Natural Res. Def. Council, Inc. v. U.S. Food & Drug Admin., 11 Civ. 3562(THK).

Decision Date01 June 2012
Docket NumberNo. 11 Civ. 3562(THK).,11 Civ. 3562(THK).
Citation872 F.Supp.2d 318
PartiesNATURAL RESOURCES DEFENSE COUNCIL, INC., et al., Plaintiffs, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Defendants.
CourtU.S. District Court — Southern District of New York

OPINION TEXT STARTS HERE

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, United States Attorney Office, New York, NY, for Defendants.

MEMORANDUM OPINION AND ORDER

THEODORE H. KATZ, United States Magistrate Judge.

On March 22, 2012, this Court granted summary judgment to Plaintiffs Natural Resources Defense Council, Inc. (NRDC), Center for Science in the Public Interest (“CSPI”), Food Animal Concerns Trust (“FACT”), Public Citizen, and Union of Concerned Scientists, Inc. (“UCS”), (collectively Plaintiffs) on their first claim for relief. See Natural Res. Def. Council v. United States Food & Drug Admin., ( “NRDC I” ), No. 11 Civ. 3562(THK), 2012 WL 983544, at *20 (S.D.N.Y. Mar. 22, 2012). The Court determined that Defendants United States Food and Drug Administration (“FDA” or “Agency”), Margaret Hamburg, in her official capacity as Commissioner of the FDA, the Center for Veterinary Medicine (“CVM”), Bernadette Dunham, in her official capacity as Director of the CVM, United States Department of Health and Human Services (“HHS”), and Kathleen Sebelius, in her official capacity as Secretary of HHS, unlawfully withheld agency action by failing to implement withdrawal proceedings pursuant to the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 360b(e), for certain uses of penicillin, oxytetracycline, and chlortetracycline in food-producing animals, See id. Presently before the Court are the parties' cross-motions for summary judgment on Plaintiffs' third claim for relief, which alleges that the FDA acted in violation of the Administrative Procedure Act (“APA”), 5 U.S.C. § 706(2), and the FDCA, 21 U.S.C. § 360b(e), when it denied two Citizen Petitions requesting that the FDA withdraw approval of certain uses of certain classes of antibiotics in food-producing animals. The parties have consented to trial before this Court, pursuant to 28 U.S.C. § 636(c). For the reasons that follow, Plaintiffs' motion is granted and Defendants' motion is denied.

BACKGROUND1

I. Statutory and Regulatory BackgroundA. The Food, Drug, and Cosmetic Act

The FDCA empowers the FDA to regulate drugs sold in interstate commerce, including veterinary drugs. See21 U.S.C. § 393(b). In conjunction with this authority, the FDA is required to “promote the public health” and to ensure that “human and veterinary drugs are safe and effective.” 21 U.S.C. § 393(b)(1)-(2). Specifically, pursuant to the FDCA, the FDA must approve the use or intended use of any “new animal drug” 2 and the labeling thereof. See21 U.S.C. § 360b(a)(1). Any person may submit a new animal drug application (“NADA”) to the FDA for approval of the use or intended use of a new animal drug; the application must include sufficient evidence of the drug's safety and efficacy, including “full reports of investigations which have been made to show whether or not such drug is safe and effective for use [.] 21 U.S.C. § 360b(b)(1)(A).3 In general, the FDA will approve a NADA unless the agency finds that the drug use has not been shown to be safe or effective. See21 U.S.C. § 360b(d)(1); 21 C.F.R. § 514.1(b)(8)(i).

Once the FDA has approved the use of a new animal drug, the applicant holder must make periodic reports to the Agency describing experience with the drug and any new research into the drug's safety and effectiveness. See21 C.F.R. § 514.80(a)(2). The FDA reviews these periodic reports to determine whether approval of the drug use should be suspended or withdrawn pursuant to 21 U.S.C. § 360b(e). See21 C.F.R. § 514.80(a)(3). Section 360b(e)(1) requires the FDA to withdraw approval of a new animal drug if it finds that, based on new evidence, the “drug is not shown to be safe....” See21 U.S.C. § 360b(e)(1)(B).4 The FDA must provide notice of an opportunity for a hearing (“NOOH”) to a drug applicant prior to issuing a withdrawal order. See21 U.S.C. § 360b(e)(1).

B. Regulation of Antibiotics in Food–Producing Animals

In the 1950s, the FDA approved applications for the use of various antibiotics in food-producing animals for a variety of non-disease treatment purposes, including growth promotion, feed efficiency, and disease prevention. For these uses, antibiotics were approved to be administered on a herd- or flock-wide basis at doses lower than those traditionally used to treat disease. When the Agency first approved these uses of antibiotics, little was known about the development of antibiotic-resistant bacteria or the role of agricultural use of antibiotics in the development of resistant bacteria.

