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

Filing 38

MOTION for Leave to File Supplemental Complaint. Document filed by Center For Science In The Public Interest, Food Animal Concerns Trust, Natural Resources Defense Council, Inc., Public Citizen, Inc., Union Of Concerned Scientists, Inc.. (Attachments: # 1 Exhibit A: First Supplemental Complaint)(Bernard, Mitchell)

EXHIBIT A
TO PLAINTIFFS’ MOTION FOR LEAVE TO FILE A SUPPLEMENTAL
COMPLAINT

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF NEW YORK
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Plaintiffs,
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v.
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UNITED STATES FOOD AND DRUG
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ADMINISTRATION; MARGARET
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HAMBURG, in her official capacity as
Commissioner, United States Food and Drug )
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Administration; CENTER FOR
VETERINARY MEDICINE; BERNADETTE )
)
DUNHAM, in her official capacity as
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Director, Center for Veterinary Medicine;
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UNITED STATES DEPARTMENT OF
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HEALTH AND HUMAN SERVICES; and
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KATHLEEN SEBELIUS, in her official
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capacity as Secretary, United States
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Department of Health and Human Services,
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Defendants.
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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.,

11 CIV 3562 (THK)
ECF Case

FIRST SUPPLEMENTAL COMPLAINT FOR DECLARATORY
AND INJUNCTIVE RELIEF
INTRODUCTION
1.

Plaintiffs submit this Supplemental Complaint pursuant to Rule 15(d) of the

Federal Rules of Civil Procedure to challenge the U.S. Food and Drug Administration’s (FDA’s)
denial of two citizen petitions. Plaintiffs incorporate by reference the allegations set forth in their
First Amended Complaint for Declaratory and Injunctive Relief, dated July 7, 2011.

2.

The Federal Food, Drug, and Cosmetic Act (Food and Drug Act), 21 U.S.C.

§ 360b(e)(1), requires FDA to withdraw approval for an animal drug if the agency finds that the
drug is unsafe or not shown to be safe for the uses for which it was approved. In 1999 and 2005,
Plaintiffs Center for Science in the Public Interest (CSPI), Food Animal Concerns Trust (FACT),
Public Citizen, and Union of Concerned Scientists (UCS) submitted citizen petitions (the
Petitions) to FDA requesting that the agency withdraw approvals for nontherapeutic uses of
antibiotics in livestock if those antibiotics are also important to human medicine. The Petitions
asserted that such drug uses present serious human health risks because they promote the
development of antibiotic-resistant bacteria that can be transferred from animals to people.
3.

After delaying ruling on the Petitions for twelve and six years respectively, FDA

denied both Petitions on November 7, 2011, one day before the agency’s response to Plaintiffs’
motion for summary judgment was due in this Court. In its final responses to the Petitions, the
agency acknowledged that it shared the petitioners’ concern about antibiotic resistance related to
antibiotic use in livestock. FDA explained, nevertheless, that rather than withdraw its approval of
nontherapeutic uses of antibiotics in livestock, the agency would address the problem by issuing
a nonbinding draft guidance document, which recommends that livestock producers voluntarily
refrain from using medically important antibiotics for production purposes. FDA defines
“production purposes” as using antibiotics to increase the rate of weight gain or to improve feed
efficiency, rather than to treat any identified disease.
4.

FDA’s final responses to the Petitions are arbitrary, capricious, an abuse of

discretion, or otherwise not in accordance with law, in violation of the Food and Drug Act, 21
U.S.C. § 360b, and the Administrative Procedure Act (APA), 5 U.S.C. § 706(2).

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5.

Plaintiffs Natural Resources Defense Council (NRDC), CSPI, FACT, Public

Citizen, and UCS seek a judgment declaring FDA’s denials of the Petitions unlawful and setting
them aside.
JURISDICTION AND VENUE
6.

This Court has jurisdiction pursuant to 28 U.S.C. § 1331.

7.

Venue is proper in this Court pursuant to 28 U.S.C. § 1391(e)(3), because

Plaintiff NRDC resides and has its principal place of business in this judicial district.
8.

This Court may award Plaintiffs declaratory relief pursuant to the Declaratory

Judgment Act, 28 U.S.C. §§ 2201-02, and may award all necessary injunctive relief for the
claims set forth in the Third Claim for Relief pursuant to the APA, 5 U.S.C. § 706(2).
STATUTORY AND REGULATORY FRAMEWORK
9.

