Natural Res. Def. Council v. U.S. Food & Drug Admin.

Citation884 F.Supp.2d 108
Decision Date08 August 2012
Docket NumberNo. 11 Civ. 3562(JCF).,11 Civ. 3562(JCF).
PartiesNATURAL RESOURCES DEFENSE COUNCIL, Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen, Inc., and Union of Concerned Scientists, Inc., 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 Sibelius, in her official capacity as Secretary, United States Department of Health and Human Services, Defendants.
CourtU.S. District Court — Southern District of New York

884 F.Supp.2d 108

NATURAL RESOURCES DEFENSE COUNCIL, Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen, Inc., and Union of Concerned Scientists, Inc., 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 Sibelius, in her official capacity as Secretary, United States Department of Health and Human Services, Defendants.

No. 11 Civ. 3562(JCF).

United States District Court,
S.D. New York.

Aug. 8, 2012.


[884 F.Supp.2d 111]


Mitchell S. Bernard, Natural Resources Defense Council, Inc., New York, NY, Avinash Kar, Jennifer Ann Sorenson, Natural Resources Defence Council, Inc., San Francisco, CA, for Plaintiffs.

Amy Ann Barcelo, Ellen Melissa London, U.S. Attorney Office, New York, NY, for Defendants.


MEMORANDUM AND ORDER

JAMES C. FRANCIS IV, United States Magistrate Judge.

Plaintiffs Natural Resources Defense Council, Inc. (“NRDC”), Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen, and Union of Concerned Scientists brought this action against the various government defendants seeking to compel the United States Food and Drug Administration (the “FDA”) to initiate proceedings to withdraw its approval of the use of certain antibiotics in livestock for non-therapeutic purposes. 1 ( Memorandum Opinion and Order dated March 22, 2012, 884 F.Supp.2d 127, 130–31 (S.D.N.Y.2012) (“ March 22 Order”)). The parties consented to the jurisdiction of a magistrate judge, and on March 22, 2012, the Honorable Theodore H. Katz, U.S.M.J., granted the plaintiffs' motion for summary judgment and denied the defendants' motion for summary judgment on the plaintiffs' first claim for relief, which charged the defendants with violating the Administrative Procedure Act (the “APA”), 5 U.S.C. § 706(2), and the Food, Drug, and Cosmetic Act (the “FDCA”), 21 U.S.C. § 360b(e), for failing to implement such proceedings. ( March 22 Order at 130, 151). On June 1, 2012, Judge Katz issued an opinion granting the plaintiffs' motion for summary judgment and denying the defendants' motion for summary judgment on the plaintiffs' third claim for relief, which alleged that the FDA violated the same two statutes when it denied two citizen petitions 2 “request[ing] that the

[884 F.Supp.2d 112]

FDA begin withdrawal proceedings for all non-therapeutic uses of medically-important antibiotics in food-producing animals.” ( Memorandum Opinion and Order dated June 1, 2012 (“June 1 Order”), 872 F.Supp.2d 318, 324 (S.D.N.Y.2012)).

The March 22 Order requested additional briefing on the issue of a schedule under which the FDA must act. (March 22 Order at 152 n. 19). In the midst of that briefing, the Government appealed the March 22 Order (Notice of Appeal dated May 21, 2012) and filed a motion requesting that this Court stay the March 22 Order pending resolution of the appeal or, in the alternative, impose an interim stay pending disposition of the Government's not-yet-filed stay application in the United States Court of Appeals for the Second Circuit (Memorandum of Law in Support of the Government's Motion for a Stay Pending Appeal (“Gov't Stay Memo.”) at 1). The plaintiffs, for their part, filed a motion to strike documents that the Government submitted in connection with its motion for summary judgment on the third claim for relief. (Plaintiffs' Motion to Strike Non–Record Material (“Motion to Strike”)).

Upon Judge Katz' retirement, this case was reassigned to me. Before me now, then, are the parties' briefs regarding timing, the Government's motion for a stay, and the plaintiffs' motion to strike, and I held oral argument on these issues on July 18, 2012. For the reasons that follow, the plaintiffs' motion to strike is granted in part; the Government's proposed schedule for compliance with the March 22 Order is adopted; and the Government's motion for a stay is denied.

Background

The facts of the case are set out in the March 22 and June 1 Orders, with which I assume familiarity. Nevertheless, some background will be helpful in understanding the following discussion.

In the 1950s, the FDA approved the use of antibiotics “to stimulate growth and promote feed efficiency in food-producing animals” and issued permissions (by approving new animal drug applications or abbreviated new animal drug applications) for penicillin and tetracyclines to be used for such purposes. (March 22 Order at 131–32). By the mid–1970s, however, the FDA, concerned with the public health risk to humans and animals of antibiotic resistance caused by such uses, issued a regulation “providing that the agency would propose to withdraw approval of all [non-therapeutic] uses of antibiotics in animal feed unless drug sponsors and other interested parties” presented data resolving the agency's concerns. (March 22 Order at 132–33). Thereafter, the FDA's Bureau of Veterinary Medicine (the “BVM”) (which has since been renamed the Center for Veterinary Medicine (the “CVM”)), along with a subcommittee of the FDA's National Advisory Food and Drug Committee (the “NAFDC”) reviewed the data submitted. (March 22 Order at 133 & n. 5). In 1977, the NAFDC adopted the report and recommendations of its subcommittee, which advised the FDA to “withdraw approval for the [non-therapeutic] uses of penicillin” and “discontinue the[ ] use [of tetracyclines] for growth promotion and/or feed efficiency in all animal species for which effective substitutes are

[884 F.Supp.2d 113]

available.” (March 22 Order at 133–34 (internal quotation marks omitted)).

Later in 1977, after review of the NAFDC recommendations, the Director of the BVM issued notices of an opportunity for hearing (“NOOHs”) on proposals to withdraw approval of all non-therapeutic uses of penicillin in animal feed and most non-therapeutic uses of tetracyclines in animal feed. (March 22 Order at 133–34). The FDA issued the NOOHs pursuant to a subsection of the provision of the FDCA governing “New Animal Drugs”:

The Secretary [of the Department of Health and Human Services] shall, after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of an application ... with respect to any new animal drug if the Secretary finds ... that new evidence not contained in such application or not available to the Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, 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)(B). In response, “approximately twenty drug firms, agricultural organizations, and individuals requested hearings,” at which, pursuant to the statutory and regulatory scheme, they would have the burden of proving that the relevant uses of the drugs were safe. (March 22 Order at 134).


The Commissioner of the FDA granted the hearing requests, but no hearings were ever scheduled. (March 22 Order at 134–35). Instead, the FDA continued to research the risks connected with the non-therapeutic uses of antibiotics in the feed of food-producing animals, contracting with various agencies to study the problem. (March 22 Order at 135–36). Three reports released in the 1980s—by the National Academy of Sciences, the Seattle–King County Department of Public Health, and the Institute of Medicine-were unable to conclude that the non-therapeutic use of antibiotics in animal feed was safe, instead finding support for the FDA's concerns. (March 22 Order at 135–36).

In June 2010, the FDA released a non-binding Draft Guidance, which reviewed recent studies on the risks of non-therapeutic uses of antibiotics in animal feed and concluded that the evidence supported the conclusion “that using medically important [antibiotic] drugs for production purposes is not in the interest of protecting and promoting the public health.” (March 22 Order at 136 (internal quotation marks omitted)). The FDA recommended restricting the use of antibiotics in food-producing animals to uses necessary for ensuring medical health and uses including veterinary oversight or consultation. (March 22 Order at 136).

The plaintiffs filed this action in May 2011 “alleging that the FDA's failure to withdraw approval of the [non-therapeutic] use of penicillin and tetracyclines pursuant to the 1977 NOOHs constituted an agency action unlawfully withheld or unreasonably delayed in violation” of the APA and the FDCA. (March 22 Order at 137). In December 2011, the FDA rescinded the 1977 NOOHs, explaining that it continued to be concerned about antibiotic resistance, but that it was “engaging in other regulatory strategies ... and that if [it] were to move forward with the NOOHs it would need to update [them] to reflect current data, information, and policies and prioritize any withdrawal proceedings.”

[884 F.Supp.2d 114]

(March 22 Order at 136 (internal quotation marks omitted)). In February 2012, the plaintiffs filed a supplemental complaint against the defendants contending that the FDA had violated the APA and the FDCA when it denied two citizen petitions submitted by certain plaintiffs and non-parties (one in 1995 by Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen, Union of Concerned Scientists, and non-party Environmental Defense Fund; one in 2005 by Union of Concerned Scientists and non-parties Environmental Defense Fund, American Academy of Pediatrics, and American Public Health Association). (June 1 Order at 321, 324, 326).

In the March 22 Order, Judge Katz held, first,...

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