Natural Res. Def. Council, Inc. v. United States Food & Drug Admin.

• Decision Date: 22 March 2012
• Docket Number: 11 Civ. 3562(THK)
• Parties: NATURAL RESOURCES DEFENSE COUNCIL, INC., et al., Plaintiffs, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Defendants.
• Court: U.S. District Court — Southern District of New York

NATURAL RESOURCES DEFENSE COUNCIL, INC., et al., Plaintiffs,

v.UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Defendants.

11 Civ. 3562(THK)

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK

DATED: March 22, 2012

MEMORANDUM OPINION AND ORDER

THEODORE H. KATZ, 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, Inc. (collectively "Plaintiffs") bring this action against the United States Food and Drug Administration ("FDA"), 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, alleging that the FDA withheld agency action in violation of the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 360b(e)(l), and the Administrative Procedure Act ("APA"), 5 U.S.C. § 706(1). The parties have consented to trialbefore this Court, pursuant to 28 U.S.C. § 636(c). Presently before the Court are the parties' cross-motions for summary judgment. For the reasons that follow, Plaintiffs motion is granted and Defendants' motion is denied.

BACKGROUND¹

I. Overview

For over thirty years, the FDA has taken the position that the widespread use of certain antibiotics in livestock for purposes other than disease treatment poses a threat to human health. In 1977, the FDA issued notices announcing its intent to withdraw approval of the use of certain antibiotics in livestock for the purposes of growth promotion and feed efficiency, which the agency had found had not been proven to be safe. The FDA issued the notices pursuant to 21 U.S.C. § 360b(e) (1), which states that

[t]he Secretary 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 . . . (fi) 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 1 when such application was approved, evaluated together with the evidence available to the Secretary when the applicationwas 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). 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.

In the intervening years, the scientific evidence of the risks to human health from the widespread use of antibiotics in livestock has grown, and there is no evidence that the FDA has changed its position that such uses are not shown to be safe. In May 2011, after the FDA failed to respond to two Citizen Petitions urging the agency to follow through with the 1977 notices, Plaintiffs filed this action seeking a court order compelling the FDA to complete the withdrawal proceedings for antibiotics included in the 1977 notices. In December 2011, the FDA withdrew the original notices on the grounds that they were outdated, and its now argues that Plaintiffs' claim is moot.

II. Use of Antibiotics in Food-Producing Animals

Antibiotics, also known as antimicrobials, are drugs used to treat infections caused by bacteria. Although antibiotics have saved countless lives, the improper use and overuse of antibiotics has led to a phenomenon known as antibiotic resistance.Specifically, the misuse of antibiotics creates selective evolutionary pressure that enables antibiotic resistant bacteria to increase in numbers more rapidly than antibiotic susceptible bacteria, increasing the opportunity for individuals to become infected by resistant bacteria. People who contract antibiotic-resistant bacterial infections are more likely to have longer hospital stays, may be treated with less effective and more toxic drugs, and may be more likely to die as a result of the infection. The FDA considers antibiotic resistance "a mounting public health problem of global significance." (First Amended Complaint ("First Am. Compl.") ¶ 38; Answer ¶ 38.)

In the 1950s, the FDA approved the use of antibiotics to stimulate growth and improve feed efficiency in food-producing animals, such as cattle, swine, and chickens. Antibiotics used for growth promotion are typically administered through animal feed or water on a herd- or flock-wide basis. The approved doses of antibiotics for growth promotion are typically lower than the approved doses for disease treatment. The administration of "medically important"² antibiotics to entire herds or flocks offood-producing animals, at "subtherapeutic"³ levels, poses a qualitatively higher risk to public health than the administration of such drugs to individual animals or targeted groups of animals to prevent or treat specific diseases. (See Answer ¶ 34.) Research has shown that the use of antibiotics in livestock leads to the development of antibiotic-resistant bacteria that can be — and has been — transferred from animals to humans through direct contact, environmental exposure, and the consumption and handling of contaminated meat and poultry products. Consequently, the FDA 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." (Guidance No. 2 09, attached as Exhibit B ("Ex. B") to Declaration of Assistant United States Attorney Amy A. Barcelo ("Barcelo Decl.") at 13.)

III. Penicillin in and Tetracyclines

The present action pertains to the use of three differentantibiotics in animal feed: penicillin and two forms of tetracycline - chlortetracycline and oxytetracycline ("tetracyclines"). Pursuant to the FDCA, any "new animal drug"⁴ that is introduced into interstate commerce must be the subject of an FDA approved new animal drug application ("NADA") or, with respect to generic drugs, an abbreviated NADA ("ANADA"). See 21 U.S.C. § 360b(b)-(c). Drug companies that submit NADAs/ANADAs are typically referred to as "applicants" or "sponsors." The FDA lawfully issued NADAs and ANADAs for penicillin and tetracyclines in the mid-1950s. Since that time, penicillin has been used to promote growth in chickens, turkeys, and swine, and tetracyclines have been used to promote growth in chickens, turkey, swine, cattlel, and sheep.

In the mid-1960s, the FDA became concerned that the long-term use of antibiotics, including penicillin and tetracyclines, in food-producing animals might pose threats to human and animal health. As a result, in 1970, the agency 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 Center 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. See Antibiotic 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 drugs, including penicillin and tetracyclines, 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 regulation providing that the agency would propose to withdraw approval of all subtherapeutic uses of antibiotics inanimal 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 under the regulation involved the transfer of antibiotic resistant bacteria from animals to humans. The FDA regulation 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...