The Secretary of the Department of Health and Human Services, “through the

Commissioner” of FDA, 21 U.S.C. § 393(d)(2), regulates antibiotics in animal feed as “new
animal drugs” under section 512 of the Food and Drug Act, 21 U.S.C. § 360b.
10.

FDA is required to withdraw its existing approval of a new animal drug

application if information shows that the drug is unsafe or not shown to be safe:
The Secretary shall, after due notice and opportunity for hearing to the
applicant, issue an order withdrawing approval of an application . . . if the
Secretary finds . . . that experience or scientific data show that such drug is
unsafe for use under the conditions of use upon the basis of which the
application was approved . . . ; [or] that new evidence not contained in
such application . . . evaluated together with the evidence available to the
Secretary when the application was approved, shows that such drug is not
shown to be safe for use under the conditions of use upon the basis of
which the application was approved . . . .
21 U.S.C. § 360b(e)(1).

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11.

According to FDA’s Guidance for Industry No. 152, FDA considers a new animal

drug “safe” for human health if it concludes that “there is reasonable certainty of no harm to
human health from the proposed use of the drug in food-producing animals.”
THE FACTS
FDA’s Denial of Plaintiffs’ Citizen Petitions
12.

Since the 1950s, FDA has approved some medically important antibiotics for

growth promotion and disease prevention indications in livestock.
13.

On March 9, 1999, CSPI, FACT, Public Citizen, and UCS submitted a petition to

FDA requesting that the agency “rescind approvals for subtherapeutic uses in livestock of any
antibiotic used in (or related to those used in) human medicine.”
14.

On April 7, 2005, FACT and UCS submitted a second petition to FDA. The

petition requested that the FDA Commissioner “withdraw approvals for herdwide/flockwide uses
of [specific] antibiotics in chicken, swine, and beef cattle for purposes of growth promotion
(including weight gain and feed efficiency) and disease prevention and control (except for nonroutine use where a bacterial infection has been diagnosed within a herd or flock).” The petition
covered penicillins, tetracyclines, aminoglycosides, streptogramins, macrolides, lincomycin, and
sulfonamides. It did not cover any uses of those drugs to treat disease in individual animals.
15.

The Petitions asserted that nontherapeutic uses of medically important antibiotics

in livestock present serious risks to human health because they promote the development of
antibiotic-resistant bacteria that can be transferred from animals to people.
16.

The U.S. Department of Health and Human Services has concluded that “there is

a preponderance of evidence that the use of antimicrobials in food-producing animals has
adverse human consequences.” According to the Centers for Disease Control and Prevention,
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there is “strong scientific evidence of a link between antibiotic use in food animals and antibiotic
resistance in humans,” including “multiple North American studies describing how: [u]se of
antibiotics in animals results in resistant bacteria in food animals; [r]esistant bacteria are present
in the food supply and transmitted to humans; [and] [r]esistant bacteria result in adverse human
health consequences (such as increased hospitalizations). . . . [T]here is a compelling body of
evidence to demonstrate this link.”
17.

FDA itself has concluded that “the overall weight of evidence available to date

supports the conclusion that using medically important antimicrobial drugs for production
purposes [in livestock] is not in the interest of protecting and promoting the public health.”
18.

FDA delayed ruling on the Petitions for twelve and six years respectively.

19.

On May 25, 2011, Plaintiffs filed this lawsuit. In their Second Claim for Relief,

Plaintiffs claimed that FDA had delayed unreasonably in issuing a final response to the Petitions.
20.

On November 7, 2011, one day before FDA’s response to Plaintiffs’ motion for

summary judgment was due in this Court, FDA denied both Petitions.
21.

In its final responses to both Petitions, FDA acknowledged that “we share your

concern about the use of medically important antimicrobial drugs in food-producing animals for
growth promotion and feed efficiency indications (i.e., production uses).”
22.

FDA explained that, nevertheless, “for various reasons the Agency has decided

not to institute formal withdrawal proceedings at this time and instead” has “proposed a different
strategy to promote the [voluntary] judicious use of medically important antimicrobials in foodproducing animals” in its Draft Guidance No. 209.
23.

FDA issued Draft Guidance No. 209 in June 2010. The Draft Guidance

recommends that medically important antibiotics be used in food-producing animals only (1)
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when necessary to ensure the animals’ health, and not to promote growth or improve feed
efficiency, and (2) with veterinary oversight. Like other FDA guidance documents, Draft
Guidance No. 209 does “not establish legally enforceable responsibilities.”
24.

Draft Guidance No. 209 has not yet been finalized.

25.

In its final responses to the Petitions, FDA stated, without supporting evidence,

that it “believes that the animal pharmaceutical industry is generally responsive to the prospect of
working cooperatively with the Agency to implement the principles recommended” in Draft
Guidance No. 209. FDA stated that it “intends to work with sponsors who approach FDA and are
interested in working cooperatively with the Agency to phase out production uses of medically
important antimicrobials.”
26.

In denying the Petitions, FDA offered no statutory justification for its refusal to

address the scientific information and analysis presented by the petitioners, to determine whether
the challenged nontherapeutic antibiotic uses in livestock have been shown to be safe for human
health, or to pursue withdrawal proceedings.
Harm to Plaintiffs from FDA’s Denial of the Petitions
27.

The use of antibiotics in livestock promotes the development of antibiotic-

resistant bacteria in animals receiving the antibiotics.
28.

Antibiotic-resistant bacteria are present in the food supply.

29.

Antibiotic-resistant bacteria may be transferred from animals to humans through

the consumption and handling of contaminated meat products, through environmental pathways,
and through direct contact with livestock.

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30.

Antibiotic-resistant bacteria that have been transferred from animals to humans

may cause drug-resistant infections, or they may transfer resistance traits to other bacteria that
can cause infections.
31.

The health of Plaintiffs’ members is continually threatened by their exposure to

meat and poultry products contaminated with bacteria resistant to medically important
antibiotics. As a result, some of Plaintiffs’ members have reduced their meat consumption or
spend more time or money than they otherwise would to buy meat from animals raised without
antibiotics.
32.

The increased risk that Plaintiffs’ members will be exposed to bacteria resistant to

medically important antibiotics through the consumption or handling of contaminated meat
products is traceable to FDA’s failure to withdraw approvals for nontherapeutic uses of
medically important antibiotics in livestock.
33.

If FDA were to grant the Petitions and withdraw approvals for nontherapeutic

uses of medically important antibiotics in livestock, the prevalence of bacteria in livestock with
resistance to those drugs would stop increasing, and would likely decrease. As a result,
Plaintiffs’ members would face a reduced risk of contracting a drug-resistant infection from
consuming or handling meat products.
THIRD CLAIM FOR RELIEF
34.

Plaintiffs incorporate by reference all preceding paragraphs and their First

Amended Complaint for Declaratory and Injunctive Relief.
35.

FDA is required by the Food and Drug Act to withdraw approval for an animal

drug if the agency finds that the drug is unsafe or not shown to be safe for the uses for which it
was approved. See 21 U.S.C. § 360b(e)(1).
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36.

FDA’s stated reasons for denying the Petitions, and for refusing to review the

safety of antibiotics previously approved for nontherapeutic use in livestock, are not grounded in
the Food and Drug Act and contravene the Food and Drug Act.
37.

FDA’s denials of the Petitions contradict the preponderance of scientific

evidence, and FDA’s own prior statements, demonstrating that nontherapeutic uses of medically
important antibiotics in livestock present serious risks to human health.
38.

Because FDA’s reasons for denying the Petitions are not grounded in the Food

and Drug Act and contravene the Food and Drug Act, and because the denials defy sound
scientific evidence that the challenged uses threaten human health, the denials are arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law, in violation of the
Food and Drug Act, 21 U.S.C. § 360b, and the APA, 5 U.S.C. § 706(2).
REQUEST FOR RELIEF
Plaintiffs request that this Court enter judgment against FDA as follows:
A.

Declaring that FDA’s denials of the Petitions are arbitrary, capricious, an abuse of

discretion, or otherwise not in accordance with law, in violation of the Food and Drug Act, 21
U.S.C. § 360b, and the APA, 5 U.S.C. § 706(2);
B.

Setting aside FDA’s denials of the Petitions;

C.

Awarding Plaintiffs their reasonable costs and attorneys’ fees; and

D.

Granting such other and further relief as the Court deems just and proper.

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Dated: New York, New York
January 6, 2012
Respectfully submitted,
s/ Mitchell S. Bernard
Mitchell S. Bernard (MB 5823)
Natural Resources Defense Council, Inc.
40 West 20th Street
New York, New York 10011
[phone]
[phone] (fax)
[e-mail]
Avinash Kar, admitted pro hac vice
Jennifer A. Sorenson, admitted pro hac vice
Natural Resources Defense Council, Inc.
111 Sutter Street, 20th Floor
San Francisco, California 94104
[phone]
[phone] (fax)
Counsel for Plaintiffs
Of Counsel 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)

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