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)(1), and the Administrative Procedure Act ("APA"), 5 U.S.C. § 706(1). The parties have consented to trial before 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.
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
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 In December 2011, the FDA withdrew the original notices on the grounds that they were outdated, and it now argues that Plaintiffs' claim is moot.
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"
The present action pertains to the use of three different antibiotics in animal feed: penicillin and two forms of tetracycline — chlortetracycline and oxytetracycline ("tetracyclines"). Pursuant to the FDCA, any "new animal drug"
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
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 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 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 antibacterial agents used in human medicine." See id.
Over the next two years, the Bureau of Veterinary Medicine ("BVM"),
After carefully considering the recommendations of the NAFDC and the NAFDC sub-committee, the Director of the BVM issued notices of an opportunity
Similarly, the Director of the BVM announced health and safety concerns regarding the subtherapeutic use of tetracyclines in animal feed. The Director explained that "[e]vidence demonstrates that the use of subtherapeutic levels of the tetracyclines ... in animal feed contributes to the increase in antibiotic resistant E. Coli and in the subsequent transfer of this resistance to Salmonella. Further, some strains of E. Coli and Salmonella infect both man and animals.... Thus, the potential for harm exists ...." Tetracycline Notice, 42 Fed.Reg. at 56,267. The Director also noted that, in response to the 1972 FDA regulation announcing the health safety criteria for use of antibiotics in animal feed, the studies submitted by the holders of tetracyclines NADAs/ANADAs "were inconclusive because the studies were inappropriate." Id. The Director concluded that he "is unaware of evidence that satisfies the requirements for demonstrating the safety of extensive use of subtherapeutic tetracycline-containing premixes...." Id. at 56,286. Based on this evidence, the Director proposed to withdraw approval of certain NADAs/ANADAs for the subtherapeutic use of tetracyclines "on the grounds that they have not been show to be safe...." Id.
In response to the 1977 NOOHs, approximately twenty drug firms, agricultural organizations, and individuals requested hearings. See Penicillin and Tetracycline in Animal Feeds Hearing, 43 Fed.Reg. 53,827, 53,826 (Nov. 17, 1978). On November 9, 1978, the Commissioner of the FDA granted the requests for hearings, stating that "there w[ould] be a formal evidentiary public hearing on [the proposed withdrawals]." Id. at 53,827. The Commissioner stated that a date for the hearing would be set "as soon as practicable." Id. at 53,827-28. According to the statutory and regulatory scheme, at the hearing, the drug sponsors would have the burden of proving that the drugs were in fact safe. (See FDA, Final Decision of the Commissioner, Withdrawal of Approval of the New Animal Drug Application for Enrofloxacin in Poultry ("Enrofloxacin Decision"), attached as Ex. N to Barcelo Decl. at 8-9.)
The Commissioner never set a date for the hearings on the BVM's proposal to withdraw approval of the use of penicillin and tetracyclines in animal feed. In the late 1970s and early 1980s, Congressional committees issued three reports that contained statements that the FDA interpreted as requests to postpone the withdrawal hearings pending further research. Specifically, in 1978, the House Committee on Appropriations "recommend[ed]" that the FDA conduct research regarding "whether or not the continued subtherapeutic use of [penicillin and tetracyclines] would result in any significant human health risk" before revoking such approval. H.R. Rep. No. 95-1290, at 99-100 (1978). In 1980, the House Committee on Appropriations requested that the FDA "hold in abeyance any implementation" of the proposed revocation pending further research. H.R. Rep. No. 96-1095, at 105-06 (1980). In 1981, the Senate Committee on Appropriations made a similar request. See S. Rep. No. 97-248, at 79 (1981). Importantly, none of these recommendations was adopted by the full House or Senate, and none was passed as law.
Regardless of the legal effect of these Congressional statements, the FDA never held hearings on the proposed withdrawals, and instead engaged in further research on the risks associated with the subtherapeutic use of antibiotics in foodproducing animals. Soon after the initial House Appropriations Committee request, the FDA contracted with the National Academy of Sciences ("NAS") to assess the human health consequences of the subtherapeutic use of penicillin and tetracyclines in animal feed by evaluating existing data, and to recommend areas for additional research. The NAS issued its report in 1980, drawing no conclusions about the safety of the subtherapeutic use of antibiotics in animal feed and recommending additional epidemiological studies. The FDA then contracted with the Seattle-King County Department of Public Health ("Seattle-King County") and the Institute of Medicine for further research. In 1984, Seattle-King County published its study, finding support for FDA's concerns about the risks posed by antibiotics in animal feeds. For example, the study found that Campylobacter bacteria were likely transferred from chickens to humans through the consumption of poultry products; samples of such bacteria taken from poultry products and humans exhibited "surprisingly high" rates of tetracycline resistance; and drug-resistant Campylobacter could transfer resistant genes to other bacteria. (See Excerpt from Seattle-King County Department of Public Health 1984 Report, attached as Ex. G to Declaration of Jennifer A. Sorenson ("Sorenson Decl.") at 3, 169.) The Institute of Medicine issued its report in 1988. Like the NAS, it could not conclude that the subtherapeutic use of antibiotics in animal feed was safe. However, it found several sources of "indirect evidence implicating subtherapeutic use of antimicrobials in producing resistance in infectious bacteria that causes a potential human health hazard." (See Excerpt from Institute of Medicine 1988 Report, attached as Ex. H to Sorenson Decl. at 194.)