However, by the late 1960s scientific evidence had emerged linking the widespread use of antibiotics in food-producing animals at low doses with the development of antibiotic-resistant bacteria. In 1970, the FDA convened a task force to study the risks associated with the use of antibiotics in animal feed. The task force was composed of scientists from the FDA, the National Institutes of Health, the U.S. Department of Agriculture, the Centers for Disease Control, as well as representatives from universities and industry. In 1972, the task force published its findings, concluding that: (1) the use of antibiotics in animal feed, especially at doses lower than those necessary to prevent or treat disease, favors the development of antibiotic-resistant bacteria; (2) animals receiving antibiotics in their feed may serve as a reservoir of antibiotic pathogens, which can produce human infections; (3) the prevalence of bacteria carrying transferrable resistant genes for multiple antibiotics had increased in animals, and the increase was related to the use of antibiotics; (4) antibiotic-resistant bacteria had been found on meat and meat products; and (5) the prevalence of antibiotic resistant bacteria in humans had increased. SeeAntibiotic and Sulfonamide Drugs in Animal Feeds, 37 Fed.Reg. 2,444, 2,444–45 (Feb. 1, 1972). The task force made several recommendations, including that (1) antibiotics used in human medicine be prohibited from use in animal feed unless they met safety criteria established by the FDA, and (2) several specific antibiotics be reserved for therapeutic use unless they met safety criteria for non-therapeutic use. See id. at 2,445.

In response to the findings of the task force, the FDA, in 1973, issued a regulationproviding that the Agency would propose to withdraw approval of all subtherapeutic uses of antibiotics in animal feed unless drug sponsors and other interested parties submitted data within the next two years “which resolve[d] conclusively the issues concerning [the drugs'] safety to man and animals ... under specific criteria” established by the FDA. Antibiotic and Sulfonamide Drugs in the Feed of Animals, 38 Fed.Reg. 9,811, 9,813 (Apr. 20, 1973) (codified at former 21 C.F.R. § 135.109; renumbered at 21 C.F.R. § 558.15). One of the most important of the human and animal health safety criteria that the FDA established for drug safety evaluations involved the transfer of antibiotic resistant bacteria from animals to humans. The FDA required that [a]n antibacterial drug fed at subtherapeutic levels to animals must be shown not to promote increased resistance to antibacterials used in human medicine.” Penicillin–Containing Premixes Notice (“Penicillin Notice”), 42 Fed.Reg. 43,772, 43,774 (Aug. 30, 1977). The other health safety criteria involved showing that use of antibiotics would not increase salmonella in animals, would not increase the pathogenicity of bacteria, and would not increase residues in food ingested by man, which may cause “increased numbers of pathogenic bacteria or an increase in the resistence of pathogens to antibacterial agents used in human medicine.” See id.

Over the next two years, the Bureau of Veterinary Medicine (“BVM”),5 a subdivision of the FDA, reviewed the data submitted by drug sponsors to support the subtherapeutic use of antibiotics. By April 20, 1975, all data concerning the safety and efficacy criteria for antibiotic drugs had been received. See id. at 43,774. The FDA took no immediate action after receiving the data other than, in 1977, issuing notices proposing to withdraw approval of all subtherapeutic uses of penicillin in livestock, seePenicillin Notice, 42 Fed.Reg. at 43, 772, and, with limited exceptions, all subtherapeutic uses of oxytetracycline and chlortetracycline in livestock. SeeTetracycline (Chlortetracycline and Oxytetracycline)-Containing Premises; Opportunity for Hearing (“Tetracycline Notice”), 42 Fed.Reg. 56,264, 56,264 (Oct. 21, 1977). Although the notices were properly promulgated and over twenty drug sponsors requested hearings on the matter, the FDA never held hearings or took any further action on the proposed withdrawals.6

Since 1977, the evidence of the risks to human health posed by antibiotic-resistant bacteria and the link between low-dose antibiotic use and the development of resistant-bacteria has grown. Nevertheless, with limited exceptions, the FDA has not withdrawn approval of the subtherapeutic use of antibiotics in food-producing animals.7 Instead, the FDA has issued several non-binding guidance documents for industry to promote the judicious use of antibiotics.8

II. The Citizen Petitions

The issue presently before the Court involves the FDA's response to two Citizen Petitions, filed in 1999 and 2005, respectively. Both Petitions requested that the FDA begin withdrawal proceedings for all non-therapeutic uses of medically-important antibiotics in food-producing animals.

A. The 1999 Citizen Petition

On March 9, 1999, four of the named Plaintiffs, CSPI, FACT, Public Citizen, and UCS, as well as the...

To continue reading

Request your trial
3 cases
  • Natural Res. Def. Council, Inc. v. U.S. Food & Drug Admin.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (2nd Circuit)
    • 24 Julio 2014
    ...judgment as to the claims that the denial of the citizen petitions was arbitrary and capricious. Natural Res. Def. Council, Inc. v. FDA(“NRDC II ”), 872 F.Supp.2d 318 (S.D.N.Y.2012). According to the district court, the reasons stated in the withdrawal were insufficient to meet even the ver......
  • Natural Res. Def. Council, Inc. v. U.S. Food & Drug Admin., Docket No. 12-2106-cv(L)
    • United States
    • United States Courts of Appeals. United States Court of Appeals (2nd Circuit)
    • 24 Julio 2014
    ...judgment as to the claims that the denial of the citizen petitions was arbitrary and capricious. Natural Res. Def. Council, Inc. v. FDA ("NRDC II"), 872 F. Supp. 2d 318 (S.D.N.Y. 2012). According to the district court, the reasons stated in the withdrawal were insufficient to meet even the ......
  • Natural Res. Def. Council v. U.S. Food & Drug Admin.
    • United States
    • United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
    • 8 Agosto 2012
    ...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......

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT