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

Filing 81

MEMO ENDORSEMENT on PLAINTIFFS' MOTION TO STRIKE NON-RECORD MATERIAL. ENDORSEMENT: Plaintiffs' motion is granted. So ordered. Granting 79 Motion to Strike Document No. [78-6]. (Signed by Magistrate Judge Theodore H. Katz on 5/2/2012) (rjm)

Case 1:11-cv-03562-THK Document 79

Filed 04/18/11 Page 1 of 4

IN THE UNITED STATES DISTRICT COUJ T
FOR THE SOUTHERN DISTRICT OF NEW y~. ._ _ _"
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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.

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NATURAL RESOURCES DEFENSE)
COUNCIL, INC.; CENTER FOR SCIENCE
IN THE PUBLIC INTEREST; FOOD
ANIMAL CONCERNS TRUST; PUBLIC

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S~ORDERED

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T 'EODORE H. KATZ

UNITED ST~TES MAGISTRATE JUDCi'

I
PLAINTIFFS' MOTION TO STRIKE NON-RECORDIMA TERIAL
Plaintiffs respectfully move to strike an industry statement relier on by FDA in its reply
briefin support of its motion for summary judgment. See Reply Mem'ln Supp. of the
Government's Mot. for Summ. J. on Pis.' First Supplemental Compl.

Jr' Apr. 16,2012 (Dkt.

77). The statement was issued last week by the Animal Health Institutel (AHI), a trade
association representing manufacturers of animal drugs. See Ex. F to Tpird Decl. of Amy A.
Barcelo (3d Barcelo Decl.), Apr. 16,2012 (Dkt. 78-6). It is not part or!he administrative record
that was before FDA when the agency denied plaintiffs' citizen petitiot!ls in November 2011.

Case 1:11-cv-03562-THK Document 79

Filed 04/18/1

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Page 2 of 4

Because this Court's review is limited to the record before FDA at the ti e it denied the
petitions, the Court should strike the AHI statement.

ARGUMENT
I

"It is a widely accepted principle of administrative law that the cburts base their review

of an agency's actions on the materials that were before the agency at th time its decision was
made." IMS, P.e. v. Alvarez, 129 F.3d 618, 623 (D.C. Cir. 1997); see rv; Iter 0. Boswell Mem 'I

Hasp. v. Heckler, 749 F.2d 788, 792 (D.C. Cir. 1984) ("If a court is to r view an agency's action
fairly, it shou Id have before it neither more nor less information than di the agency when it

made its decision." (emphasis added)). Courts do not consider material that postdates the
agency's decision because to do so "risks ... requiring administrators t9 be prescient or allowing
them to take advantage of post hoc rationalizations." Walter 0. Boswell Mem '[ Hasp., 749 F.2d
at 792; see id. at 793-94 (noting that the court had struck the portion of n amicus brief
discussing a study performed after the agency had made its decision).
As a basis for denying plaintiffs' citizen petitions, FDA asserted its faith in the voluntary
cooperation of industry in implementing the agency's Draft Guidance
discourages "injudicious" uses of medically important antibiotics in

N~. 209, which

live~tock.

See FDA, Draft

Guidance No. 209, at 16-17 (2010) (Administrative Record, at FDA 182-83); Ex. A to Decl. of
Mitchell S. Bernard (Bernard Decl.) 4, Feb. 21, 2012 (Dkt. 59-1); Berna d Dec!. Ex. B, at 3-4
(Dkt. 59-2). Having failed to identify any evidence in the record that su ports its professed
confidence in voluntary measures, FDA cannot now rely on AHI's Apri 11,2012 statement,
issued more than five months after the agency denied the petitions. Alth ugh the statement
provides little support for FDA 's

position~it

expresses only vague agreement with FDA's

"direction" on antibiotics in livestock, while maintaining that "there are Idetails that must be
addressed to make this approach practical and workable," see 3d Barcelo Decl. Ex. F, at 1­
2

Case 1:11-cv-03562-THK Document 79

Filed 0411811

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Page 3 of 4

plaintiffs object to FDA's reliance on material that is not part of the ad1inistrative record. This
Court should strike the AHI statement in its entirety.
The same reasoning applies to the three documents that FDA

PU~lished last week and has

submitted twice to this Court-once by letter, dated April 11, 2012, and .• a second time with its

l

reply brief, filed on April 16,2012. See 3d Barcelo Decl. Exs. A, B &

d (Dkts. 78-1 to 78-3).

These documents-Guidance No. 209, Draft Guidance No. 213, and dr1ft proposed revisions to
FDA's Veterinary Feed Directive

regulation-~are

not part of the adminIstrative record on which

FDA denied the citizen petitions. To the extent that FDA now relies on hem to justify its denials
of the petitions, the Court should disregard them.
CONCLUSION

To ensure that it is reviewing FDA's denials of the citizen petitihns based on the same
information that was before the agency when it issued the denials, this
April 11, 2012 statement by AH1 (Dkt. 78-6),
/1
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~ourt should strike the

Case 1: 11-cv-03562-THK Document 79

Dated: April 18,2012

Filed 04/18/12 Page 4 of 4

Respectfully submitted,
Mitchell S. Bernard (MB 5 23)
Natural Resources Defense Counci I, Inc.
40 West 20th Street
New York, New York 100
[phone]
[phone] (fax)
m [e-mail]

sl Jennifer A. Sorenson
i
Avinash Kar, admitted pro ~ac vice
Jennifer A. Sorenson, admitted pro hac vice
Natural Resources Defense Council, Inc.
111 Sutter Street, 20th FloQr
San Francisco, California 9 104
[phone]
[phone] (fax)
[e-mail]; jsorenson nrdc.org
Counsel for Plaintiffs
OfCounsel for Plaintiff Center for Science
in the Public Interest:
Stephen Gardner (SG 3964)
Center for Science in the Publ ic Interest
5646 Milton Street, Suite 211
Dallas, Texas 75206
[phone]
[phone] (fax)
[e-mail]

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