Natural Resources Defense Council v. United States Food & Drug Administration

884 F. Supp. 2d 108, 2012 WL 3229296, 2012 U.S. Dist. LEXIS 112486
CourtDistrict Court, S.D. New York
DecidedAugust 8, 2012
DocketNo. 11 Civ. 3562(JCF)
StatusPublished
Cited by19 cases

This text of 884 F. Supp. 2d 108 (Natural Resources Defense Council v. United States Food & Drug Administration) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Natural Resources Defense Council v. United States Food & Drug Administration, 884 F. Supp. 2d 108, 2012 WL 3229296, 2012 U.S. Dist. LEXIS 112486 (S.D.N.Y. 2012).

Opinion

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 petitions2 “requesting] that the [112]*112FDA 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-fíled 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 oh 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 [113]*113available.” (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)(l)(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).

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Cite This Page — Counsel Stack

Bluebook (online)
884 F. Supp. 2d 108, 2012 WL 3229296, 2012 U.S. Dist. LEXIS 112486, Counsel Stack Legal Research, https://law.counselstack.com/opinion/natural-resources-defense-council-v-united-states-food-drug-nysd-2012.