deems unapproved new animal drugs to be adulterated. See id.
§ 360b(a)(1) (referring to § 351(a)(5), defining “adulterated”).
A separate subchapter, Subchapter III, is entitled “Prohibited Acts and Penalties.” Id.
§§ 331-337. It is Subchapter III that addresses enforcement. For example, section 331
enumerates dozens of specific acts that constitute violations of the statute’s substantive
requirements, including the introduction into commerce of any article “in violation of section . . .
355.” Id. § 331(d). Section 331 classifies adulteration, misbranding, and the introduction of an
adulterated or misbranded drug into commerce as prohibited acts. Id. § 331(a), (b), (k).
Subchapter III sets forth various penalties for these prohibited acts, including imprisonment,
fines, and civil penalties. See id. §§ 332-333.
The Government misapplies the cases it cites in which courts declined to review FDA’s
exercise of its enforcement discretion. In every one of these cases, the question was whether

4

FDA could be required to enforce the Food and Drug Act against a party that had allegedly
committed a prohibited act under Subchapter III. In Chaney itself, prison inmates argued that
their states’ use of certain drugs “for human execution was the ‘unapproved use of an approved
drug’ and constituted a violation of the [Food and Drug] Act’s prohibitions against
‘misbranding.’” 470 U.S. at 823-24; see 21 U.S.C. § 331(k). In the other FDA cases, the
plaintiffs argued that the agency was permitting violations of the Act by allowing drugs—or, in
one case, a genetically modified aquarium fish—to be introduced into interstate commerce
without approved new drug or new animal drug applications. See Jerome Stevens Pharms., Inc.
v. FDA, 402 F.3d 1249, 1257-58 (D.C. Cir. 2005) (challenging FDA’s decision to allow
manufacturers of unapproved drugs three additional years to submit new drug applications);
Cutler v. Hayes, 818 F.2d 879, 882-86, 892 (D.C. Cir. 1987) (challenging FDA’s failure to bring
enforcement proceedings against manufacturers lacking approved new drug applications for
over-the-counter drugs not generally recognized as effective, see 21 U.S.C. § 321(p) (defining
“new drug” as a drug “not generally recognized . . . as safe and effective”)); Schering Corp. v.
Heckler, 779 F.2d 683, 685 (D.C. Cir. 1985) (challenging FDA’s decision temporarily to forgo
an enforcement action against a manufacturer distributing unapproved animal drugs); Int’l Ctr.
for Tech. Assessment v. Thompson, 421 F. Supp. 2d 1, 6-7 (D.D.C. 2006) (challenging FDA’s
decision not to pursue action against a manufacturer marketing a genetically modified aquarium
fish without an approved new animal drug application).
The Government points to several FDA policy documents that, it says, describe the
agency’s enforcement discretion. See Gov’t Opp’n Br. 5 n.7. Like the cases just discussed, these
documents uniformly concern agency efforts to correct or sanction violations of existing
standards. The FDA Regulatory Procedures Manual explains that the agency may issue warning

5

letters “to correct violations of the statutes or regulations.” Ex. B to 2d Decl. of Amy A. Barcelo,
at 1, Mar. 21, 2012 (Dkt. 65-2). The FDA Investigations Operations Manual describes voluntary
industry actions to address “violative” products or conditions, and it explains that “violative
means the product or condition does not comply with the Acts or associated regulations enforced
by the Agency.” Id. Ex. C, at 1 (Dkt. 65-3). Similarly, the Center for Veterinary Medicine
(CVM) Program Policy and Procedures Manual describes educational activities undertaken by
CVM to increase “compliance with the Federal Food, Drug, and Cosmetic Act.” Id. Ex. A, at 1
(Dkt. 65-1). These documents are inapposite because the petitions did not ask FDA to sanction
unlawful activity by a third party; rather, petitioners asked FDA to comply with mandatory duties
imposed on it by the Food and Drug Act.
The Government also cites cases delineating the enforcement discretion of agencies other
than FDA. Like the FDA cases, these all began with a request that the agency take action against
a regulated party that was allegedly not complying with its obligations under existing law. In
Riverkeeper, Inc. v. Collins, 359 F.3d 156 (2d Cir. 2004), the plaintiffs filed a petition under 10
C.F.R. § 2.206, asking the Nuclear Regulatory Commission (NRC) to take “an enforcement
action” against a nuclear power plant. 359 F.3d at 158, 163. FDA misinterprets a footnote in
Riverkeeper to mean that Chaney’s presumption of unreviewability applies even when plaintiffs
seek relief that is “not purely enforcement relief.” 359 F.3d at 166 n.11; see Gov’t Opp’n Br. 11.
The Government reads too much into this footnote, which has no bearing here. The Riverkeeper
court made no general statement about the kinds of cases to which Chaney applies. Rather, after
noting that plaintiffs had waived their argument that they sought relief that was “not purely
enforcement relief,” the court concluded that “the case before us is properly construed under
Chaney as an appeal from the denial of an enforcement action.” 359 F.3d at 166 n.11 (emphasis

6

added); cf. Nuclear Info. Res. Serv. v. Nuclear Regulatory Comm’n, 969 F.2d 1169, 1178 (D.C.
Cir. 1992) (en banc) (holding that agency action on a petition under 10 C.F.R. § 2.206 is
unreviewable only when the petition requests enforcement).
The Riverkeeper plaintiffs sought to compel the NRC to enforce regulations that imposed
certain requirements on licensees. See Riverkeeper, 359 F.3d at 159 nn. 1-2 (describing 10
C.F.R. § 73.55, requiring nuclear plant licensees to take measures to protect the plant from
radiological sabotage, and 10 C.F.R. § 73.51, requiring licensees to ensure that spent-fuel storage
does not present unreasonable safety risks). The statute governing the agency’s conduct granted
the NRC broad discretion to regulate the possession and use of nuclear material as it deemed
“necessary or desirable,” id. at 163 (quoting 42 U.S.C. § 2201(b)), and plaintiffs themselves did
not argue that the statute provided any “‘meaningful standard against which to judge the
agency’s exercise of discretion.’” Id. at 166 (quoting Chaney, 359 F.3d at 166)). This case is
different. Here, the petitions asked FDA to comply with the very specific mandate that the Food
and Drug Act imposes on the agency to withdraw approval for drug uses that it finds are not
shown to be safe. See infra pp. 11-13. No part of the relief sought by petitioners is law
enforcement against third parties. Riverkeeper is inapposite.
The remaining cases cited by FDA all likewise implicate an agency’s discretion to
sanction a third party for violations of existing law: In New York Public Interest Research Group
v. Whitman, 321 F.3d 316, 319, 322 (2d Cir. 2003), plaintiffs requested that the Environmental
Protection Agency (EPA) issue a Notice of Deficiency (NOD) to New York State because the
state had failed adequately to administer its Clean Air Act permitting program. See 42 U.S.C.
§ 7661a(i)(1); id. § 7509(b) (setting forth sanctions that EPA may impose on states after issuing
a NOD). Similarly, Sierra Club v. Whitman, 268 F.3d 898, 901-02 (9th Cir. 2001), involved an

7

alleged violation of the Clean Water Act, and Speed Mining, Inc. v. Federal Mine Safety &
Health Review Commission, 528 F.3d 310, 318-19 (4th Cir. 2008), and Secretary of Labor v.
Twentymile Coal Co., 456 F.3d 151, 156-57 (D.C. Cir. 2006), both turned on the prosecutorial
discretion of the Secretary of Labor to decide whom to cite for a violation of the Federal Mine
Safety and Health Act.
Courts have not applied Chaney in cases in which plaintiffs sought the withdrawal or
suspension of approval of an animal drug, because that type of regulatory action is not
enforcement. In Barnes v. Shalala, 865 F. Supp. 550, 554 (W.D. Wis. 1994), plaintiffs asserted
that FDA should have imposed a labeling requirement when it approved a bovine growth
hormone (rbST), and they sought suspension of approval as a remedy. The court found the action
reviewable because plaintiffs were “not asking the agency to undertake enforcement actions,”
such as “investigat[ing] alleged unapproved uses of rbST.” Id. at 558. They asked “only that the
FDA reconsider the necessity of labeling products containing milk from rbST-treated cows.” Id.;
see also A.L. Pharma, Inc. v. Shalala, 62 F.3d 1484, 1487, 1492 (D.C. Cir. 1995) (reviewing
FDA’s denial of a citizen petition requesting withdrawal of approval of an animal drug, and
remanding to FDA for a fuller explanation of its approval). This Court should reach the same
result.
The fact that approval and withdrawal proceedings can be characterized as adjudications
does not make them enforcement actions. Regardless of the form they take, these proceedings
have a number of legislative aspects. They have future effect, because they establish whether
particular animal drugs are approved to be marketed under the Food and Drug Act. They affect
others in addition to the drug sponsor: for example, manufacturers of generic drugs may submit
“abbreviated” drug applications that reference and rely on already approved applications. See 21