After the publication of the Seattle-King County and the Institute of Medicine studies, the FDA took little action on the still-pending 1977 NOOHs. In 1983, the Commissioner denied requests from several drug sponsors to rescind the 1977 NOOHs. See Penicillin and Tetracycline in Animal Feeds, 48 Fed.Reg. 4,554, 4,556 (Feb. 1, 1983). The Commissioner explained that the 1977 NOOHs "represent[ed] the Director's formal position that use of the drugs is not shown to be safe" and that the Commissioner "concur[red]" with the decision
On June 28, 2010, the FDA released a non-binding Draft Guidance entitled The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals ("2010 Draft Guidance"). (See Guidance No. 209, attached as Ex. B to Barcelo Decl. at 1.) In the Draft Guidance, the FDA reviewed recent scientific studies on the risks posed by the subtherapeutic use of antibiotics in animal feed, including a 1997 World Health Organization expert committee report that "recommended that the use of antimicrobial drugs for growth promotion in animals be terminated if these drugs are also prescribed for use as anti-infective agents in human medicine or if they are known to induce cross-resistance to antimicrobials used for human medical therapy." (See id. at 8.) After reviewing the scientific evidence, the FDA concluded that "the overall weight of evidence available to date supports the conclusion that using medically important antimicrobial drugs for production purposes is not in the interest of protecting and promoting the public health." (Id. at 13.) The FDA announced two non-mandatory principles to guide the use of antibiotics in animal feed: (1) "[t]he use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that are considered necessary for assuring animal health[;]" and (2) "[t]he use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation." (Id. at 16-17.)
On December 16, 2011, nearly twenty-five years after their initial publication and during the pendency of this action, the FDA rescinded the 1977 NOOHs. See Withdrawal of Notices of Opportunity for a Hearing; Penicillin and Tetracycline Used in Animal Feed ("NOOH Withdrawals"), 76 Fed.Reg. 79,697, 79,697 (Dec. 22, 2011). The FDA explained that it was rescinding the NOOHs because the "FDA is engaging in other ongoing regulatory strategies developed since the publication of the 1977 NOOHs" and that if the FDA were to move forward with the NOOHs it would need to "update the NOOHs to reflect current data, information, and policies" and "prioritize any withdrawal proceedings." Id. The FDA noted that "although [it] is withdrawing the 1977 NOOHs, FDA remains concerned about the issue of antimicrobial resistance." Id. at 79,698. The FDA explained that the withdrawal of the NOOHs "should not be interpreted as a sign that FDA no longer has safety concerns or that FDA will not consider reproposing
Plaintiffs filed the present action on May 25, 2011, alleging that the FDA's failure to withdraw approval of the subtherapeutic use of penicillin and tetracyclines pursuant to the 1977 NOOHs constituted an agency action unlawfully withheld or unreasonably delayed in violation of the APA, 5 U.S.C. § 706(1), and the FDCA, 21 U.S.C. § 360b(e)(1).
A motion for summary judgment may not be granted unless the Court determines that there is no genuine issue of material fact to be tried, and that the facts as to which there is no such issue warrant judgment for the moving party as a matter of law. See Celotex Corp. v. Catrett, 477 U.S. 317, 322-23, 106 S.Ct. 2548, 2552-53, 91 L.Ed.2d 265 (1986); Patterson v. Cnty. of Oneida, 375 F.3d 206, 219 (2d Cir.2004); Shannon v. N.Y. City Transit Auth., 332 F.3d 95, 98 (2d Cir.2003). The burden of demonstrating the absence of any genuine dispute as to a material fact rests upon the party seeking summary judgment, see Adickes v. S.H. Kress & Co., 398 U.S. 144, 157, 90 S.Ct. 1598, 1608, 26 L.Ed.2d 142 (1970), but once a properly supported motion for summary judgment has been made, the burden shifts to the nonmoving
Here, the parties do not dispute the essential facts. The only issue before the Court is the legal conclusion resulting from those facts.
"The APA authorizes suit by `[a] person suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of the relevant statute.'" Norton v. S. Utah Wilderness Alliance ("SUWA"), 542 U.S. 55, 61, 124 S.Ct. 2373, 2378, 159 L.Ed.2d 137 (2004) (quoting 5 U.S.C. § 702). Under the APA, an "agency action" includes the "failure to act." 5 U.S.C. § 551(13).
Here, the Director of the BVM, issued the penicillin and tetracyclines NOOHs pursuant to 21 U.S.C. § 360b(e)(1), which governs the withdrawal of approval of NADAs/ANADAs. Specifically, § 360b(e)(1) reads:
21 U.S.C. § 360b(e)(1)(B),
Plaintiffs maintain that § 360b(e)(1) prescribes a set of discrete actions to be taken by the FDA in the event that new evidence shows that a new animal drug has not been shown to be safe. The statute requires that prior to issuing an order withdrawing approval of a NADA/ANADA, the FDA must provide notice to the drug sponsors and an opportunity for a hearing. See 21 U.S.C. § 360b(e)(1). If a drug sponsor or other interested party timely requests a hearing, the FDA must hold a public evidentiary hearing prior to issuing a final withdrawal order.
The FDA has promulgated numerous regulations to guide the withdrawal process. First, the notice issued by the FDA "must contain enough information to provide the respondent a genuine opportunity to identify material issues of fact." Hess & Clark, Div. of Rhodia, Inc. v. Food & Drug Admin. ("Hess & Clark"), 495 F.2d 975, 983 (D.C.Cir.1974); see also Rhone-Poulenc, Inc., Hess & Clark Div. v. Food & Drug Admin. ("Rhone-Poulenc"), 636 F.2d 750, 752 (D.C.Cir.1980); 21 C.F.R. § 514.200(a). If a NADA/ANADA applicant requests a hearing, he must submit, in writing, an explanation of why the NADA/ANADA "should not be withdrawn, together with a well-organized and fullfactual analysis of the clinical and other investigational data he is prepared to prove in support of his opposition to the [proposed withdrawal]." 21 C.F.R. § 514.200(c). If, in his application for a hearing, an applicant fails to raise a genuine and substantial issue of fact, the Commissioner may deny the request for a hearing and summarily withdraw approval for the NADA/ANADA based on the data presented in the original notice. See id.; Hess & Clark, 495 F.2d at 984-85 (approving the FDA's use of the summary judgment procedure where the NOOH presents a "prima facie case for withdrawal"). If a hearing is granted, "the issues will be defined, an Administrative Law Judge will be named, and he shall issue a written notice of the time and place at which the hearing will commence." 21 C.F.R. § 514.200(c). The purpose of the hearing is to provide a "fair determination of relevant facts consistent with the right of all interested persons to participate ...." 21 C.F.R. § 12.87. At the hearing, the FDA has the initial burden of producing evidence that the drug has not been shown to be safe, which is generally contained in the notice. See Rhone-Poulenc, 636 F.2d at 752, (Enrofloxacin Decision at 8.) However, the drug sponsor has the "burden of persuasion on the ultimate question of whether [the drug] is shown to be safe." (Enrofloxacin Decision at 9); see also Rhone-Poulenc, 636 F.2d at 752. As soon as possible after a hearing, the presiding officer issues an initial decision that includes findings of fact, conclusions of law, a discussion of the reasons for the findings and conclusions, and appropriate citations. See 21 C.F.R. § 12.120(a)-(b). A participant in a hearing may appeal an initial decision to
Defendants argue that given the procedural complexity of issuing a notice and holding a hearing, which may take months or years to complete, the relief sought by Plaintiffs is not discrete. The Court disagrees. Upon a finding that a new animal drug has not been shown to be safe, § 360b(e)(1) and the accompanying regulations require the FDA to implement several related discrete actions: (1) provide notice of the FDA's finding and intent to withdraw approval; (2) provide an opportunity for a hearing to the relevant animal drug sponsors; (3) if an applicant timely requests a hearing and raises a genuine issue of fact, hold a hearing; and (4) if the applicant fails to show that the drug is safe, the Commissioner must issue an order withdrawing approval of the drug. The first three steps are statutory precursors to issuing the final withdrawal order. The APA defines "agency action" to include the issuance of an order, see 5 U.S.C. § 551(13), and the Supreme Court has defined an order as a discrete agency action. See SUWA, 542 U.S. at 62, 124 S.Ct. at 2378. Moreover, the APA anticipates that an order will be preceded by a hearing or a similar process, as it defines "adjudication" as the "agency process for formulation of an order[.]" 5 U.S.C. § 551(7); see also 5 U.S.C. § 551(6) (defining "order" as "the whole or part of a final disposition ... of an agency in a matter other than rulemaking but including licensing."). The fact that § 360b(e)(1) requires notice and an opportunity for a hearing prior to the issuance of a withdrawal order does not undermine the fact that the requested relief is a discrete agency action. See id. Plaintiffs are not launching a "broad programmatic attack" on the FDA's animal drug policies; rather, Plaintiffs have identified certain new animal drugs that the agency has publicly concluded are "not shown to be safe" and is requesting that the agency move forward with its statutory duty to hold the requested hearings and withdraw approval if the drug sponsors fail to show that the drugs are safe.
