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

Filing 99

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

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

11 Civ. 3562 (JCF)
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 A STAY PENDING APPEAL

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

TABLE OF CONTENTS

PRELIMINARY STATEMENT .....................................................................................................1
ARGUMENT ...................................................................................................................................1
THE COURT SHOULD GRANT A STAY OF THE ORDER PENDING APPEAL ....................1
A.

The Government Will Present a Substantial Case on the Merits
on Appeal ...................................................................................................1

B.

The Government Will Be Irreparably Injured Absent a Stay ......................6

C.

Issuance of a Stay Will Not Substantially Injure Plaintiffs and
Is in the Public Interest ................................................................................9

CONCLUSION..…………………………………………………………………………………10

TABLE OF AUTHORITIES
CASES
Air Transport Association of Am, Inc. v. National Mediation Board,
663 F.3d 476 (D.C. Cir. 2011) .............................................................................................4
Auer v. Robbins,
519 U.S. 452 (1997) .............................................................................................................4
Barcia v. Sitkin,
2004 WL 691390 (S.D.N.Y. Mar. 31, 2004) .......................................................................9
Encarnacion ex rel. George v. Astrue,
568 F.3d 72 (2d Cir. 2009)...................................................................................................4
FTC v. Standard Oil Co. of California,
449 U.S. 232 (1980) .............................................................................................................7
Gilligan, Will & Co. v. SEC,
267 F.2d 461 (2d Cir. 1959).................................................................................................4
Heckler v. Chaney,
470 U.S. 821 (1985) .............................................................................................................2
Riverkeeper, Inc. v. Collins,
359 F.3d 156 (2d Cir. 2004)............................................................................................. 2-3
Shays v. FEC,
340 F. Supp. 2d 39 (D.D.C. 2004) .......................................................................................7
United States v. Liranzo,
729 F. Supp. 1012 (S.D.N.Y. 1990).....................................................................................3
STATUTES
21 U.S.C. § 360b(e)(1)........................................................................................................... passim
21 U.S.C. § 393(b)(1)-(2) ............................................................................................................2, 6
REGULATIONS
21 C.F.R. § 5.84 (1977) ...................................................................................................................4
21 C.F.R. § 514.115(b)(3)(ii) ...........................................................................................................4

ii

21 C.F.R. § 514.200(c).....................................................................................................................4

iii

PRELIMINARY STATEMENT
The Government has presented substantial—and indeed compelling—arguments that it
will prevail on the merits in its forthcoming appeal. The appeal presents the novel question of
whether proposals made 35 years ago by one FDA1 bureau to withdraw approval for certain uses
of penicillins and tetracyclines in animal feed (i.e., the 1977 NOOHs), divest the Agency of all
discretion on how best to address potential safety issues with those drugs today. The Court’s
ruling that FDA lacks such discretion is both unprecedented and contrary to FDA’s interpretation
of the FDCA.
The Government has also established that it would be irreparably harmed without a stay,
and that a stay would be in the public interest. There is no dispute that withdrawal proceedings
would divert resources from other important programs, and thwart the Agency’s ability to pursue
its priorities in accordance with its best judgment. For a public health agency to be forced to
reallocate resources in a way that it believes will impede its mission constitutes irreparable harm.
ARGUMENT
THE COURT SHOULD GRANT A STAY OF THE ORDER PENDING APPEAL
A. The Government Will Present a Substantial Case on the Merits on Appeal
The Government’s Opening Brief presented strong arguments that Magistrate Judge Katz
erred in interpreting 21 U.S.C. § 360b(e)(1) as requiring FDA to revert to a regulatory strategy
that the Agency has since abandoned in favor of a voluntary compliance strategy. The 1977
NOOHs constituted a preliminary proposal and not a binding Agency “finding” that could be a
basis to compel Agency action then or now, and moreover, FDA has since exercised its
discretion to withdraw the 1977 NOOHs. Opening Br. at 7-14. Plaintiffs do little to rebut the
1

Abbreviations in this brief are the same as in the Government’s opening brief dated June 1,
2012 (the “Opening Br.”).

Government’s arguments for appeal, and their brief mainly reiterates Judge Katz’s March 22 and
June 1 Orders. 2 Plfs’ Br. at 8-15.
The Government has presented substantial arguments that the March 22 Order erred in
interpreting Congress’ intent in enacting 21 U.S.C. § 360b(e)(1), see March 22 Order at 29-54.
Opening Br. at 6-13. For instance, Judge Katz relied in part on a unique application of FDA’s
general mission statement, 21 U.S.C. § 393(b)(1)-(2), but as Plaintiffs effectively concede, such
a “broad statutory mandate” is not enough to compel specific agency action that is not otherwise
required by the statute. Plfs’ Br. at 11; Opening Br. at 9 n.4. More importantly, 21 U.S.C. §
393(b)(1)-(2), does not limit FDA’s discretion in deciding whether to initiate drug withdrawal
proceedings pursuant to 21 U.S.C. § 360b(e)(1), but merely requires that the Agency take
“appropriate” action. The broad language indicates Congress’ intent to vest FDA with
discretion, not detract from it.
Indeed, because of that grant of discretion, the Government will present a substantial case
that, as discussed in Heckler v. Chaney, 470 U.S. 821 (1985), and its progeny, the FDCA grants
broad discretion to FDA in deciding whether to pursue withdrawal proceedings or instead
exercise its discretion to pursue a strategy that the Agency, in its expertise, has determined is the
best way to address a public health issue. Opening Br. at 12-14.3 In this case, the Court should

2

The “June 1 Order” refers to the Court’s order dated June 1, 2012 and entered June 4, 2012
(Dkt. No. 95), granting Plaintiffs’ motion for summary judgment on their claim challenging
FDA’s denials of two citizen petitions.
3

Plaintiffs’ reliance on the purported distinction between the “substantive” and “enforcement”
provisions of the FDCA to argue that FDA’s decision not to pursue withdrawal proceedings was
not an exercise of such discretion, Plfs’ Br. at 14-15 (relying on June 1 Order at 27-34), does not
hold up. Indeed, in Riverkeeper, Inc. v. Collins, 359 F.3d 156 (2d Cir. 2004), the Second Circuit
held that the Chaney presumption against judicial review applies beyond challenges to action
that is “purely enforcement,” and instead applies to any attempt to “convince the [agency] to
enforce the statutes and regulations under its authority . . . in the manner in which [a plaintiff]
thought they should be enforced.” 359 F.3d at 166 n.11. As here, Riverkeeper did not involve
2

be particularly concerned about the effects of its injunction on other FDA programs during the
pendency of the appeal, including those that FDA has deployed as part of its efforts to mitigate
the development of antimicrobial resistance.
Plaintiffs are also wrong that the “rules of grammar” compel only their reading of 21
U.S.C. § 360b(e)(1). Plfs’ Br. at 10. Judge Katz’s decision never explains why the key phrase in
the statute—“after due notice and opportunity for hearing”—cannot refer both to the timing of
the “finding” and to the Commissioner’s order. See March 22 Order at 30. Indeed, the Court
relied on United States v. Liranzo, 729 F. Supp. 1012, 1014 (S.D.N.Y. 1990), in which the key
phrase—“within one thousand feet”—modified multiple words, not just those closest to it. Thus,
the Court’s analysis just as easily supports the Government’s interpretation of section 360b(e)(1).
At a minimum, the statutory language is ambiguous. Plaintiffs do not dispute that
FDA’s interpretation is entitled to Chevron deference in the event of ambiguity. See Opening
Br. at 9. To be clear, FDA’s longstanding interpretation is that the issuance of an NOOH is a
proposal to withdraw a drug, rather than a final decision to withdraw such drug pursuant to
section 360b(e)(1). That is because a final decision can only be reached after the drugs sponsors
have been granted “due notice and opportunity for hearing,” including an opportunity to present

traditional enforcement against alleged wrongdoing, but rather requested changes to the terms of
agency-granted licenses—in that case, for the operation of power plants.
The Court’s June 1 Order was wrong to hold that the Second Circuit’s decision in
Riverkeeper is “irrelevant” to the issue of whether FDA’s determination not to pursue the
Withdrawal Proceedings contemplated by 21 U.S.C. § 360b(e)(1) is subject to judicial review.
June 1 Order at 19. Although the Riverkeeper court noted that because the plaintiffs did not raise
the argument that the agency action at issue was not “enforcement” until their reply brief and
they had waived that argument, the Second Circuit nevertheless stated its “conclusion” that the
agency action at issue was subject to the Chaney presumption against judicial review and
applied, and explained the basis for that conclusion. Riverkeeper, 359 F.3d at 166 n.11. This
same presumption applies here.
3

evidence that might change the ultimate decision.4 Opening Br. at 9-10. Judge Katz incorrectly
merged two separate steps in the course of a drug withdrawal proceeding: the issuance of a
proposal for withdrawal, 21 C.F.R. § 514.115(b)(3)(ii), and the final decision on drug
withdrawal, 21 U.S.C. § 360b(e)(1). March 22 Order at 35. As the context of the two provisions
demonstrates, the regulatory determination to hold hearings is preliminary and initiates a process,
whereas the statutory “finding” concludes the process and encompasses a full record, including
any evidence that might counter the material that informed the notice. Opening Br. at 9-10.
Plaintiffs ignore the FDA regulations that reflect this interpretation. Id. at 9 n.5 (discussing FDA
regulations including 21 C.F.R. § 514.200(c) and 21 C.F.R. § 5.84 (1977)). At the very least, the
Government has a substantial argument that Judge Katz erred in his interpretation, and that
FDA’s interpretation of its regulation is entitled to deference.5 Opening Br. at 10.
Moreover, neither Judge Katz nor Plaintiffs have adequately accounted for the fact that—
even assuming the 1977 NOOHs contain “findings”—FDA has since exercised its discretion to

4

Indeed, due process considerations would argue against any interpretation under which the basis
for the initiation of the NOOH process appears to represent a final agency determination. See
Gilligan, Will & Co. v. SEC, 267 F.2d 461, 468-69 (2d Cir. 1959) (the agency’s “reputation for
objectivity and impartiality is opened to challenge by the adoption of a procedure from which a
disinterested observer may conclude that it has in some measure adjudged the facts as well as the
law of a particular case in advance of hearing it”); Air Transp. Ass’n of Am, Inc. v. Nat’l
Mediation Bd., 663 F.3d 476, 487 (D.C. Cir. 2011) (“[d]ecisionmakers violate the due process
clause and must be disqualified when they act with an ‘unalterably closed mind’ and are
‘unwilling or unable’ to rationally consider arguments”) (quoting Nat’l Advertisers, Inc. v. FTC,
627 F.2d 1151, 1170, 1174 (D.C. Cir. 1979)).
5

Even if deference set forth in Auer v. Robbins, 519 U.S. 452 (1997) were not to apply, FDA’s
interpretation would prevail as persuasive and entitled to Skidmore deference. Cf. Encarnacion
ex rel. George v. Astrue, 568 F.3d 72, 79 (2d Cir. 2009) (declining to determine whether Auer
deference applied, because the agency’s interpretation of its own regulation was entitled to
Skidmore deference).
4

withdraw those determinations.6 Opening Br. at 11-14. As a preliminary matter, Judge Katz’s
conclusion that FDA’s withdrawal was ineffective because the Agency did not separately
withdraw scientific “findings” purportedly made in 1977, March 22 Order at 49-52, overlooked
the fact that, before re-issuing the notices, the Agency would first have to “determine [its]
current scientific positions” regarding the “microbial food safety of the NOOH Products.” (First
Flynn Decl. ¶ 13); see also Opening Br. at 11.
Even more importantly, however, the March 22 Order also did not grant appropriate
scientific and regulatory deference to FDA’s expertise regarding the best approach to the issue of
antimicrobial resistance. Opening Br. at 11-14. Not only is FDA’s determination that the
voluntary compliance strategy is the most effective way to address concerns of antimicrobial
resistance an archetypal exercise of the Agency’s discretion, but in withdrawing the 1977
NOOHs, FDA specifically invoked the same type of discretion that was at issue in Chaney. 7
Opening Br. at 12-14. A 35-year-old preliminary scientific determination and proposal that has
since been withdrawn should not serve as a basis to compel FDA to move forward today with
withdrawal proceedings that it has since determined are not the most effective means to address
the issue of antimicrobial resistance.

6

Because FDA’s withdrawal of the 1977 NOOHs resolved the proceedings the Agency
commenced in 1977 when it issued those notices, Plaintiffs’ claim is also moot. Opening Br. at
14 n.8.
7

The Government will also present strong arguments on appeal that the FDCA and FDA’s
related regulations do not overcome Chaney’s presumption against judicial review by providing
“sufficient guidelines” to curb FDA’s exercise of discretion under 21 U.S.C. § 360b(e)(1). Plfs’
Br. at 15 (citing June 1 Order at 35-38). The regulatory provisions on which the Court relied in
so ruling do not speak to that issue, because they do not instruct FDA regarding the
circumstances in which the Agency must pursue withdrawal proceedings as opposed to pursuing
other regulatory options.
5

B. The Government Will Be Irreparably Injured Absent a Stay
Plaintiffs significantly mischaracterize the Government’s argument that FDA will be
irreparably harmed without a stay. The Government is not, as Plaintiffs argue, alleging
irreparable harm based exclusively on the prospect of wasted expenditure of resources. Plfs’ Br.
at 16. While it is certainly true that the Government might unnecessarily expend a substantial
amount of resources without a stay, see Opening Br. at 14-15, the Government’s argument is
focused on the undisputed fact that resources committed to withdrawal proceedings will be
diverted from other public health programs. This diversion of resources will compromise the
Agency’s ability to pursue its public health goals with respect to antimicrobial resistance and
other important areas. Opening Br. at 15.
As the Government’s cases demonstrate, an agency is irreparably harmed where, as
would be the case here if no stay is granted, its ability to carry out its mission during the
pendency of the appeal would be compromised. Opening Br. at 15-16 (citing cases). Plaintiffs
provide no basis for their proposed distinction of those cases—that the agency action that was
the subject of the injunction in those cases was the same action that the agency claimed was
necessary to fulfill its mission, Plfs’ Br. at 17. Indeed, such a distinction has logic backwards.
That FDA’s authority to pursue its mission through the voluntary compliance strategy is not
subject to challenge in this litigation only serves to strengthen the Government’s arguments that
a stay is warranted.8

8

Although the June 1 Order does not conclude that FDA lacks authority to pursue the voluntary
compliance initiative, it does wrongly state that the initiative is “outside [the FDCA’s] statutory
regulatory scheme.” Plfs’ Br. at 17 (quoting June 1 Order at 52). On the contrary, while 21
U.S.C. § 360b(e)(1) provides one avenue through which FDA may pursue withdrawals of
approvals for certain uses of new animal drugs, the FDCA also authorizes FDA to take all
“appropriate” action to protect the public health, which, includes the voluntary compliance
strategy. See supra pg. 2 (discussing FDA’s authority under 21 U.S.C. § 393(b)(1)-(2)).
6

Plaintiffs’ citation to Shays v. FEC, 340 F. Supp. 2d 39 (D.D.C. 2004), Plfs’ Br. at 16, is
therefore inapposite, because that case does not address whether an agency can be irreparably
harmed by being required to divert resources away from programs that are important to its
mission. Indeed, in Shays, not only did the Federal Election Commission (“FEC”) not make any
claim that its ability to fulfill its mission would be compromised without a stay, but it did not
even claim that any specific programs would be harmed at all. Rather, the FEC made a general
(and unsupported) claim of “diversion of resources from other agency priorities.” 340 F. Supp.
2d at 423. In contrast, FDA has submitted two sworn declarations by William T. Flynn, D.V.M.
M.S., CVM’s Deputy Director for Science Policy (Dkt. Nos. 86, 94), that describe the specific
CVM programs that are central to its public health mission and would be compromised if no stay
is granted: the implementation of FDA’s voluntary compliance strategy (Second Flynn Decl. ¶
9), CVM’s National Antimicrobial Resistance Monitoring System (id.¶ ¶ 10-11), and review of
pending drug applications (id. ¶ 12). Dr. Flynn also explains the reason that these programs will
necessarily be compromised without a stay—the limited number of CVM scientists who are
qualified to work on issues related to antimicrobial resistance (Second Flynn Decl. ¶¶ 8, 11, 12).9
Furthermore, although Plaintiffs prefer their proposed regulatory strategy over FDA’s
current regulatory strategy to address the threat of antimicrobial resistance, Plfs’ Br. at 19, 21-22,
FDA—the agency tasked with regulating animal drug safety—has determined that a voluntary
compliance strategy would yield benefits to public health more quickly and efficiently than
would an immediate resort to drug withdrawal proceedings. See Opening Br. at 16-17. But
unless a stay is granted, FDA expects that it will need to spend 11 to 17 months preparing new

9

FTC v. Standard Oil Co. of California, 449 U.S. 232 (1980), Plfs’ Br. at 16-17, is also not on
point, because the Government does not base its claim of irreparable harm on the litigation
expense that it will incur if the Court does not grant a stay. Standard Oil, 449 U.S. at 232.
7

NOOHs for penicillins and tetracyclines, instead of spending that time working collaboratively
with drug sponsors to transition away from growth promotion uses for all 161 classes of
Medically Important Antimicrobials. It makes sense to let the appeal resolve before FDA’s
preferred regulatory strategy is so radically redirected.
Plaintiffs’ reliance on statements from Judge Katz’s June 1 Order questioning FDA’s
regulatory strategy, Plfs’ Br. at 17, 19, ignores Dr. Flynn’s two declarations (which the June 1
Order does not address). For example, Judge Katz’s speculation that the withdrawal proceedings
may not be resource-intensive because sponsors may not “contest formal withdrawal proceedings
or require time consuming hearings,” Plfs’ Br. at 19 (quoting the June 1 Order at 51), is beside
the point. Before knowing whether sponsors will request hearings, FDA would first need to reissue the 1977 NOOHs which, as Dr. Flynn also explained, would be one of the most resourceintensive parts of the withdrawal proceedings.10 (First Flynn Decl. ¶¶ 8-16.) Indeed, and as Dr.
Flynn also explained, FDA developed its voluntary compliance strategy after determining that it
would be “impracticable to initiate and complete involuntary withdrawal proceedings for the
approximately 161 existing individual approved applications for production uses for Medically
Important Antimicrobials” (Second Flynn Decl. ¶ 5), which conclusion FDA reached after
spending $3.3 million and more than five years to withdraw approval for a single drug, Baytril
(enrofloxacin), through involuntary withdrawal pursuant to 21 U.S.C. § 360b(e)(1). (Second
Flynn Decl. ¶ 4).11

10

Moreover, and as the Government explained in its Opening Brief, by the time the instant
appeal is decided, many (if not all) of the resources needed to prepare the revised NOOHs will
likely have been expended. Opening Br. at 14.
11

Nor does FDA’s determination to pursue a voluntary compliance strategy rather than
involuntary withdrawal proceedings amount to a “conce[ssion of] the absence of an effective
regulatory mechanism.” Plfs’ Br. at 19 (quoting June 1 Order at 45 n.23). FDA has never taken
the position that withdrawal proceedings pursuant to 21 U.S.C. § 360b(e)(1) would not
8