8

U.S.C. § 360b(b)(2), (n). And they result in “regulation[s]” that are published in the Code of
Federal Regulations, see id. § 360b(i); 21 C.F.R. pts. 520-529, 558, in which only agency
pronouncements with “legal effect” may be published. 44 U.S.C. § 1510(a); see 1 C.F.R. § 8.1;
Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d 533, 539 (D.C. Cir. 1986) (Scalia, J.)
(explaining that the Code of Federal Regulations is authorized to contain “only documents
‘having general applicability and legal effect’” (citing 44 U.S.C. § 1510) (emphasis omitted)).
The Government argues that the provision requiring the publication of regulations is “mostly
arcane,” but it admits that these regulations have a legal impact on animal feed manufacturers.
See 21 U.S.C. § 360b(m)(1)(C); Gov’t Opp’n Br. 22 n.22. These legislative characteristics amply
distinguish approval and withdrawal proceedings from enforcement actions, and the Government
has cited no case that suggests otherwise.
2.

This Is Not a Lump-Sum Appropriation Case

The Government’s reliance on Lincoln v. Vigil, 508 U.S. 182, 186 (1993), is misplaced.
See Gov’t Opp’n Br. 15-16. There, the Supreme Court held that, “[l]ike the decision against
instituting enforcement proceedings, . . . an agency’s allocation of funds from a lump-sum
appropriation” is presumptively unreviewable. Id. at 193. This case does not concern the
allocation of funds from a lump-sum appropriation. It concerns FDA’s duty to comply with the
substantive requirements of the Food and Drug Act.
B.

The Petition Denials Are Reviewable Because There Is Law to Apply
1.

The Food and Drug Act Provides Law to Apply

Because no presumption of unreviewability applies, the petition denials are
presumptively reviewable, see Abbott Labs., 387 U.S. at 140, unless the action requested by the
petitions—the withdrawal of approval of animal drugs that present a human health risk—is
“committed to agency discretion by law.” 5 U.S.C. § 701(a)(2). This bar to judicial review “is a
9

‘very narrow exception,’ which applies only ‘in those rare instances where “statutes are drawn in
such broad terms that in a given case there is no law to apply.”’” Drake, 291 F.3d at 70 (quoting
Citizens to Pres. Overton Park, Inc. v. Volpe, 401 U.S. 402, 410 (1971)). As the D.C. Circuit has
explained, Ҥ 701(a)(2) encodes the principle that an agency cannot abuse its discretion . . .
where its governing statute confers such broad discretion as to essentially rule out the possibility
of abuse.” Drake, 291 F.3d at 70.
Courts have found “no law to apply” in cases where the statute at issue gave the agency
“virtually unfettered discretion” to act as it did. Id. at 71. For example, Drake involved a statute
allowing the FAA Administrator to dismiss a complaint against a carrier when she “is of
the opinion that the complaint does not state facts that warrant an investigation.” 49 U.S.C.
§ 46101(a)(3). The court found no law to apply because the statute “gives the FAA virtually
unbridled discretion over such decisions. The only statutory reference point is the
Administrator’s own beliefs.” 291 F.3d at 72. Similarly, in Schneider v. Feinberg, 345 F.3d 135,
148-49 (2d Cir. 2003), the court declined to review compensation calculations made by the
Special Master appointed to administer the September 11 Victim Compensation Fund. The court
concluded that the governing statute “does not guide or limit the Special Master’s discretion on
this point: it expressly allows the Attorney General and the Special Master to adopt all
substantive and procedural regulations necessary to resolve claims, and places the resolution of
claims beyond the reach of judicial review.” Id. at 149.
In contrast, the Second Circuit exercised judicial review over a challenge to a National
Park Service regulation that prohibited seaplanes on Fire Island. Christianson v. Hauptman, 991
F.2d 59, 63 (2d Cir. 1993). The court concluded that Congress had conferred on the Park Service
a broad, but not limitless, grant of authority to manage the Fire Island National Seashore:

10

“Congress sought to limit the scope of the Service’s authority to the environmental preservation
of the area.” Id. at 62-63. The court thus rejected the notion that the Service had “unfettered
authority to manage the area in whatever way it deems appropriate.” Id. at 63.
The Food and Drug Act provides clear standards by which to judge FDA’s denials of the
citizen petitions. This Court has held that the Food and Drug Act “requires the Secretary to issue
notice and an opportunity for a hearing whenever he finds that a new animal drug is not shown to
be safe,” Order 33-34 (citing 21 U.S.C. § 360b(e)(1)), and that “the statute unambiguously
commands the Secretary to withdraw approval of any new animal drug that he finds is not shown
to be safe, provided that the sponsor of the animal drug has notice and an opportunity for a
hearing.” Id. at 29. The Court ordered FDA to initiate and complete withdrawal proceedings for
penicillin and tetracyclines in animal feed. Id. at 54.
Plaintiffs do not presently seek to compel FDA to withdraw approval of the remaining
drugs covered by the petitions. Rather, they ask that FDA confront the petitions on their
substantive merits and determine whether, based on the scientific evidence, the challenged drug
uses are shown to be safe for human health. See Mem. of Law in Supp. of Pls.’ Mot. for Summ.
J. on Their Third Claim for Relief (Pls.’ Opening Br.), at 9, 20, Feb. 21, 2012 (Dkt. 57). The
Government contends that there is no judicially manageable standard by which to evaluate
FDA’s decision not to begin reviewing the safety of a previously approved drug. This
interpretation of FDA’s statutory mandate would grant the agency unfettered discretion to refuse
to make formal safety findings and thus avoid triggering the withdrawal process the statute
requires. The logic of the Government’s argument would place beyond judicial review FDA’s
failure to act even, as here, in the face of unimpeachable evidence that an approved drug use
posed a serious threat to human health. Congress has not granted FDA that unbridled authority.

11

This Court has already held that “[a]ccording to its statutory mandate, the FDA is
responsible for continuously monitoring regulated drugs and reviewing new studies of their
effectiveness and safety.” Order 33 (citing 21 U.S.C. § 393(b)(1)-(2) (setting forth FDA’s
mission to “promote the public health by promptly and efficiently reviewing clinical research
and taking appropriate action on the marketing of regulated products in a timely manner” and to
“protect the public health by ensuring that . . . human and veterinary drugs are safe and
effective”)). FDA does not dispute that the challenged drug uses present a human health threat.
See Gov’t Opp’n Br. 1-2, 25-26. Especially in these circumstances, the agency does not have
boundless discretion to decide when, if ever, to review the safety of a previously approved drug.
The Supreme Court’s decision in Massachusetts v. EPA, 549 U.S. 497 (2007), further
demonstrates the limits of FDA’s discretion in this regard. There, the Court found law to apply in
a section of the Clean Air Act providing that the EPA Administrator “shall” prescribe standards
“applicable to the emission of any air pollutant from any class or classes of new motor
vehicles . . . which in his judgment cause, or contribute to, air pollution which may reasonably be
anticipated to endanger public health or welfare.” 42 U.S.C. § 7521(a)(1) (emphasis added); 549
U.S. at 506. The Massachusetts Court held that, once the agency had responded to a citizen
petition asking it to make such an “endangerment finding,” the agency’s exercise of discretion
was limited to a determination whether the finding was compelled by the available science. See
549 U.S. at 532-34. Likewise, the Food and Drug Act provision for withdrawal of approval of
animal drugs, 21 U.S.C. § 360b(e)(1), predicates a mandatory action on a scientific finding.
When FDA is confronted with a citizen petition that presents scientific evidence showing that

12

nontherapeutic uses of antibiotics in livestock endanger human health, the agency does not have
unbounded discretion to brush the petition aside. 2
2.

Massachusetts v. EPA Applies to this Case

The Government offers no persuasive reason why Massachusetts should not apply here.
Though the Supreme Court confirmed that an agency’s “refusal to initiate enforcement
proceedings is not ordinarily subject to judicial review,” id. at 527, this case does not involve an
exercise of enforcement discretion. See supra pp. 2-9. Just as in Massachusetts, plaintiffs’ claim
arises out of denials of petitions that “the affected part[ies] had an undoubted procedural right to
file in the first instance,” 549 U.S. at 527, and FDA regulations provide that the denial of a
citizen petition is subject to judicial review. See 21 C.F.R. §§ 10.25(a), 10.45(d).
The Government makes much of the distinction between rulemaking and adjudication,
but it does not explain why the applicability of the Court’s analysis in Massachusetts should turn
on that distinction. The only suggestion the Government offers is that judicial review of an
agency’s decision whether to initiate rulemaking is “particularly appropriate” because of the
“legal” and “infrequent” nature of such a decision. Gov’t Opp’n Br. 22 (citing Massachusetts,
549 U.S. at 527). As discussed above, however, the decision whether to approve or withdraw
approval of an animal drug also has prospective legal effect, see supra pp. 8-9, and the
Government concedes that withdrawal proceedings are “relatively uncommon.” Gov’t Opp’n Br.

2

FDA’s reliance on New York Public Interest Research Group v. Whitman, see Gov’t Opp’n
Br. 17, is misplaced for two reasons. First, as noted above, that case involved a request for an
enforcement action. See supra p. 7. There is no indication that the court would have reached the
same result had it not applied a presumption of unreviewability. See 321 F.3d at 331 (finding that
the conclusion that the statute granted EPA discretion “effectively resolve[d]” plaintiffs’
challenge because “an agency’s decision not to invoke an enforcement mechanism provided by
statute is not typically subject to judicial review”). Second, Whitman predates Massachusetts v.
EPA. To the extent that FDA’s interpretation of Whitman were correct, it could not have
survived Massachusetts.
13

1. Moreover, the Court in Massachusetts held that the decision whether to initiate rulemaking in
that case depended on a factual, not a legal, determination: whether greenhouse gases “‘cause, or
contribute to, air pollution which may reasonably be anticipated to endanger public health or
welfare.’” See Massachusetts, 549 U.S. at 506, 532-33 (quoting 42 U.S.C. § 7521(a)(1)). Here,
petitioners ask FDA to make a similar determination: whether the challenged drug uses are
shown to be safe for human health. The analogy between the animal drug withdrawal provision
and the statute at issue in Massachusetts does not fail simply because the scientific findings
contemplated by the two statutes trigger different consequences. See Gov’t Opp’n Br. 20. The
point is that each statute conditions a mandatory agency action on a scientific finding, thereby
limiting the agency’s discretion as well as the justifications it may offer for declining to act.
II.

The Petition Denials Are Arbitrary, Capricious, and Not in Accordance with Law
A.

Even under a Deferential Standard of Review, the Petition Denials Are
Invalid under Massachusetts v. EPA

The “arbitrary and capricious” standard of review is deferential. Even applying that
standard, however, the Supreme Court in Massachusetts invalidated a petition denial very like
the denials before this Court. The Supreme Court concluded that the Clean Air Act provision at
issue, by predicating mandatory action on a scientific finding, directed the agency to “exercise
discretion within defined statutory limits.” Massachusetts, 549 U.S. at 533. Because the agency
denied the petition based on reasons that fell outside of those limits, the Court found the denial
“arbitrary, capricious, . . . or otherwise not in accordance with law.” Id. at 534.
This Court should reach the same conclusion. The Food and Drug Act “unambiguously
commands the Secretary to withdraw approval of any new animal drug that he finds is not shown
to be safe.” Order 29 (citing 21 U.S.C. § 360b(e)(1)). When it is confronted with a citizen
petition presenting evidence that an approved drug use is not shown to be safe, the agency cannot
14

rely on voluntary measures in lieu of making the finding (or, on the merits, determining not to
make the finding) that triggers the withdrawal process. In these circumstances, the agency’s
discretion to decide whether to initiate withdrawal proceedings is limited to a scientific
determination whether the challenged drug uses are shown to be safe for human health. “To the
extent that this constrains agency discretion to pursue other priorities . . . , this is the
congressional design.” Massachusetts, 549 U.S. at 533. Here, FDA denied the petitions without
addressing the scientific evidence petitioners presented. This violated the APA.
B.

