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

Filing 77

REPLY MEMORANDUM OF LAW in Support re: 63 MOTION for Summary Judgment on Plaintiffs' First Supplemental Complaint.. 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.
REPLY MEMORANDUM OF LAW IN SUPPORT OF
THE GOVERNMENT’S MOTION FOR SUMMARY JUDGMENT
ON PLAINTIFFS’ FIRST SUPPLEMENTAL COMPLAINT

PREET BHARARA
United States Attorney for the
Southern District of New York
Attorney for Defendant
86 Chambers Street, 5th Floor
New York, New York 10007
Tel.: [phone]
AMY A. BARCELO
Assistant United States Attorney
– Of Counsel

TABLE OF CONTENTS
PRELIMINARY STATEMENT .....................................................................................................1
ARGUMENT ...................................................................................................................................2
I.

THE PETITION RESPONSES ARE NOT SUBJECT TO
JUDICIAL REVIEW ...................................................................................2
A.

B.

The Petition Responses Are Entitled to a Presumption Against
Judicial Review as Decisions Not to Enforce……………………………..4

C.

There is No Other Law to Apply .................................................................9

D.
II.

This Court’s March 22 Order Does Not Control FDA’s Discretion
to Initiate Withdrawal Proceedings for the Remaining Citizen
Petition Drugs ..............................................................................................2

Massachusetts v. EPA Does Not Apply Here ............................................11

FDA’S DENIAL OF THE CITIZEN PETITIONS WAS NOT
ARBITRARY OR CAPRICIOUS ........................................................................11

CONCLUSION ..............................................................................................................................14

TABLE OF AUTHORITIES
CASES
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
Bellevue Hosp. Ctr. v. Leavitt,
443 F.3d 163 (2d Cir. 2006).........................................................................................12
Christianson v. Hauptman,
991 F.2d 59 (2d Cir. 1993).......................................................................................9, 10
Detsel by Detsel v. Sullivan,
895 F.2d 58 (2d Cir. 1990)...........................................................................................12
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) ...................................................................................6
Jerome Stevens Pharms. Inc. v. FDA,
402 F.3d 1249 (D.C. Cir. 2005) .................................................................................6, 7
Lincoln v. Vigil,
508 U.S. 182 (1993) .......................................................................................................5
Massachusetts v. EPA,
549 U.S. 497 (2007) .................................................................................................3, 10
New York Pub. Interest Research Group v. Whitman,
321 F.3d 316 (2d Cir. 2003).......................................................................................3, 4
Overton Park v. Volpe,
401 U.S. 402 (1971) .......................................................................................................9
Riverkeeper, Inc. v. Collins,
359 F.3d 156 (2d Cir. 2004).......................................................................................5, 6
S.E.C. v. Citigroup Global Markets, Inc.,
_ F.3d _, 2012 WL 851807 (2d. Cir. Mar. 15, 2012) ...................................................12

ii

Schering Corp. v. Heckler,
779 F.2d 683 (D.C. Cir. 1985) ...................................................................................6, 7
Schneider v. Feinberg,
345 F.3d 135 (2d Cir. 2003)...........................................................................................9
Vermont Yankee Nuclear Power v. NRDC,
435 U.S. 519 (1978) .....................................................................................................12
STATUTES AND REGULATIONS
5 U.S.C. § 701(a)(2) .........................................................................................................................9
21 U.S.C. § 355 ................................................................................................................................6
21 U.S.C. § 360b(e)(1)........................................................................................................... passim
21 C.F.R. §§ 514.115, 514.200(b) ...................................................................................................4
OTHER AUTHORITIES
77 Fed. Reg. 22247 (Apr. 13, 2012) ................................................................................................1
77 Fed. Reg. 22327 (Apr. 13, 2012) ................................................................................................2
77 Fed. Reg. 22328 (Apr. 13, 2012) ................................................................................................1