The parties dispute whether, given the facts of this case, § 360b(e)(1) legally requires the Commissioner of the FDA to hold withdrawal proceedings for the relevant penicillin and tetracyclines NADAs/ANADAs. Defendants acknowledge that § 360b(e)(1) contains language mandating the Secretary to act ("[t]he Secretary shall, after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of an application... if the Secretary finds ..."). See Nat'l Ass'n of Home Builders v. Defenders of Wildlife, 551 U.S. 644, 661-62, 127 S.Ct. 2518, 2531-32, 168 L.Ed.2d 467 (2007) (interpreting the statutory language "shall approve" to impose upon the agency a mandatory duty); Lopez v. Davis, 531 U.S. 230, 241, 121 S.Ct. 714, 722, 148 L.Ed.2d 635 (2001) (noting Congress' "use of a mandatory `shall' ... to impose discretionless obligations"); Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26, 35, 118 S.Ct. 956, 962, 140 L.Ed.2d 62 (1998) ("[T]he mandatory `shall' ... normally creates an obligation impervious to judicial discretion."). However, Defendants disagree with Plaintiffs as to when and how the Secretary's duty to act is triggered. Defendants contend that the statute only requires the Secretary to
In interpreting a statute, a court "must give effect to the unambiguously expressed intent of Congress." Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 843, 104 S.Ct. 2778, 2781, 81 L.Ed.2d 694 (1984). "To ascertain Congress's intent, [a court] begin[s] with the statutory text because if its language is unambiguous, no further inquiry is necessary." Cohen v. JP Morgan Chase & Co., 498 F.3d 111, 116 (2d Cir.2007) (citations omitted); see also Tyler v. Douglas, 280 F.3d 116, 122 (2d Cir.2001) ("`If the statutory terms are unambiguous, [a court's] review generally ends and the statute is construed according to the plain meaning of its words.'") (quoting Sullivan v. Cnty. of Suffolk, 174 F.3d 282, 285 (2d Cir.1999)). Statutory interpretation must take into account the "structure and grammar" of the provision. See Bloate v. United States, 559 U.S. 196, ____, 130 S.Ct. 1345, 1354-55, 176 L.Ed.2d 54 (2010). "If the statutory language is ambiguous, however, [a court] will `resort first to cannons of statutory construction, and, if the [statutory] meaning remains ambiguous, to legislative history'" to determine the intent of Congress. Cohen, 498 F.3d at 116 (quoting Daniel v. Am. Bd. of Emergency Med., 428 F.3d 408, 423 (2d Cir.2005)). If the intent of Congress remains unclear, a court will defer to an agency's interpretation of the statute, so long as it is "reasonable." See Chevron, 467 U.S. at 843-44, 104 S.Ct. at 2782.
Here, the statute unambiguously commands the Secretary to withdraw approval of any new animal drug that he finds is not shown to be safe, provided that the sponsor of the animal drug has notice and an opportunity for a hearing. See 21 U.S.C. § 360b(e)(1). The statute does not explicitly state the order in which this process must occur. Defendants maintain that the Secretary can only issue a finding after a hearing, whereas Plaintiffs claim the Secretary makes a finding first, which then triggers the Secretary's obligation to provide notice and an opportunity for a hearing.
The Court finds that Plaintiff's interpretation provides a common sense reading of the statute based on its text and grammatical structure. The statute states that "[t]he Secretary shall, after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of a [] [NADA/ANADA] ... if the Secretary finds ... [that a drug is not shown to be safe] ...." The "after due notice and opportunity for hearing" clause is setoff by commas and immediately precedes the words "issue an order withdrawing approval,"
The text and grammar of other provisions within § 360b support this interpretation. For example, § 360b(d)(1) explicitly requires the Secretary to provide notice and an opportunity for a hearing before making findings regarding the approval or refusal of a NADA. See 21 U.S.C. § 360b(d)(1). Section 360b(d)(1) reads: "If the Secretary finds, after due notice to the applicant ... and giving him an opportunity for a hearing, ... he shall issue an order refusing to approve the application." By placing the "notice" clause immediately after the phrase "[i]f the Secretary finds," § 360b(d)(1) clearly requires notice and an opportunity for a hearing prior to the issuance of findings by the Secretary. The fact that Congress used such language in § 360b(d)(1) and used different language in § 360b(e)(1) supports the Court's conclusion that notice and an opportunity for a hearing are not required before the Secretary makes findings under the latter provision. See Novella v. Westchester Cnty., 661 F.3d 128, 142 (2d Cir.2011) (explaining that the presence of a term in one provision and not in another was deliberate and meaningful).
Moreover, § 360b(e)(1) includes a specific note about the notice and hearing requirement when the Secretary finds that a new animal drug poses an imminent risk to humans or animals, which indicates that findings are made before a hearing. Specifically, the statute states that
21 U.S.C. § 360b(e)(1). This provision anticipates the Secretary making findings in advance of a hearing; otherwise, the clause requiring the Secretary to provide notice and an opportunity for an expedited hearing would be redundant and nonsensical. The Court cannot adopt such an interpretation. See Conn, ex rel. Blumenthal v. Dep't of Interior, 228 F.3d 82, 88 (2d Cir.2000) ("... [courts] are required to `disfavor interpretations of statutes that render language superfluous.'") (quoting Conn. Nat'l Bank v. Germain, 503 U.S. 249,
Accordingly, based on the text and grammar of § 360b(e)(1), as well as the structure of § 360b as a whole and the overriding purpose of the FDA, the Court finds that the plain meaning of § 360b(e)(1) requires the Secretary to issue notice and an opportunity for a hearing whenever he finds that a new animal drug is not shown to be safe. If the drug sponsor does not meet his burden of demonstrating that the drug is safe at the hearing, the Secretary must issue an order withdrawing approval of the drug.
This interpretation is consistent with how courts have interpreted 21 U.S.C. § 355(e), the human drug parallel to § 360b(e). See Food & Drug Admin, v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 134, 120 S.Ct. 1291, 1301, 146 L.Ed.2d 121 (2000) ("If the FDA discovers after approval that a drug is unsafe or ineffective, it `shall, after due notice and opportunity for hearing to the applicant, withdraw approval' of the drug,") (quoting 21 U.S.C. § 355(e)(1)-(3)); Mylan Labs., Inc. v. Thompson, 389 F.3d 1272, 1281 (D.C.Cir.2004) ("[S]ection 355(e) simply sets out specific, not necessarily exclusive, circumstances under which the FDA must withdraw any [human drug] approval (whether final or otherwise) after notice and hearing."); Dobbs v. Wyeth Pharms., 797 F.Supp.2d 1264, 1270-71 (W.D.Okla. 2011) ("The FDA is statutorily responsible for continually monitoring the safety of approved drugs and is authorized to take actions including, inter alia, withdrawal of approval if scientific data indicates the drug is unsafe. 21 U.S.C. § 355(e). Approval must be withdrawn if the FDA finds that ... [a] drug is unsafe for use[.]") (internal quotation marks omitted). Although § 355(e) concerns withdrawal of FDA approval of human drugs, it contains nearly identical language to that in § 360b(e), and, in both the House and Senate Reports on the 1968 Amendments to the FDCA, § 360b(e) was described as "correspond[ing]" to § 355(e). See H.R. Rep. No. 90-875, at 5 (1967); S. Rep. No. 90-1308, at 5 (1968), 1968 U.S.C.C.A.N. 2607, 2611.
Were the Court to conclude that § 360b(e)(1) is ambiguous as to when the Secretary makes findings, the Court would defer to the agency's reasonable interpretation of the statute. See Chevron, 467 U.S. at 842-43, 104 S.Ct. at 2781-82. Although in this litigation the FDA has maintained that findings pursuant to § 360b(e)(1) can only be made after a hearing, the agency's implementing regulation,
Defendants, nevertheless, argue that the regulation does not mean what it says. They claim that the regulation does not refer to the same findings as those in § 360b(e)(1); rather, Defendants assert that the regulation creates a different set of findings that are based on a lower standard than the statutory findings. To support this proposition, Defendants point to several notices of proposed withdrawals that rest on a finding that there is a "reasonable basis from which serious questions about the ultimate safety of [the drug] may be inferred." See Enrofloxacin for Poultry; Opportunity for Hearing ("Enrofloxacin Notice"), 65 Fed.Reg. 64,954, 64,955 (Oct. 31, 2000). Defendants maintain that this "serious question" standard is less stringent than the "not shown to be safe" standard in § 360b(e)(1).
The Court is not persuaded by Defendants' argument. First, although the FDA references the "serious question" standard in several withdrawal notices, the regulatory standard for issuance of any such notice is a finding that the drug is "not shown to be safe." See 21 C.F.R. § 514.115(b)(3)(ii). In fact, the regulation implementing § 360b(e)(1) and authorizing the Commissioner to issue notices describes the requisite findings in exactly the same language as the statute. Compare 21 U.S.C. § 360b(e)(1)(B) ("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
Because the Court reads 21 C.F.R. § 514.115(b)(3) as unambiguously referencing the findings in 21 U.S.C. § 360b(e)(1), the Court cannot defer to Defendants' interpretation that the regulation creates a different set of findings based on a different standard. See Christensen v. Harris Cnty., 529 U.S. 576, 588, 120 S.Ct. 1655, 1663, 146 L.Ed.2d 621 (2000) ("[A]n agency's interpretation of its own regulation is entitled to deference. But [such] deference is warranted only when the language of the regulation is ambiguous.") (internal citations omitted); Gonzales v. Oregon, 546 U.S. 243, 257, 126 S.Ct. 904, 915-16, 163 L.Ed.2d 748 (2006) (refusing to apply deference to an agency's interpretation of its own regulation where the regulation merely "parroted" the statute because "[a]n agency does not acquire special authority to interpret its own words when, instead of using its expertise and experience to formulate a regulation, it has elected merely to paraphrase the statutory language.").
Defendants assert that even if a finding triggers the FDA's obligations pursuant to § 360b(e)(1), there have been no such findings in this case. Defendants maintain that the Director of the BVM, who issued the 1977 NOOHs, is not authorized to make findings pursuant to § 360b(e)(1). The statute does not explicitly authorize the Director to make findings, and Defendants therefore argue that the Court should defer to the agency's position that the Director of the BVM is not authorized to make the requisite findings. See Chevron, 467 U.S. at 842-43, 104 S.Ct. at 2781-82.
As discussed supra, if a court determines that a statute is ambiguous and that "Congress has not directly addressed the precise question at issue," the court must defer to an agency's "reasonable" interpretation of the statute it administers. Id. at 842-44, 104 S.Ct. at 2781-82. "[An] administrative implementation of a particular
Here, § 360b(e)(1) is ambiguous as to whether the Director of the BVM may make the requisite findings. The text of the statute refers to findings made by the "Secretary," which the FDCA defines as the Secretary of HHS. See 21 U.S.C. § 321(d). The Secretary, in turn, delegated to the Commissioner of the FDA all of the authority vested in him pursuant to the FDCA. (See § 1410.10 of Volume III of the FDA Staff Manual Guides, Delegations of Authority to the Commissioner Food and Drugs, attached as Ex. A to Barcelo Decl., ¶ 1(A)(1).) The Commissioner, in turn, delegated authority to the Director of the BVM to issue notices of opportunity for a hearing on proposals to withdraw approval of new animal drug applications, and the authority to issue orders withdrawing approval when the opportunity for a hearing has been waived. (See § 1410.503 of Volume II of the FDA Staff Manual Guides, Issuance of Notice, Proposals, and Orders Relating to New Animal Drugs and Medicated Feed Mill License Applications ("Staff Manual"), attached as Ex. A to Barcelo Decl., ¶ 1(A)(1)-(2).) The question before the Court is whether the authority delegated to the Director includes the authority to make findings that trigger the FDA's non-discretionary duties pursuant to § 360b(e)(1).
Defendants urge the Court to defer to their interpretation that the Director does not have authority to make such findings. Defendants argue that because the Commissioner did not delegate authority to the Director to issue orders of withdrawal after a hearing, the Director cannot make the findings necessary to trigger the FDA's non-discretionary duties under § 360b(e)(1). However, this argument hinges on Defendants' incorrect interpretation of § 360b(e)(1), whereby a finding can be made only after a hearing. As the Court reads § 360b(e)(1) and the accompanying regulations to contemplate findings made prior to a hearing, Defendants' reliance on the Staff Manual is of no avail. In fact, the delegations within the Staff Manual support Plaintiffs' position that the FDA is legally required to re-institute
By authorizing the Director to issue notices of an opportunity for a hearing, the Commissioner necessarily authorized the Director to make the findings on which such notices of withdrawal are based. Any notice issued must "specify the grounds upon which" the proposal to withdraw is based. 21 C.F.R. § 514.200(a). Under both the statute and the regulation, a proposal to withdraw may be based on a finding that an animal drug has not been shown to be safe. See 21 U.S.C. 360b(e)(1)(B); 21 C.F.R. § 514.115(b)(3)(ii). In practice, the Director generally states his conclusion that the drug has not been shown to be safe and cites § 360b(e)(l). See Dimetridazole; Opportunity for Hearing, 51 Fed.Reg. 45,244, 45,244 (Dec. 17, 1986) ("This [notice of intent to withdraw approval] is being [issued] in accordance with section 512(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. § 360b(e)(1)(b)). That section requires FDA to withdraw approval of an NADA if the agency finds ... that such drug is not shown to be safe ... [T]he Center [for Veterinary Medicine] has determined that dimetridazole is not shown to be safe for use within the meaning of section of 512(e)(1)(B)[.]") (emphasis added); Enrofloxacin Notice, 65 Fed.Reg. at 64,954 ("CVM is proposing to withdraw the approval of the new animal drug application for use of enrofloxacin in poultry on the grounds that new evidence shows that the product has not been shown to be safe as provided for in the Federal Food, Drug, and Cosmetic Act ....") (emphasis added). It is clear from the FDA's own practice that the Director of the BVM is authorized to make the requisite findings that trigger withdrawal proceedings pursuant to § 360b(e)(1). Accordingly, by explicitly delegating to the Director the authority to issue withdrawal notices, the Commissioner delegated to the Director the authority to make the findings that are a statutory prerequisite to any such notice.