Similarly meritless is Plaintiffs’ argument that FDA’s claim of irreparable harm is
speculative. Plfs’ Br. at 18-19. First, Plaintiffs are wrong that the Government cannot claim
irreparable harm if there is yet no court-ordered “deadline” for the withdrawal proceedings. Plfs’
Br. at 17. As the Government’s Opening Brief and Dr. Flynn’s declarations reflect, the
Government’s arguments are based on FDA’s current projections on the time and resources for
withdrawal proceedings. See Opening Br. at 14. If the Court were to order a more condensed
schedule than that proposed by the Government, it would only magnify the harm.
Plaintiffs’ argument that “there is no reason to believe that withdrawal proceedings will
detract from the agency’s voluntary program to address antibiotic use in livestock production,”
Plfs’ Br. at 19, and that there is no “evidence” that the Government will suffer harm if a stay is
issued, Plfs’ Br. at 17-18, also ignores Dr. Flynn’s two sworn declarations. Those declarations
describe the ways in which FDA’s pursuit of its public health goals with respect to antimicrobial
resistance would be harmed if the Agency is required to move forward with the withdrawal
proceedings. Dr. Flynn’s declarations do not contain “mere[] assert[ions] that burdens will be
imposed” on FDA. Plfs’ Br. at 18 (quoting Barcia v. Sitkin, 2004 WL 691390, *2 n.8 (S.D.N.Y.
Mar. 31, 2004)). As explained above, Dr. Flynn’s declarations describe the basis for that
conclusion as well as the specific CVM programs that would be compromised. See supra pg. 7.
C. Issuance of a Stay Will Not Substantially Injure Plaintiffs and Is in the Public Interest
Finally, the public interest would be served by granting a stay. FDA has determined that
the public health concerns regarding production uses of antibiotics in animal feed would be most
quickly addressed by finalizing and implementing the voluntary compliance initiative described

accomplish FDA’s goals with respect to antimicrobial resistance, but rather has consistently
stated its determination that the Agency’s voluntary compliance strategy is an even more
effective regulatory mechanism. See, e.g., Second Flynn Decl. Ex. C.
9

in Guidance 209 and Draft GFI 213. Opening Br. at 16-17. Plaintiffs’ own views that
withdrawal proceedings are preferable to FDA’s voluntary compliance strategy, Plfs’ Br. at 2022, do not supplant the agency’s determinations. See Opening Br. at 11-12 (citing cases
discussing deference to agencies on matters within their expertise).12
Indeed, and as Plaintiffs do not dispute, the success of the voluntary compliance strategy
would result in the withdrawals of approvals from many more products than would the
withdrawal proceedings. Opening Br. at 19. Moreover, and as Plaintiffs also do not dispute,
were the March 22 Order to be reversed on appeal, it would not be in the public interest to have
wasted public funds and resources in preparation for withdrawal proceedings. Id.
CONCLUSION
For the foregoing reasons, the Court should grant the Government’s motion for a stay of
the March 22 Order pending appeal. If the Court denies the Government’s motion for a stay
pending appeal, the Government respectfully requests an interim stay of the Order pending
disposition of a possible motion for a stay in the United States Court of Appeals for the Second
Circuit.

12

Plaintiffs inaccurately describe FDA’s voluntary compliance strategy. Plfs’ Br. at 21 (citing
FDA’s denials of two citizen petitions filed by certain of the Plaintiffs). In April of this year,
through Draft GFI 213, FDA stated its intention to request that sponsors of Medically Important
Antimicrobials notify the Agency within three months of the date that Draft GFI 213 is finalized
regarding whether they intend to participate in that voluntary strategy. See Second Flynn Decl.
Ex. C at 7. As FDA stated in Draft GFI 123, the Agency then anticipates that the sponsors of the
affected products should be able to complete implementation of the changes discussed in this
draft guidance within three years from the date that guidance is finalized. Id.
10

Dated:

New York, New York
June 18, 2012
Respectfully submitted,
PREET BHARARA
United States Attorney for the
Southern District of New York
Attorney for Defendants

By:

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

OF COUNSEL:
DAVID J. HOROWITZ
Deputy General Counsel

ELIZABETH H. DICKINSON
Chief Counsel, Food and Drug
Division

ERIC M. BLUMBERG
Deputy Chief Counsel, Litigation

THOMAS J. COSGROVE
Associate Chief Counsel

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

11