iii

PRELIMINARY STATEMENT
As FDA explained in the Petition Responses,1 the Agency has concluded that pursuing
the adversarial adjudications to withdraw the approximately 161 individual licenses at issue in
the Citizen Petitions would not be an effective strategy to promote the public health. Because
the duration and expense of such adjudication would be excessive, FDA is instead implementing
a plan to encourage voluntary industry reform for a period of time, followed by appropriate
further action under the FDCA, if necessary. FDA’s determination is not subject to judicial
review. But even if it were, the Court should defer to FDA’s reasonable exercise of its authority
to select the regulatory process that will most effectively use FDA’s limited resources to protect
public health.
FDA had been developing its enforcement strategy for the past several years, and, on
April 11, 2012, took several important additional steps to implement it. First, FDA finalized
Guidance #209, The Judicious Use of Medically Important Antimicrobial Drugs in FoodProducing Animals, which recommends phasing out the growth promotion uses of medically
important drugs, and phasing in veterinary oversight of therapeutic uses of these drugs. Third
Barcelo Decl. Ex. A; 77 Fed. Reg. 22328 (Apr. 13, 2012). Second, FDA published a draft
proposed Veterinary Feed Directive (“VFD”) regulation, open for public comment, which will
facilitate the needed veterinary oversight. Third Barcelo Decl. Ex. B; 77 Fed. Reg. 22247 (Apr.
13, 2012).
Third, FDA published a draft guidance entitled New Animal Drugs and New Animal Drug
Combination Products Administered in or on Medicated Feed or Drinking Water of FoodProducing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use
1

Abbreviations in this brief are the same as in the Government’s opening brief dated
March 21, 2012 (the “Govt’s Opening Br.”).

Conditions with GFI #209 (“Draft GFI #213”), which when finalized will assist drug companies
in voluntarily removing growth-promotion uses of antibiotics from their FDA-approved product
labels, and which asks drug sponsors to change their products’ marketing status to “VFD” for
remaining therapeutic uses. Third Barcelo Decl. Ex. C; 77 Fed. Reg. 22327 (Apr. 13, 2012). As
Draft GFI # 213 explains, FDA expects that these labeling changes will take up to approximately
three years from the date Draft GFI #213 is finalized, at which point the Agency “will consider
further action as warranted in accordance with existing provisions of the [FDCA],” including, if
necessary, initiating the process for involuntary drug withdrawals under 21 U.S.C. § 360b(e)(1).
Third Barcelo Decl. Ex. C at 7.
For the reasons the Government explained in its Opening Brief, regardless of whether this
Court determines that the decision whether to initiate adversarial administrative proceedings is
unreviewable under Heckler v. Chaney and its progeny, or instead reviews the Petition
Responses under the appropriately deferential arbitrary and capricious standards, the correct
outcome here is the same: FDA should not be compelled to initiate adversarial administrative
proceedings, particularly when the Agency believes that it can achieve the same goals more
quickly and efficiently through other means.
ARGUMENT
I.

THE PETITION RESPONSES ARE NOT SUBJECT TO JUDICIAL REVIEW
A. This Court’s March 22 Order Does Not Control FDA’s Discretion to Initiate
Withdrawal Proceedings for the Remaining Citizen Petition Drugs
Plaintiffs are wrong to argue that this Court’s Opinion and Order dated March 22, 2012

(the “March 22 Order”) (Dkt. No. 70) held that the Petition Responses are subject to judicial
review. Plfs’ Opp. Br. at 3. As an initial matter, although Plaintiffs now seek to compel FDA to
make a “finding” whether the Citizen Petition Drugs are not shown to be safe, the Citizen

2

Petitions themselves requested something different: that FDA actually withdraw approvals for
the Citizen Petition Drugs. See Second Barcelo Decl. Exs. D at 1, E at 1. It was that request
(and not a request for “findings”) that FDA properly addressed (and denied) in the Petition
Responses.
In any event, even if the Citizen Petitions had requested that FDA only make “findings”
with regard to the Citizen Petition Drugs, neither 21 U.S.C. § 360b(e)(1) nor the March 22 Order
addresses FDA’s discretion in deciding whether and when to make such findings. Specifically,
the March 22 Order held no more than that FDA made “findings” that certain uses of penicillins
and tetracyclines in animals feed were “not shown to be safe,” March 22 Order at 45-48, and that
as a result of having made such “findings,” FDA must now initiate formal withdrawal
proceedings for those specific drugs. See id. at 54. Plaintiffs do not (and cannot) contend that
FDA made any statutory “findings” with respect to the remaining (non-penicillin, nontetracycline) Citizen Petition Drugs. Rather than speak to whether and when FDA must
undertake the process of making a “finding” in the first place, the March 22 Order held
specifically that Section 360b(e)(1) provides for what happens after “findings” are made. See,
id. at 29-39.
Accordingly, this case is controlled by New York Pub. Interest Research Group v.
Whitman, 321 F.3d 316 (2d Cir. 2003) (“NYPIRG”), in which the Second Circuit found a statute
to impose a “nondiscretionary obligation” on an agency that “arises [only] after [the agency
makes] a discretionary determination.” 2 321 F.3d at 331. In that case, the EPA was not under

2

Plaintiffs argue that NYPIRG was overruled by decision in Massachusetts v. EPA, Plfs’ Br. at
13 n.2, but as discussed infra, Massachusetts is easily distinguishable on the ground that
itinvolved the denial of a petition for a rulemaking that was based on an agency’s refusal to
assert jurisdiction over the subject matter (i.e., greenhouse gasses). Moreover, if Massachusetts
3

any obligation to perform the “nondiscretionary obligation” because it had declined to undertake
the “discretionary” obligation. Id. Likewise, here, even if the Citizen Petitions had requested
only that FDA make “findings,” whether to undertake to reach such findings is within the
Agency’s discretion; FDA has no “nondiscretionary obligation” to proceed with withdrawal
hearings unless the prerequisite findings are made. See Govt’s Opening Br. at 13-19.
B. The Petition Responses Are Entitled to a Presumption Against Judicial Review as
Decisions Not to Enforce
Withdrawal proceedings under 21 U.S.C. § 360b(e)(1) are enforcement proceedings
within the meaning of Heckler v. Chaney, 470 U.S. 821 (1985). First, they are unmistakably
adversarial, and often are high-stakes, resource-intensive litigations. See, e.g., Jan. Barcelo Decl.
Ex. N. To withdraw an animal drug when a hearing is requested and granted, FDA must hold a
formal, contested proceeding in which the Agency’s Center for Veterinary Medicine (“CVM”)
litigates against the drug sponsors, with CVM seeking and the sponsor opposing withdrawal of
approval. See 21 C.F.R. §§ 514.115, 514.200(b); Jan. Barcelo Decl. Ex. N at 7. Like in Chaney,
the FDA’s decisions whether to initiate and prosecute such adversarial proceedings “involve[] a
complicated balancing of a number of factors which are peculiarly within [the agency’s]
expertise.” Chaney, 470 U.S. at 831.
Indeed, the reasoning of Chaney applies with even greater force here because
proceedings to withdraw drug approvals that result in a determination adverse to the application
holder(s) would serve as a “prelude” to further enforcement action. In Chaney, the Supreme
Court held that administrative proceedings to determine whether a drug product comports with
the requirements of the FDCA are tantamount to enforcement proceedings, because they serve

had actually overruled NYPIRG, the decisions of four other Circuits—the Third, Fifth, Eighth,
and Ninth—would also have been overruled. See NYPIRG, 321 F.3d at 330 n.7.
4

“no purpose apart from serving as a prelude” to other enforcement actions. Chaney, 470 U.S. at
825 n.2; see also Chaney v. Schweiker, No. 81-2265, slip op. at 9 (D.D.C. Aug. 30, 1982),
Second Barcelo Decl. Ex. H; Govt’s Opening Br. at 15-16. And so it is here, for proceedings
leading to the involuntary withdrawal of a mass number of NADAs and ANADAs would be
meaningless if they did not serve as a “prelude” to further FDA enforcement.
Moreover, even if FDA’s decision not to pursue formal drug withdrawal proceedings
were not a traditional “enforcement” decision, Chaney is not limited to such decisions, but rather
identifies factors counseling against judicial review, each of which is present here. Govt’s
Opening Br. at 15-16, n.12. For example, decisions about the allocation of agency resources
indisputably are committed to the agency’s discretion. Govt’s Opening Br. at 12, 15 (citing
Lincoln v. Vigil, 508 U.S. 182 (1993)); Plfs’ Opp. Br. at 9. Plaintiffs’ sole response, that this is
not “a lump-sum appropriations case,” Plfs’ Opp. Br. at 9, avoids the issue, for Plaintiffs never
dispute that drug withdrawal proceedings would consume considerable agency resources that
would otherwise be available to carry out FDA’s public health protection mission.
Plaintiffs’ attempts to cabin the scope of Chaney are not supported by the case law. For
example, the parallels between this case and Riverkeeper, Inc. v. Collins, 359 F.3d 156 (2d Cir.
2004), where the Second Circuit held that judicial review is barred, confirm that Chaney applies
to this case. Plfs’ Opp. Br. at 6. In Riverkeeper, plaintiffs challenged the denial by the Nuclear
Regulatory Commission (“NRC”) of a petition requesting that NRC “condition” an existing
license for two nuclear power plants on the adoption of safety measures that plaintiffs believed
were statutorily required. 359 F.3d at 158. Likewise, here, Plaintiffs petitioned FDA to revise or
revoke existing approvals of the Citizen Petition Drugs based on contentions that the drugs do
not comport with the requirements of the FDCA. See Second Barcelo Decl. Exs. D & E. Thus,