This conclusion is further supported by the fact that in the event that the Director issues a notice and the drug applicant does not request a hearing, the Director is authorized to summarily issue an order withdrawing approval. (See Staff Manual ¶ 1(A)(2).) In such cases, the findings made by the Director — and upon which the initial notice was based — provide a sufficient basis to withdraw approval of a NADA under § 360b(e)(1). See Shulcon Industries, Inc.; Withdrawal of Approval of a New Animal Drug Application ("Shulcon Withdrawal"), 59 Fed.Reg. 1950, 1950 (Jan. 13, 1994) ("The notice of opportunity for a hearing stated that CVM was proposing to issue an order under [§ 360b(e)] withdrawing approval of the NADA .... Shulcon Industries, Inc. failed to file [a] request for a hearing.... [U]nder authority delegated to the Commissioner of Food and Drugs ... and redelegated to the Center for Veterinary Medicine ... notice is given that approval of NADA 111-068... is hereby withdrawn.").
Although the FDA has been delegated the authority to pass rules and regulations carrying the force of law, the agency has not promulgated any regulation, opinion letter, or internal agency guidance specifying the limits of the Director's delegated authority to which the Court could defer. Moreover, in practice, the Director routinely exercises the authority that the FDA now claims the Director lacks. The Court cannot defer to an interpretation that the FDA appears to have adopted solely for litigation purposes. See Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 212, 109 S.Ct. 468, 473-74, 102 L.Ed.2d 493 (1988) ("[The Supreme Court] h[as] never applied the principle of [Chevron deference]
Having found that the Director of the BVM is authorized to make findings under § 360b(e)(1), the question becomes whether the Director made such findings for the subtherapeutic use of penicillin and tetracyclines. In the 1977 Penicillin Notice, the Director stated that he is
Penicillin Notice, 42 Fed.Reg. at 43,792 (emphasis added). Similarly, in the 1977 Tetracycline Notice, the Director stated that he is
Tetracycline Notice, 42 Fed.Reg. at 56,288. Accordingly, in both the Penicillin and the Tetracycline Notices, the Director explicitly concluded that the drugs had not been shown to be safe and cited § 360b. Such a conclusion is the statutory trigger for the FDA to institute withdrawal proceedings, which it in fact did. Based on the language of the 1977 Notices, the Director made the findings necessary to trigger mandatory withdrawal proceedings for the subtherapeutic uses of penicillin and tetracyclines in animal feed.
Even if the Court were to adopt Defendants' interpretation that the Director is not authorized to make the requisite findings under § 360b(e)(1), the Court would still conclude that the FDA is legally required to hold withdrawal proceedings because the Commissioner has made the requisite findings by noting and ratifying the Director's findings. In 1983, the Commissioner published a statement of policy in the Federal Register denying several requests from drug sponsors to rescind the 1977 NOOHs, in which the Commissioner "concurr[ed]" with the Director's findings that the drugs had not been shown to be safe. See Penicillin and Tetracycline in Animal Feeds, 46 Fed.Reg. at 4,556 (explaining the Director of BVM's decision not to rescind the 1977 NOOHs because
"It has long been settled that a federal court has no authority `to give opinions upon moot questions or abstract propositions, or to declare principles or rules of law which cannot affect the matter in issue in the case before it.'" Church of Scientology of Cal. v. United States, 506 U.S. 9, 12, 113 S.Ct. 447, 449, 121 L.Ed.2d 313 (1992) (quoting Mills v. Green, 159 U.S. 651, 653, 16 S.Ct. 132, 133, 40 L.Ed. 293 (1895)). "The mootness doctrine provides that `an actual controversy must be extant at all stages of review, not merely at the time the complaint is filed.'" Conn. Office of Protection & Advocacy for Persons with Disabilities v. Hartford Bd. of Educ., 464 F.3d 229, 237 (2d Cir.2006) (quoting British Int'l Ins. Co. v. Seguros La Republica, S.A., 354 F.3d 120, 122 (2d Cir.2003)). "The existence of a real case or controversy is an irreducible minimum to the jurisdiction of the federal courts." United States v. City of New York, 972 F.2d 464, 469-70 (2d Cir.1992) (quoting Valley Forge Christian Coll. v. Ams. United for Separation of Church and State, 454 U.S. 464, 471, 102 S.Ct. 752, 757-58, 70 L.Ed.2d 700 (1982)). Accordingly, "if an event occurs while a case is pending ... that makes it impossible for the court to grant any effectual relief whatever to a prevailing party, the [case] must be dismissed." Church of Scientology of Cal., 506 U.S. at 12, 113 S.Ct. at 449 (internal quotation marks and citation omitted).