FDA Admits that the Challenged Drug Uses Pose a Threat to Human Health

The Government asks this Court to defer to FDA’s “evaluation of scientific information
within the agency’s area of technical expertise,” Gov’t Opp’n Br. 24, but the agency offered no
scientific reasons for denying the petitions. In fact, every statement FDA has made about the
science supports granting the petitions.
The Government admits that “the phenomenon of antimicrobial resistance exists,” that
“antimicrobial resistance poses a threat to public health,” that “the overuse of antimicrobial drugs
in food-producing animals can contribute to the development of antimicrobial resistance,” and
that “FDA should be involved in mitigating the risks posed by antimicrobial resistance.” Id. at 2.
FDA “has acknowledged that it has significant concerns about the potential public health
consequences of misusing and overusing” antibiotics in livestock. Id. at 1. The agency has “made
clear that it does not consider the use of medically important antibiotics for ‘growth promotion’
in animals to be in the interest of public health.” Id. at 2. FDA “agrees that the injudicious use of
antibiotics in animals should stop.” Id. at 25. The Government even concedes that plaintiffs’
argument that “FDA’s pronouncements convey agreement with the premise of the petitions” is
“true in a general sense.” Id. at 26.

15

The administrative record contains similar statements, in addition to the scientific studies
underlying them. In 2003, CVM reported that “[s]cientific evidence demonstrates that the use of
antimicrobial drugs in food-producing animals can result in the development of resistant
bacteria. The resistant bacteria can then be transferred to humans through food.” The report
continues: “Resistance to the antimicrobial drugs needed to treat human illness is a serious public
health threat, whether the resistance develops from inappropriate use of antibiotics in people, use
of antimicrobials in food-producing animals, or other sources.” Administrative Record, at FDA
3067. The petitions cover antibiotics that FDA has categorized as “critically important” or
“highly important” to human medicine. See Ex. K to Decl. of Jennifer A. Sorenson (Sorenson
Decl.), at 2, Oct. 5, 2011 (Dkt. 33-11).
The Government’s litigation position presents this paradox: FDA asks this Court to defer
to the agency’s scientific judgment because that is its area of expertise. Gov’t Opp’n Br. 24-25.
But the evidence proves that FDA’s scientific judgment is that the nontherapeutic use of
antibiotics in livestock is not shown to be safe for human health. This is precisely what the
petitions say. If the Court were to defer to FDA’s scientific judgment, the Food and Drug Act
would require the agency to grant the petitions and commence withdrawal proceedings. Thus,
the Government’s own argument for deference underscores plaintiffs’ claim that the petition
denials were arbitrary.
The agency’s answer is that it has selected voluntary measures as “the best path to
pursue.” Id. at 26. But that is not the path Congress has chosen. FDA’s refusal to make findings
about whether the drug uses covered by the petitions are “shown to be safe” for human health, 21
U.S.C. § 360b(e)(1)(B), is arbitrary, capricious, and not in accordance with law.

16

C.

FDA Has Offered No Evidence that Voluntary Measures Will Be Effective

Even if FDA’s reliance on voluntary measures were a legitimate basis under the statute
for denying the petitions, the petition denials would still be arbitrary and capricious because the
agency has offered no evidence to support its rationale. Given the opportunity, FDA has not
pointed to a single document in a 3,317-page administrative record to justify its stated belief that
voluntary measures will be effective. The Government devoted only three sentences in its brief
to plaintiffs’ argument that such evidence is required, contending simply that FDA need not
provide any evidence, because its “attempts at voluntary reform” are “only a first step.” Gov’t
Opp’n Br. 27. Besides conveying even less faith in voluntary measures than the agency has
previously professed, see Pls.’ Opening Br. 16, the Government’s casual dismissal of plaintiffs’
request for evidence disregards FDA’s obligation to explain the “factual basis for its decision,”
rather than resting on “mere speculation.” Detsel by Detsel v. Sullivan, 895 F.2d 58, 63-64 (2d
Cir. 1990) (quoting Bowen v. Am. Hosp. Ass’n, 476 U.S. 610, 626-27 (1986) (plurality opinion)).
The Government also implies that FDA intends to take some steps that are not voluntary:
“FDA[] plans to regulate the Citizen Petition Drugs’ remaining therapeutic indications by
labeling them ‘VFD’ [Veterinary Feed Directive] for use only under the supervision of a licensed
veterinarian.” Gov’t Opp’n Br. 25. But FDA has made clear, both in the petition denials and in
previous briefing in this case, that the agency will not require drug sponsors to adopt the VFD
label; rather, sponsors will have the option voluntarily to change the status of their products. Ex.
A to Decl. of Mitchell S. Bernard (Bernard Decl.), at 4, Feb. 21, 2012 (Dkt. 59-1) (“FDA intends
to work with sponsors who approach FDA and are interested in working cooperatively with the
Agency . . . to transition medically important antimicrobials currently approved for over-thecounter use in food-producing animals to a marketing status that involves veterinary
oversight . . . .”); Mem. in Supp. of the Government’s Mot. for Summ. J. and in Opp’n to Pls.’
17

Mot. for Summ. J., at 9, Jan. 9, 2012 (Dkt. 41) (“FDA is now working with sponsors to
voluntarily change the status of medically important antimicrobial drugs currently approved for
use in feed from ‘over the counter’ to ‘veterinary feed directive’ (‘VFD’) status.”). As with the
other components of FDA’s “attempts at voluntary reform,” the Government has presented no
evidence that its efforts to encourage drug sponsors voluntarily to opt for VFD status will be
effective in protecting public health.
The Government asserts that “FDA has been actively involved in the area of
antimicrobial resistance for over 40 years.” Gov’t Opp’n Br. 2. In that time, the volume of
antibiotics used annually in U.S. livestock has quadrupled, from 7.3 million pounds in 1970 to
13,067,100 kilograms, or 28.8 million pounds, in 2009. See Antibiotic and Sulfonamide Drugs in
the Feed of Animals, 38 Fed. Reg. 9811, 9812 (Apr. 20, 1973), Sorenson Decl. Ex. D (Dkt. 334); Sorenson Decl. Ex. P, at tbl.1 (Dkt. 33-16). Livestock antibiotic use outstrips human
antibiotic use by a four-to-one ratio. See Pls.’ Statement of Undisputed Material Facts in Supp. of
Mot. for Summ. J. ¶ 12, Oct. 6, 2011 (Dkt. 21). During the last four decades, as the
nontherapeutic use of antibiotics in livestock has proliferated, so have the scientific studies
demonstrating the link between such use and the diminished efficacy of these same antibiotics to
treat human infections. See Order 2-3. In light of these facts, FDA cannot avoid the obligation to
provide a factual basis for the petition denials by labeling its voluntary reform efforts a “first
step.” Gov’t Opp’n Br. 27.
FDA’s failure to offer evidence to support its reliance on voluntary measures underscores
the arbitrary and capricious nature of the petition denials. See Detsel, 895 F.2d at 63-64. The
Government’s citation to summary accounts on FDA’s website of three occasions on which the
agency persuaded drug sponsors voluntarily to discontinue sales of different animal drugs, in

18

different circumstances, does not demonstrate that the same approach is likely to be effective
here. See Gov’t Opp’n Br. 6 n.8. Given the magnitude of the use of antibiotics in livestock, the
pharmaceutical industry’s economic interest in maximizing that use, livestock producers’
economic interest in promoting weight gain and feed efficiency, and the skepticism of the
industry groups that submitted public comments on FDA’s Draft Guidance 209, there is no
reason to believe that FDA’s attempts at voluntary reform will be successful. The Government
has offered none. 3
CONCLUSION
For the reasons detailed above and in their opening brief, plaintiffs urge the Court to
invalidate the petition denials and remand the matter to FDA with instructions promptly to
address the petitions on their merits and determine whether the challenged drug uses are shown
to be safe for human health.

Dated: April 2, 2012

Respectfully submitted,
Mitchell S. Bernard (MB 5823)
Natural Resources Defense Council, Inc.
40 West 20th Street
New York, New York 10011
[phone]
[phone] (fax)
[e-mail]

3

For the reasons set forth in their accompanying Motion to Complete the Administrative
Record, plaintiffs request an order that the administrative record be completed with the industry
comments filed as Exhibits C, D, and E to the Bernard Declaration (Dkt. 59).
19

s/ Jennifer A. Sorenson
Avinash Kar, admitted pro hac vice
Jennifer A. Sorenson, admitted pro hac vice
Natural Resources Defense Council, Inc.
111 Sutter Street, 20th Floor
San Francisco, California 94104
[phone]
[phone] (fax)
[e-mail]; [e-mail]
Counsel for Plaintiffs
Of Counsel for Plaintiff Center for Science
in the Public Interest:
Stephen Gardner (SG 3964)
Center for Science in the Public Interest
5646 Milton Street, Suite 211
Dallas, Texas 75206
[phone]
[phone] (fax)
[e-mail]

20