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

Filing 55

REPLY MEMORANDUM OF LAW in Support re: 40 MOTION for Summary Judgment.. 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 FURTHER SUPPORT OF
THE GOVERNMENT’S MOTION FOR SUMMARY JUDGMENT
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.

PLAINTIFFS’ CLAIM MUST FAIL BECAUSE THEY DO NOT
REQUEST THE COURT TO COMPEL “DISCRETE” ACTION
THAT FDA IS “REQUIRED” TO TAKE ..............................................................2

II.

THERE HAS BEEN NO STATUTORY “FINDING” THAT CAN
COMPEL AGENCY ACTION PURSUANT TO 21 U.S.C. § 360b(e)(1) .............3
A.

BVM’s Issuance of the 1977 NOOHs Was Not a “Finding” Within
the Meaning of Section 360b(e)(1)……………………………………….4
1.

2.

B.

III.

The Plain Language of the FDCA Supports the Government’s
Position ............................................................................................4
BVM’s Decision to Issue the 1977 NOOHs Is Not A Sufficient
Basis to Withdraw the NOOH Products ..........................................6

Statements Made by FDA Officials Outside of the Context of the
NOOH Proceedings Are Irrelevant to the Issues Before the Court ............8

PLAINTIFFS’ CLAIM THAT THE GOVERNMENT IS REQUIRED
TO PURSUE THE 1977 NOOHS EVEN THOUGH IT HAS
WITHDRAWN THEM SHOULD BE DIMISSED AS MOOT………………….9

CONCLUSION ..............................................................................................................................10

TABLE OF AUTHORITIES
CASES
Bowen v. Georgetown Univ. Hosp.,
488 U.S. 204 (1988) .......................................................................................................5
Connecticut ex rel. Blumenthal v. U.S. Dep’t of Interior,
228 F.3d 82 (2d Cir. 2000).............................................................................................4
Lujan v. Nat’l Wildlife Fed’n,
497 U.S. 871 (1990) .......................................................................................................3
NRDC v. EPA,
595 F. Supp. 1255 (S.D.N.Y. 1984)...............................................................................9
Norton v. Southern Utah Wilderness Alliance,
542 U.S. 55 (2004) .....................................................................................................2, 3
Public Citizen v. Nuclear Regulatory Comm.,
901 F.2d 147 (D.C. Cir. 1990) .......................................................................................9
Sterling Drug, Inc. v. Weinberger,
384 F. Supp. 557 (S.D.N.Y. 1974)
affd 509 F.2d 1236 (2d Cir. 1975) .................................................................................5
Thomas v. City of New York,
143 F.3d 31 (2d. Cir. 1998)............................................................................................2
Weinberger v. Hynson, Wescott and Dunning, Inc.,
412 U.S. 609 (1973) .......................................................................................................7
STATUTES AND REGULATIONS
21 U.S.C. § 360b(e)(1)........................................................................................................... passim
5 U.S.C. § 706(1) .........................................................................................................................2, 9
21 C.F.R. § 10.55(b)(2)(i) ................................................................................................................7
21 C.F.R. § 12.80 et seq ...................................................................................................................3
21 C.F.R. § 514.115(b)(3)(ii) .......................................................................................................6, 9
21 C.F.R. § 514.200(b) ................................................................................................................6, 7

ii

ADMINISTRATIVE ADJUDICATIONS
Withdrawal of Approval of the New Animal Drug Application for Enrofloxacin in
Poultry, Docket No. 2000N-1571 (July 27, 2005) ........................................................7
OTHER AUTHORITIES
43 Fed. Reg. 53827 (Nov. 17, 1978)................................................................................................6
48 Fed. Reg. 4554 (Feb. 1, 1983) ....................................................................................................8

iii

PRELIMINARY STATEMENT
Plaintiffs initiated this case with a simple, albeit incorrect claim: that “findings” made by
FDA’s BVM1 34 years ago (in 1977) could require this Court to mandate withdrawals of
approvals for the use of penicillins and tetracyclines for use in animal feed—i.e., the NOOH
Products. In its Opening Brief, the Government demonstrated that Plaintiffs’ claims have no
merit, because an opportunity for a hearing on the proposed drug withdrawals had never been
provided to the sponsors of the NOOH Products as required under the FDCA, and, accordingly,
the Commissioner never made the findings upon which a withdrawal could be based. The
Government also showed that BVM (as opposed to the Commissioner), did not have the
authority to make findings upon which the NOOH Products could be withdrawn. Finally, the
Government explained that any “unreasonable delay” claim seeking to compel hearings has
become moot because the 1977 NOOHs have been withdrawn.
Now, conceding that a straightforward withdrawal of the NOOH Products would be
unlawful under the FDCA, Plaintiffs admit that they are really seeking for this Court to order a
multi-step regulatory campaign against the more than 73 NOOH Products, including a
mandatory update of the 1977 NOOHs, followed by evidentiary hearings (including motions
practice, testimony, oral argument, and post-hearing briefing) and formal Agency findings. But,
as the Supreme Court has established, plaintiffs can seek to compel agency actions only if they
are both “required” and “discrete”; they may not compel broad programmatic relief of the type
now sought by Plaintiffs. Furthermore, Plaintiffs still cannot identify any “finding” by BVM in
1977 that could compel this Court to grant any relief at all. Finally, Plaintiffs have failed to rebut

1

Abbreviations in this brief are the same as in the Government’s opening brief dated
January 9, 2012 (the “Opening Br.”).

FDA’s showing that, because the 34 year-old 1977 NOOHs have been formally withdrawn, any
claim to compel a hearing based on those withdrawn notices is moot.
ARGUMENT
I.

PLAINTIFFS’ CLAIM MUST FAIL BECAUSE THEY DO NOT REQUEST THE
COURT TO COMPEL “DISCRETE” ACTION THAT FDA IS “REQUIRED” TO
TAKE
Plaintiffs concede that they are not entitled to an order compelling FDA to “withdraw its

prior approvals” for the NOOH Products immediately. See Plfs’ Opening Brief at 2, 10. Indeed,
even under Plaintiffs’ theory of the FDCA, currently FDA is not permitted (let alone required) to
withdraw approval for the NOOH Products, see Plfs’ Opp. at 3, 7, for FDA could withdraw such
approvals only “if,” at some later date and after a hearing is held, the Commissioner makes the
required statutory determination set forth in section 21 U.S.C. § 360b(e)(1).2 Plfs’ Opp. at 3, 7;
see also id. at 1, 6. Plaintiffs now concede also that, even had the 1977 NOOHs not been
withdrawn, FDA could not convene hearings to withdraw approvals for the NOOH Products
without first updating the 1977 NOOHs to account for the last 34 years of developments in
scientific research and understanding. Plfs’ Opp. at 20, 22.
The relief that Plaintiffs now seek is neither “required” nor “discrete,” and their claim
under 5 U.S.C. § 706(1) therefore cannot succeed. See Opening Br. at 11 (citing Norton v.
Southern Utah Wilderness Alliance, 542 U.S. 55, 64 (2004) (“SUWA”)). First, there is nothing in
the FDCA or its implementing regulations “requiring” FDA to update 34 year-old withdrawal
proposals. Neither is there any such basis to compel FDA to take any of the numerous additional

2

In light of Plaintiffs’ concessions, this is also now a textbook example of a case that
should be dismissed on ripeness grounds. E.g., Thomas v. City of New York, 143 F.3d 31, 34 (2d
Cir. 1998) (no subject matter jurisdiction exists over a claim that “is based upon contingent
future events that may not occur as anticipated, or indeed may not occur at all,” because such a
claim is not ripe) (internal quotations and citations omitted).
2

