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

Filing 80

MEMO ENDORSEMENT on PLAINTIFFS' MOTION TO COMPLETE THE ADMINISTRATIVE RECORD. ENDORSEMENT: Plaintiff's motion is granted. So ordered. Granting 76 Motion to Complete the Administrative Record re: 66 Notice (Other), Notice (Other). (Signed by Magistrate Judge Theodore H. Katz on 5/2/2012) (rjm)

Case 1:11-cv-03562-THK Document 76

Filed 04102112 Page 1 of 4

IN THE UNITED STATES DISTRICT COURT

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FOR THE SOUTHERN DISTRICT OF NffF.,~i~q~7:::::::;----·-NATURAL RESOURCES DEFENSE)
COUNCIL, INC.; CENTER FOR SCIENCE
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IN THE PUBLIC INTEREST; FOOD
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ANIMA,L CONCERNS TRUST; PUBLIC)
CITIZEN, INC.; and UNION OF
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CONCERNED SCIENTISTS, INC.,
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Plaintiffs.
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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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SO ORDERED I

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THEODORE H. KATZ
UNITED STATES MAGISTRATE JUDGE

documents that were before the U.S. Food and Drug Administration (FDA) when it denied
plaintiffs' citizen petitions. The three documents are industry comments on FDA's Draft
Guidance No. 209, which discourages "injudicious" uses of medically important antibiotics in
livestock. See FDA, Draft Guidance No. 209, at 16-17 (2010) (Administrative Record, at FDA
182-83); Exs. C, D & E to Decl. of Mitchell S. Bernard (Bernard Decl.), Feb. 21, 2012 (Dkts. 59­

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Plaintiffs respectfully move for an order completing the administrative record with three

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PLAINTIFFS'MOTION TO COMPLETE THE ADMINISTRATIVE RECORD

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Case 1:11-cv-03562-THK Document 76

Filed 04102/12 Page 2 of4

As a basis for denying plaintiffs' citizen petitions, FDA asserted its faith in the voluntary
cooperation of industry in implementing Draft Guidance No. 209. The industry comments bear
directly on plaintiffs' legal claims and are properly part of the administrative record under the
Administrative Procedure Act's "whole record" review standard. 5 U.S.C. § 706.

ARGUMENT
In determining whether the petition denials were "arbitrary, capricious, ... or otherwise
not in accordance with law," this Court must "review the whole record or those parts of it cited
by a party." 5 U.S.c. § 706; see Dopico v. Goldschmidt, 687 F.2d 644, 654 (2d Cir. 1982);

Walter 0. Boswell Mem 'I Hosp. v. Heckler, 749 F.2d 788, 792 (D.C. Cir. 1984). The "'complete
administrative record consists of all documents and materials directly or indirectly considered by
the agency.'" Merritt Parkway Conservancy v. Mineta, 424 F. Supp. 2d 396, 403 (D. Conn.
2006) (quoting Bar MK Ranches v. Yuetter, 994 F.2d 735, 739 (lOth Cir. 1993») (emphasis
added); see Dopico, 687 F.2d at 654 (holding that the administrative record encompasses the
agency's "informational base" at time of the disputed decision); Walter 0. Boswell Mem '/ Hosp.,
749 F.2d at 792 (holding that a reviewing court "should have before it neither more nor less
information than did the agency when it made its decision"). Courts "must protect the public
interest in ensuring that agencies do not ignore inconvenient information or skew the
record ... by excluding pertinent but unfavorable information." Merritt Parkway, 424 F. Supp.
2d at 403 (internal quotation marks omitted).
The three industry comments filed as Exhibits C, 0, and E to the Bernard Declaration fall
well within the scope of FDA's adm inistrative record for the petition denials. The comments
were submitted to FDA in August 2010, in response to the agency's request for comments on
Draft Guidance No. 209. They are signed by the Animal Health Institute, the national trade

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Case 1: 11-cv-03562-TH K Document 76

Filed 04/02/12 Page 3 of 4

association representing manufacturers of animal drugs; Alpharma, an animal drug
manufacturer; and the American Farm Bureau Federation. FDA posted the comments to its
public docket for Draft Guidance No. 209 at www.regulations.gov.
In denying the petitions in November 2011, FDA proposed to address the problem of
antibiotic resistance by "work[ing] with [drug] sponsors who approach FDA and are interested in
working cooperatively" "to implement the principles recommended in draft [Guidance] #209."

See Bernard Dec!. Ex. A, at 4 (Dkt. 59-1). The agency asserted that "[b]ased on feedback this
Agency has received following the issuance of draft [Guidance] #209, FDA believes that the
animal pharmaceutical industry is generally responsive to working cooperatively with the
Agency." Id. The Government included Draft Guidance No. 209 in the administrative record it
filed with this Court, but it omitted the industry comments. See Administrative Record, at FDA
167-85. The comments question whether the use of antibiotics to promote animal production
poses any threat at all to human health. See Bernard Decl. Ex. C, at 1-2; id. Ex. D, at 1-2; id. Ex.
E, at 3. Plaintiffs have argued that, even if FDA's reliance on voluntary measures were a
legitimate statutory basis for denying the petitions, the agency has offered no evidence to support
its professed confidence in the efficacy of voluntary measures, and in fact there is no reason to
believe that such measures will be effective. The industry comments on Draft Guidance No. 209
are probative ofthe question whether the evidence that was before the agency supports FDA's
stated rationale for denying the petitions.

CONCLUSION
To ensure that it can review the petition denials on the "whole record," 5 U.S.c. § 706,
this Court should grant plaintiffs' motion and order the administrative record completed with the
documents filed as Exhibits C, D, and E to the Bernard Declaration.

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Case 1:11-cv-03562-THK Document 76

Dated: April 2, 2012

Filed 04/02/12 Page 4 of 4

Respectfully submitted,

Mitchell S. Bernard (MB 5823)

Natural Resources Defense Council, Inc.

40 West 20th Street

New York, New York 10011

[phone]
[phone] (fax)
[e-mail]

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

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