5

as in Riverkeeper, Plaintiffs seek to amend or revoke existing government-granted licenses.
And, like the Second Circuit in Riverkeeper, this Court should find that the Citizen Petitions
were a petition to enforce the law that is subject to Chaney.
Riverkeeper also disposes of Plaintiffs’ argument that Chaney applies only with respect to
enforcement actions against “third parties” engaged in “unlawful activity.” Plfs’ Opp. Br. at 6-7.
The Riverkeeper plaintiffs did not allege that the power plant operator had violated the terms of
its existing license, just as there is no allegation here that the sponsors of the Citizen Petition
Drugs are operating outside the terms and conditions of their FDA-granted NADAs and
ANADAs. Rather, like in Riverkeeper, Plaintiffs here are trying to force changes to the alreadygranted government licenses, with which the licensees (i.e., sponsors) will then be required to
comply. Moreover, because (unlike Riverkeeper) FDA could only withdraw approvals for the
Citizen Petition Drugs if it prevails in adversarial proceedings against the drug sponsors, see
supra at 4, drug withdrawal proceedings under the FDCA possess even more of the essential
characteristics of enforcement proceedings under Chaney than the proceedings in Riverkeeper.
Decisions since Chaney have confirmed FDA’s unreviewable discretion to decline to
commence formal proceedings to enforce the safety and efficacy provisions of the FDCA. See
Jerome Stevens Pharms. 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 from judicial review);3 see also
Schering Corp. v. Heckler, 779 F.2d 683, 686 (D.C. Cir. 1985) (FDA exercised unreviewable
3

Jerome Stevens likewise disposes of Plaintiffs’ argument that the FDCA “separates the
substantive provisions of the Act from its enforcement provisions,” and that Chaney applies only
to the latter. Plfs’ Opp. Br. at 4. As the D.C. Circuit held, FDA’s decisions regarding how to
manage the drug approval process under 21 U.S.C. § 355, which Plaintiffs characterize as a
“substantive” provision of the FDCA, Plfs’ Opp. Br. at 4, are presumed to be unreviewable in
connection with decisions not to enforce the FDCA. See Jerome Stevens, 402 F.3d at 1257.

6

discretion in deferring action while deciding whether product required premarket approval); Int’l
Ctr. for Tech. Assessment v. Thompson, 421 F. Supp. 2d 1, 7 (D.D.C. 2006) (FDA’s decision
whether to require drug application held to be unreviewable exercise of discretion). Since FDA
possesses the unreviewable discretion to allow a product to remain on the market while it
considers whether it is a “drug” under the FDCA, see Schering Corp., 779 F.2d at 686, or
whether a drug is safe and effective, see Jerome Stevens, 402 F.3d at 1258, there is no reason in
logic or law that the Agency does not also have the unreviewable discretion to defer extensive
withdrawal proceedings (and making any formal “finding” whether a drug has not been shown to
be safe) while the FDA engages with drug companies to bring about desired changes voluntarily.
Plaintiffs particularly mischaracterize the Jerome Stevens case in arguing that it pertained
to the exercise of FDA’s discretion to not bring an enforcement action against a company
engaged in a “prohibited act” under subchapter III of the FDCA. 402 F.3d at 1258. There in
fact was no allegation in Jerome Stevens relating to any “prohibited act,” and there was no
request for FDA to initiate an enforcement proceeding in court. Rather, the Jerome Stevens
plaintiff alleged that FDA had unlawfully extended the deadlines for one of its competitors to
submit a new drug application. Id. The D.C. Circuit rejected this argument, finding that the
extension was an “exercise of FDA’s enforcement discretion.” Id.
Nor should the Court accept Plaintiffs’ argument that withdrawal proceedings do not
count as “enforcement” because they would “change the law.” Plfs’ Opp. Br. at 4. Simply
because the terms and conditions of a government license (i.e., the NADAs for the Citizen
Petition Drugs) must be observed does not mean that the withdrawal of such license effects any
change in the parameters or reach of the FDCA. Rather, proceedings to withdraw an NADA or
an ANADA involve the application of existing law to facts adduced at the hearing. If a drug

7

approval is withdrawn entirely, it simply means that the drug may no longer be introduced into
interstate commerce. Moreover, contrary to Plaintiffs’ argument, Pls’ Opp. Br. at 8-9, the fact
that orders approving NADAs are listed in the Code of Federal Regulations to provide public
notice of the approved uses of animal drugs does not convert drug approval proceedings into
rulemakings or the NADAs into legislative rules. See Govt’s Opening Br. at 22 n.22. Indeed,
the FDCA already provides that animal drugs used in animal feed may be used only in strict
accordance with the approved conditions of use as reflected on the product labels, see id. at 4
(citing 21 U.S.C. §§ 360b(a)(1), (4)).
Finally, Plaintiffs do not cite any new authority for their argument that the substance of
the Petition Responses are subject to judicial review. Plfs’ Opp. Br. at 8. A.L. Pharma, Inc. v.
Shalala, 62 F.3d 1484 (D.C. Cir. 1995), involved a challenge to FDA’s approval of an NADA in
the first instance, rather than the denial of a request to withdraw approvals at issue here. A.L.
Pharma, 62 F.3d at 1492 (describing the issue in that case as whether “FDA’s approval of [the
application at issue] was . . . arbitrary and capricious.”). Likewise, Barnes v. Shalala, 865 F.
Supp. 550, 554 (W.D. Wis. 1994), is best understood as no more than a challenge to FDA’s
labeling decisions in connection with a drug approval. See Barnes, 865 F. Supp. at 554
(“Plaintiffs contend that defendants acted improperly in approving Monsanto Corporation’s
application for the use of [a drug] in dairy cows.”). The plaintiffs in that case did not seek
adversarial proceedings to withdraw approvals, but rather challenged FDA’s conclusion that
consumer warnings on products made from cows treated with a particular drug was not required.
Id. at 557. The facts of that case have little relevance here, where Plaintiffs do not challenge
FDA’s original approval of the Citizen Petition Drugs, and instead now seek for FDA to institute
formal adversarial proceedings to revoke drug approvals that have been in effect for decades.

8

C.

There is No Other Law to Apply
Even if the Petition Responses were not subject to the Chaney presumption against

judicial review, the Agency’s decision to defer withdrawal proceedings would still be
“committed to agency discretion by law” under 5 U.S.C. § 701(a)(2) because 21 U.S.C. §
360b(e)(1) does not provide a meaningful standard against which to review FDA’s exercise of its
discretion. Although Plaintiffs assert that the FDCA “provides clear standards by which to
judge” the Petition Responses, Plfs’ Opp. Br. at 11, they do not (and cannot) point to any such
standards. Rather, Plaintiffs’ rely exclusively on this Court’s March 22 Order, which speaks
only to what actions FDA must take after it has made statutory findings.4 See supra pp. 2-3;
Govt’s Opening Br. at 13.
Furthermore, Plaintiffs are incorrect that the “committed to agency discretion by law”
exception is limited to statutes that expressly preclude judicial review. Plfs’ Br. at 10 (citing
Schneider v. Feinberg, 345 F.3d 135, 148-49 (2d Cir. 2003)). Rather, agency decision making is
“committed to agency discretion by law” if the statute, like the FDCA in the eyes of the Supreme
Court, “is drawn so that a court would have no meaningful standard against which to judge the
agency’s exercise of discretion.” Chaney, 470 U.S. at 830 (citing Overton Park v. Volpe, 401
U.S. 402, 410 (1971)); Govt’s Opening Br. at 13.
Nor are the Government’s arguments undermined by Christianson v. Hauptman, 991
F.2d 59 (2d Cir. 1993), Plfs’ Br. at 10-11, where the court held that the National Park Service’s
(“NPS”) refusal to grant an exception to a rule was subject to arbitrary and capricious review
under the APA. The statute (and degree of APA deference) at issue in Christianson has no
4

Plaintiffs’ reference to the general purpose of FDA and the FDCA also does not provide any
basis to review the Petition Responses. Plfs’ Opp. Br. at 12. Indeed, as FDA has explained, it
expects that the approach that it is currently undertaking will more quickly and efficiently fulfill
the aims that Plaintiffs invoke.

9

bearing on whether the FDCA contains provisions limiting the Agency’s discretion as to whether
to initiate drug withdrawal proceedings. Moreover, Christianson, like the most of the rest of the
cases upon which Plaintiffs rely, see Govt’s Opening Br. at 21 n.19 (listing cases), involved the
review of agency rulemaking. See Christianson, 991 F.2d 5at 63 (reviewing decision not to
“process a regulatory change” to an agency rule). That the APA unquestionably provides for the
review of agency rulemakings and denials of petitions for rulemakings has no relevance at all in
this case, which concerns agency discretion not to initiate and conduct a proceeding that is
tantamount to enforcement.
D.

Massachusetts v. EPA Does Not Apply Here
Massachusetts v. EPA, 549 U.S. 497 (2007) does not apply here, because that case held

only that an agency cannot deny a petition for rulemaking based solely on the agency’s incorrect
assertion that it has no jurisdiction. Id. at 511; Govt’s Opening Br. at 21-23. Here, FDA does
not invoke any purported lack of jurisdiction to justify its decision not to act as Plaintiffs wish;
rather, FDA has chosen to pursue a different regulatory strategy while retaining the ability to
commence enforcement proceedings later if necessary. Meanwhile, although Plaintiffs claim, in
error, that the Citizen Petitions were petitions to “change the law,” Plfs’ Opp. Br. at 4, Plaintiffs
do not dispute that drug withdrawal proceedings under the FDCA are adjudications, and
Massachusetts does not speak to denials of requests to initiate enforcement adjudications.
Indeed, Massachusetts supports the Government’s position in this case; the Supreme
Court there explained that agencies that are weighing the exercise of their jurisdiction have
“significant latitude as to the manner, timing, content, and coordination” of its actions. 549 U.S.
at 533; Govt’s Opening Br. at 19-23. To the extent that the Petition Responses are subject to

10

judicial review, that would be the standard that applies here, and FDA’s actions are well within
that latitude. Supra II.
II.

FDA’S DENIAL OF THE CITIZEN PETITIONS WAS NOT ARBITRARY OR
CAPRICIOUS
Even if the Petition Responses were subject to judicial review, the Court should defer to

FDA’s reasonable exercise of its authority to allocate its finite resources effectively and select
the regulatory process that, in FDA’s judgment, will best promote the public health. See Govt’s
Opening Br. at 23-27. As noted above, FDA has recently finalized Guidance for Industry 209
and published Draft GFI #213, which sets forth the Agency’s plan to encourage the withdrawal
of growth-promotion indications and transition the remaining therapeutic indications to “VFD”
status. Third Barcelo Decl. Exs. A & C. Although the recommendations in Draft GFI #213 are
now voluntary, FDA has made clear that, after a proposed three-year implementation period, the
Agency “will consider further action as warranted in accordance with existing provisions of the
[FDCA] for addressing matters related to the safety of approved new animal drugs.” Third
Barcelo Decl. Ex. C at 7. FDA believes that the draft guidance will encourage substantial
progress towards the withdrawal of all growth promotion indications within the three-year
period. FDA also anticipates that this progress would outpace that which could be made were
the Agency to engage in product-by-product withdrawals under 21 U.S.C. § 360b(e)(1).
This Court should defer to FDA’s preferred plan to achieve its public-health goals, which
does not now include adversarial proceedings with respect to the approximately 161 individual
applications covered by the Citizen Petitions. Jan. Barcelo Decl. Ex. I at 3, Ex. J. at 3
(explaining that the recent withdrawal of just one product consumed in excess of five years and
three million dollars). As the Second Circuit recently emphasized, agencies’ decisions on
whether to initiate or compromise adversarial actions in exercise of their regulatory authority are,

11

at a minimum, entitled to substantial deference. See S.E.C. v. Citigroup Global Markets, Inc., _
F.3d _, 2012 WL 851807, *4 (2d. Cir. Mar. 15, 2012) (noting that in light of the “numerous
factors” that affect an agency’s decision to compromise adversarial proceedings, “the scope of a
court’s authority to second-guess an agency’s discretionary and policy-based decision to settle is
at best minimal”); see also Vermont Yankee Nuclear Power v. NRDC, 435 U.S. 519, 543 (1978)
(“[A]dministrative agencies should be free to fashion their own rules of procedure and to pursue
methods of inquiry capable of permitting them to discharge their multitudinous duties.”); Govt’s
Opening Br. at 24.
Nor do Plaintiffs’ criticisms of FDA’s regulatory strategy diminish FDA’s regulatory
discretion or the deference that this Court must afford FDA’s choices. Plfs’ Opp. Br. at 17-19.
As the Second Circuit has explained, a reviewing court has “no license to substitute [its] policy
judgment for that of the agency.” Bellevue Hosp. Ctr. v. Leavitt, 443 F.3d 163, 174 (2d Cir.
2006). Plaintiffs are therefore incorrect to analogize the instant case to Detsel by Detsel v.
Sullivan, 895 F.2d 58 (2d Cir. 1990), where an agency’s assertion about the evidentiary basis of a
rule issued more than 40 years earlier was deemed to be an “educated guess,” id. at 64. Plfs’
Opp. Br. at 17. Rather, FDA’s ongoing effort to reduce the use of antibiotics for promoting
growth is based on a real, present-day expectation that its strategy will succeed, and that
judgment is one that FDA is entitled to make in its substantial discretion.
Even if the Court were improperly to consider Plaintiffs’ purported “evidence” that
FDA’s strategy is unlikely to succeed, that “evidence” is irrelevant, and insufficient to support
disturbing the Petition Responses. Specifically, Alpharma, LLC’s 2010 reaction to Draft
Guidance 209, Bernard Decl. Ex. D, is irrelevant because that company no longer exists. See
Third Barcelo Decl. Ex. D. Comments from the American Farm Bureau Federation also from

12

2010, Bernard Decl. Ex. E, have no bearing on the likelihood that drug sponsors will comply
with FDA’s latest recommendations, especially because that organization represents farmers, and
not drug companies. See Third Barcelo Decl. Ex. E. And, although the 2010 comments by the
Animal Health Institute (“AHI”) do reflect some concerns with FDA’s planned approach, the
AHI at the same time expressed “general agreement” with FDA’s proposed criteria for using
antimicrobial drugs in animal feed, and it “agree[d] [that] veterinary involvement is important in
assuring these uses are judicious.” Bernard Decl. Ex. C at 8. Last week, moreover, in response
to FDA’s publication of the new guidance documents and the proposed VFD regulation, AHI
issued a statement announcing its continued support for FDA’s approach, and in particular,
stated that “[i]mplementation of [FDA’s] policy means all medically-important antibiotics used
in animal agriculture will be used only for therapeutic purposes—disease treatment, control and
prevention—under the supervision of a licensed veterinarian.” Third Barcelo Decl. Ex. F.
Finally, as noted, FDA’s current strategy to encourage voluntary compliance is only a
first step. If some drug companies fail to voluntarily withdraw growth-promotion indications
from their products, FDA reasonably expects that its current approach at a minimum will have
made substantial progress in reducing the number of companies that may be the targets of
enforcement action in the future, thereby pursuing its priorities in a resource-efficient manner,
and permitting FDA to prioritize deployment of its limited enforcement resources to products or
sponsors that prove unresponsive to the voluntary initiative, and that, in FDA’s judgment, are
appropriate targets of withdrawal proceedings. Govt’s Opening Br. at 27.

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CONCLUSION
For the foregoing reasons, the Court should grant summary judgment in favor of the
Government.
Dated: New York, New York
April 16, 2012
Respectfully submitted,
PREET BHARARA
United States Attorney
Southern District of New York
/s/ Amy A. Barcelo
By: AMY A. BARCELO
Assistant United States Attorney
86 Chambers Street
New York, New York 10007
Tel.: [phone]
Fax: [phone]
Email: [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
White Oak 31 Room 4331
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
(Tel): [phone]

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