steps that would be required to lawfully withdraw any of the 73 or more NOOH Products.3 Such
steps would include, inter alia, FDA’s Center for Veterinary Medicine (“CVM”) (as successor to
BVM) issuing an updated NOOH to provide notice to sponsors of the bases for withdrawal, and
convening a hearing, which would include motions practice, testimony, oral argument, and posthearing briefing. See 21 C.F.R. § 12.80 et seq. (“Hearing Procedures”). Then, assuming CVM
were to initially prevail at the hearing, if the sponsors appealed the outcome, the Commissioner
would need to review the record and make a final determination whether any approvals of the
NOOH Products should be withdrawn. See id. at § 12.120 et seq. (“Initial and Final Decisions”).
In similar situations in the past (where just one drug product was at issue), this process has taken
almost five years. 4 See Barcelo Decl. Ex. I at 3; Barcelo Decl. Ex. J at 3.
Because this long chain of events is plainly neither “required” nor “discrete,” Plaintiffs’
claim constitutes a “broad programmatic attack” on FDA’s regulation of animal drugs like those
that the Supreme Court has held is unavailable under the APA. SUWA, 542 U.S. at 64; accord
Lujan v. Nat’l Wildlife Fed’n, 497 U.S. 871 (1990) (litigants may not bring suit pursuant to the
APA “seek[ing] wholesale improvement of [an agency] program by court decree”).
II. THERE HAS BEEN NO STATUTORY “FINDING” THAT CAN COMPEL AGENCY
ACTION PURSUANT TO 21 U.S.C. § 360b(e)(1)
Even if Plaintiffs’ claim were cognizable under the APA (it is not), it should fail for the
independent reason that Plaintiffs have not identified (and cannot identify) any “finding” by
3

As the Government noted in its brief opposing Plaintiffs’ motion for leave to file a
Supplemental Complaint, Dkt. No. 46, FDA estimates that there are at least 73 approved NOOH
Products for use in animal feed, either alone or in combination with other approved drugs, id. at
6 n.1. This number does not include approvals for the use of the relevant antimicrobial drugs in
water, inclusion of which would likely increase the total by several dozen. Id.
4

Plaintiffs make no attempt to justify (or even explain) the basis for their claim that one
year would be a reasonable period of time for FDA to complete these numerous tasks. There is
no doubt, however, that a one year deadline would be insufficient in light of the five year period
that the enrofloxacin withdrawal consumed. Barcelo Decl. Ex. I at 3; Barcelo Decl. Ex. J at 3.
3

FDA requiring the withdrawal of approval for the NOOH Products pursuant to 21 U.S.C.
§ 360b(e)(1). Opening Br. at 12-21.
A.

BVM’s Issuance of the 1977 NOOHs Was Not a “Finding” Within the Meaning of
Section 360b(e)(1)
1.

The Plain Language of the FDCA Supports the Government’s Position

Plaintiffs are wrong that the rules of grammar require a reading of section 360b(e)(1) that
would deem BVM’s issuance of the 1977 NOOHs, which happened before any statutorily
mandated hearing, to be a “finding” that could compel the withdrawal of the NOOH Products.
See Plfs’ Opp. at 3-5. The plain text of the statute reads as follows:
[t]he [Commissioner] shall, after due notice and opportunity for
hearing to the applicant, issue an order withdrawing approval of
an [animal drug] . . . if the [Commissioner] finds . . . that new
evidence . . . shows that such drug is not shown to be safe.
21 U.S.C. § 360b(e)(1)(B) (emphasis added). Congress’s placement of the phrase “after due
notice and opportunity for hearing” towards the beginning of the sentence conveys its intention
that any of the events described following that phrase (including the Commissioner’s findings)
shall occur only “after” sponsors are granted “due notice and opportunity for hearing.” Opening
Br. at 13-15.
Plaintiffs’ argue that, by placing the phrase “after due notice and opportunity for hearing”
between the words “shall” and “issue,” Congress expressed its intention that the only thing to
happen after a hearing is the issuance of an actual order withdrawing approval (and not any
“findings” based on the hearing). See Plfs’ Opp. at 4. This reading is nonsensical, would
undermine fundamental concepts of due process, and would render the statute’s requirement for
a hearing superfluous. See, e.g., Connecticut ex rel. Blumenthal v. U.S. Dep’t of Interior, 228

4

F.3d 82, 88 (2d Cir. 2000) (“we are required to disfavor interpretations of statutes that render
language superfluous”) (internal quotation omitted).
As Plaintiffs concede elsewhere, where (as here) hearing has been requested and granted,
FDA cannot withdraw approval for the products at issue unless and until the Commissioner
herself has made a final “determination,” based on evidence adduced at the hearing, Plfs’ Opp. at
7.5 What Plaintiffs try to distinguish as a post-hearing “determination,” however, is quite
obviously the “finding” to which section 360b(e)(1) refers. See Opening Br. at 13-15.
Moreover, even if the language of section 360b(e)(1) were ambiguous (it is not), this
Court should defer to FDA’s longstanding interpretation that, when a hearing on a proposed
withdrawal is granted, any “finding” that a drug is unsafe or not shown to be safe can only come
after the hearing.6 See Opening Br. at 12-13, 16-19. This is the clear import of FDA regulations
providing that disputed issues of fact are to be referred for hearings and resolved by the
Commissioner. See id.; see also infra Section II.B.2.

5

Without such a determination, there is no appealable final agency action, which is yet
another reason why the 1977 NOOHs would be an insufficient basis upon which to compel drug
withdrawals. See Opening Br. at 14 n.11 (citing Sterling Drug, Inc. v. Weinberger, 384 F. Supp.
557, 561 (S.D.N.Y. 1974), affd. 509 F.2d 1236 (2d Cir. 1975) (issuance of NOOH is not an
appealable agency decision; appeal to federal court may be taken from the Commissioner’s final
decision).
6

Plaintiffs’ citation of Bowen v. Georgetown Univ. Hosp., 488 U.S. 204 (1988), Plfs’ Opp.
at 15, is inapposite. The Government’s proposed interpretation of section 360b(e)(1) is not a
“novel[]” “litigating position” as was the government’s position in that case. Id. at 212. Rather,
the Government’s “reasoned and consistent,” position is supported by FDA’s “rulings and
administrative practice.” Id. at 212; see also Opening Br. at 16-17. Furthermore, Plaintiffs never
dispute that, even if FDA’s interpretation of the statute were not entitled to Chevron deference (it
is), the less deferential Skidmore deference doctrine would apply. Opening Br. at 18-19 n.17.
5

2.

BVM’s Decision to Issue the 1977 NOOHs Is Not A Sufficient Basis to
Withdraw the NOOH Products

Plaintiffs’ speculation about whether an NOOH could provide a sufficient basis for
withdrawal if the drug sponsors never requested a hearing, Plfs’ Opp. at 5, 10-11, is irrelevant in
this case, where it is undisputed that: (i) numerous drug sponsors requested hearings pursuant to
section 360b(e)(1), 43 Fed. Reg. 53827, 53827 (Nov. 17, 1978) (Barcelo Decl. Ex. G); (ii) the
Commissioner granted those requests for hearings, id. at 53827-28; (iii) those hearings were
never held; and (iv) BVM’s decision to issue the 1977 NOOHs could not form a sufficient basis
to revoke a drug’s approval because hearings were requested, see Opening Br. at 15-16
(describing delegations to BVM and CVM). The Government is not arguing that BVM was not
exercising properly delegated authority when it issued the 1977 NOOHs, but rather that, when
numerous sponsors requested hearings on the proposed withdrawals, BVM was immediately
divested of authority to move forward with such withdrawals on its own.7 Id. The
Commissioner has reserved that authority for herself. Id.
An analogy between FDA’s procedures for drug withdrawals and a court’s procedural
rules is instructive. The issuance of an NOOH by an FDA bureau8 (i.e., BVM or CVM) is
analogous to the filing of a complaint. Like in a civil case, if the sponsor (or “defendant”) does
not appear, the bureau prevails by default. See 21 C.F.R. § 514.200(b). Also like in a civil case,
if the sponsor appears to defend, the Commissioner assumes the role of the court to decide if the
7

Plaintiffs argument that 21 C.F.R. § 514.115(b)(3)(ii) provides for the issuance of an
NOOH only upon a “finding” by BVM, and that such a finding necessarily provides (and indeed
compels) a proposed withdrawal in all circumstances, see Plfs’ Opp. at 5, 10, 15, ignores the fact
that any “findings” by BVM are trumped when the Commissioner decides that they raise
disputed issues of fact that must be resolved at a hearing. See infra pp. 6-7; see also infra at p. 9
(21 C.F.R. § 514.115(b)(3)(ii) (a hearing is required only if an NOOH is currently pending).
8

FDA’s main branches are now referred to as “centers,” but the term “bureau” is used
herein to reflect the terminology used in 1977. See Opening Br. at 5 n.7.
6

NOOH has merit. Initially, the Commissioner decides on “summary judgment”9 whether a
sponsor’s request for a hearing raises an issue of fact. See 21 C.F.R. § 514.200(c); see also
Opening Br. at 14 (citing cases). If the Commissioner discerns an issue of fact, then a “trial” is
set. Id. Plaintiffs’ argument that by issuing the 1977 NOOHs (i.e., a complaint) BVM made a
final determination that could compel withdrawals of the NOOH Products, see Plfs’ Opp. at 6,
turns this entire procedure on its head.10
Plaintiffs are similarly incorrect to argue that, by merely issuing the 1977 NOOHs, BVM
satisfied its “burden of production,” and thereby has shifted the burden of proof on the safety of
the NOOH Products onto the sponsors. Plfs’ Opp. at 7-10. On the contrary, at a withdrawal
hearing, the bureau must first satisfy its burden of production by making out a prima facie case
for withdrawal. See Final Decision of the Commissioner, Withdrawal of Approval of the New
Animal Drug Application for Enrofloxacin in Poultry (“Enrofloxacin Withdrawal”) at 7, Barcelo
Decl. Ex. N. This is similar to a civil plaintiff seeking to survive a motion for judgment as a
matter of law under Rule 50(a) of the Federal Rules of Civil Procedure. Only if the
Commissioner concludes that BVM or CVM has actually carried its initial burden at the hearing
will the burden then shift to the sponsor to defend its drug.11 Enrofloxacin Withdrawal at 7.
Indeed, to further the analogy to civil cases, it is like Plaintiffs are arguing that a civil plaintiff
9

The Supreme Court has referred to this specific procedure as “administrative summary
judgment.” See Weinberger v. Hynson, Wescott and Dunning, Inc., 412 U.S. 609, 617 (1973).

10

The sharp difference between BVM’s decision to issue an NOOH, and the
Commissioner’s subsequent decision on whether the standard under the FDCA for a drug’s
withdrawal has been satisfied, is also highlighted by the strict separation of functions that is
enforced once a hearing is granted. See, e.g., 21 C.F.R. § 10.55(b)(2)(i).
11

Plaintiffs are therefore wrong to argue that the language in the Enrofloxacin Withdrawal
tying the burden that CVM must carry in a hearing on a proposed withdrawal to the language of
section 360b(e)(1), see Plfs’ Opp. at 8 (citing Enrofloxacin Withdrawal at 45), supports their
argument that by issuing an NOOH a bureau has already met that burden.
7

could avoid judgment under Rule 50(a) solely on the ground that it had previously decided to file
a complaint.
Thus, neither the language of the statute, FDAs regulations, nor the mechanics of the
withdrawal process, provide a basis to hold that, by issuing the 1977 NOOHs, BVM has made
the statutory “finding” that could provide a basis for a drug’s withdrawal under section
360b(e)(1).
B.

Statements Made by FDA Officials Outside of the Context of the NOOH
Proceedings Are Irrelevant to the Issues Before the Court
Next, Plaintiffs’ citation to a 1983 Federal Register notice, in which the Commissioner

observed (29 years ago) that the Director of BVM had not changed his position as stated in the
1977 NOOHs, Plfs’ Opp. at 11-13 (citing Penicillin and Tetracycline in Animal Feeds, 48 Fed.
Reg. 4554, 4555-56 (Feb. 1, 1983), Sorenson Decl. Ex. DD), is irrelevant to this case. The
Commissioner did not issue that notice as a decision on the merits following the hearing required
by section 360b(e)(1), but rather to announce FDA’s position that it would hold off on taking
action in light of ongoing research mandated by Congress. See id. at 4555.
Nor is Plaintiffs’ case advanced by the more recent statements by FDA expressing
concerns about the production use of antimicrobials in animals, see Plfs’ Opp. at 13-14, because
those statements also have no bearing on whether FDA’s actions in 1977 could compel the
withdrawal of the NOOH Products now. FDA does have such concerns, and it is implementing a
regulatory strategy to address them. See Opening Br. at 8-10. The drug withdrawal process is
not the only regulatory tool available to FDA. And there is no legal basis for Plaintiffs’ implied
argument that FDA cannot express concerns about drug safety unless it is prepared to proceed
with formal withdrawal proceedings. Such an “all or nothing” approach has no basis in the law
and would hamstring FDA’s ability to advise the public on matters relating to public health.
8

III.

PLAINTIFFS’ CLAIM THAT THE GOVERNMENT IS REQUIRED TO PURSUE
THE 1977 NOOHs EVEN THOUGH IT HAS WITHDRAWN THEM SHOULD BE
DISMISSED AS MOOT
Finally, as the Government argued in its Opening Brief,12 Plaintiffs’ NOOH Claim should

be dismissed because it is moot in light of FDA’s withdrawal of the 1977 NOOHs on December
22, 2011. See Opening Br. at 21-24; citing Barcelo Decl. Ex. L. Because the 1977 NOOHs no
longer exist, there is no basis for further proceedings based on an administrative proposal from
decades ago.
Plaintiffs try to avoid a finding of mootness by arguing that an FDA regulation mandates
that the Agency proceed with a hearing on the withdrawn 1977 NOOHs. See Plfs’ Opp. at 6, 15
(citing 21 C.F.R. § 514.115(b)(3)(ii) (1977)). Plaintiffs are wrong, however, for the regulation
provides that sponsors be given an “opportunity for hearing” prior to a drug’s withdrawal, and
this is needed only when there is an existing “proposal to withdraw approval.” 21 C.F.R.
§ 514.115(b)(3)(ii). There is no longer any such proposal.
Plaintiffs do not raise any other argument apropos to mootness,13 except to say that the
1977 NOOHs should not have been withdrawn in the first instance, and to accuse FDA of
“game” playing. See Pls’ Opp. at 16-22. But Plaintiffs never directly challenge the NOOH

12

Plaintiffs mistakenly argue that the Government did not argue in its Opening Brief that
any claim seeking to compel future withdrawal hearings was moot in light of FDA’s recent
withdrawal of the 1977 NOOHs. Plfs’ Opp. at 16. To the contrary, the Government made
precisely that point. See Opening Br. at 22-23 (arguing that such claim is properly characterized
as a claim of “unreasonable delay” rather than a claim to “compel” agency action, and is moot).
13

The cases cited by Plaintiffs on pages 18 and 19 of their brief have no bearing here. See
id. (citing Public Citizen v. Nuclear Regulatory Comm., 901 F.2d 147 (D.C. Cir. 1990); and
NRDC v. EPA, 595 F. Supp. 1255, 1257 (S.D.N.Y. 1984)). These decisions address agencies’
obligations to promulgate rules that have been specifically required by Congress, and none of
them involved cases seeking to compel agency action pursuant to APA § 706(1).
9

withdrawals,14 and their indignation is surprising in light of their agreement that the 34 year-old
1977 NOOHs were outdated and stale, see Plfs’ Opp. at 20, 22.
Plaintiffs’ remaining arguments have no bearing on the significance of the 1977 NOOHs,
or on the consequences of their withdrawal. Instead, Plaintiffs raise arguments about FDA’s
general approach to the regulation of antibiotics in animal feed. See, e.g, Plfs’ Opp. at 18-19
(positing that the FDCA does not provide for regulatory strategies based in part on voluntary
compliance). These issues, however, all go to whether FDA’s modern regulatory strategy is
lawful, which is the subject of their new Citizen Petitions claim15 that is due to be briefed
beginning later this month. The Government will explain in the upcoming briefing that FDA’s
current approach is reasonable and lawful,16 but this is an issue pertinent to the Citizen Petitions
claim and not to the NOOH Claim. As part of their new Citizen Petitions claim, Plaintiffs will
presumably argue that this Court should compel FDA to issue new withdrawal proposals based
on the scientific understanding of antimicrobial resistance as it exists today. None of this,
however, has any bearing on the simple fact that the long-outdated 1977 NOOHs no longer exist.
CONCLUSION
For the foregoing reasons, the Court should grant summary judgment in favor of the
Government.

14

In making this observation, the Government does not concede that the withdrawals of the
1977 NOOHs would be a legitimate subject for judicial review. Because the issuance of an
NOOH is not a reviewable final agency action, see supra n. 5, its withdrawal is not either.
15

See Plaintiffs’ First Supplemental Complaint for Declaratory and Injunctive Relief. Dkt.

No. 53.
16

As FDA explained in the NOOH Withdrawal, in the 34 years since issuing the 1977
NOOHs, FDA has continued to develop its regulatory strategy with respect the use of antibiotics
in animal feed, and its current strategy is different from the one it proposed in 1977. Barcelo
Decl. Ex. L. FDA’s current strategy involves the potential for withdrawal proceedings in the
future, id. at 79700-01, if FDA determines that such proceedings are warranted.
10

Dated: New York, New York
February 10, 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
Acting 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]

11