Here, Defendants maintain that Plaintiffs' claim is now moot because, during the pendency of this case, the FDA rescinded the 1977 NOOHs for the subtherapeutic use of penicillin and tetracyclines in animal feed. See NOOH Withdrawals, 76 Fed. Reg. 79,697, 79,697 (Dec. 22, 2011).
Plaintiffs' claim arises under § 706(1) of the APA, which authorizes the Court to grant Plaintiffs relief if they establish that the FDA failed to take a legally required discrete action. Plaintiffs contend, and the Court agrees, that upon a finding by the FDA that a new animal drug has not been shown to be safe, the FDA is required to withdraw approval of that drug after providing notice and an opportunity for a hearing. Therefore, the trigger for FDA to initiate mandatory withdrawal proceedings is not the issuance of a NOOH but a finding that a drug has not been shown to be safe. The issuance of a NOOH is simply the first step in the mandatory withdrawal process. Accordingly, Plaintiffs are still entitled to relief and their claim is not moot if they can establish that the rescission of the NOOHs did not rescind the FDA's findings that the subtherapeutic use of penicillin and tetracyclines in animal feed has not been shown to be safe.
The record makes clear that the FDA did not rescind its findings when it rescinded the 1977 NOOHs. In the official notice rescinding the 1977 NOOHs, the FDA provided three justifications for the rescission:
NOOH Withdrawals, 76 Fed.Reg. 79,697, 79,698 (Dec. 22, 2011). None of these reasons addresses the initial findings that prompted the NOOHs or suggests that the FDA is rescinding those findings. Rather, in the notice rescinding the 1977 NOOHs, the FDA emphasized its continuing concerns about the subtherapeutic use of penicillin and tetracyclines. "Although FDA is withdrawing the 1977 NOOHs, FDA remains concerned about the issue of antimicrobial resistance. Today's action should not be interpreted as a sign that FDA no longer has safety concerns or that FDA will not consider re-proposing withdrawal proceedings in the future, if necessary." Id. at 79,698. This public announcement of the FDA's continuing safety concerns and its attempts at other strategies support the view that the FDA has not rescinded its original findings that use of the drugs has not been shown to be safe.
In addition, the 2010 Draft Guidance, which represents the FDA's current strategy to address microbial food safety issues, emphasizes the FDA's continuing concerns about the safety of the subtherapeutic use of penicillin and tetracyclines in animal feed. (See Guidance No. 209, attached as Ex. B to Barcelo Decl. at 4.) In preparing the Guidance, the FDA reviewed key scientific studies and reports and concluded that "the overall weight of evidence available to date supports the conclusion that using medically important antimicrobial drugs for production purposes is not in the interest of protecting and promoting the public health." (See id. at 13.)
Lastly, the fact that the FDA "is engaging in other ongoing regulatory strategies," NOOH Withdrawals, 76 Fed. Reg. at 79,698, does not relieve it of its statutory obligation to complete withdrawal proceedings. Upon a finding that the use of a drug under certain conditions has not been shown to be safe, § 360b(e)(1) prescribes a clear course of conduct: issue notice and an opportunity for a hearing, and, if the drug sponsor does not demonstrate that the drug use is safe at the hearing, withdraw approval of such use.
Accordingly, because the rescission of the 1977 NOOHs did not rescind the original findings that the subtherapeutic use of penicillin and tetracyclines in food-producing animals has not been shown to be safe, Plaintiffs' claim is not moot.
For the foregoing reasons, Plaintiffs' Motion for Summary Judgment on their first claim for relief is granted and Defendants' Motion for Summary Judgment is denied. Defendants are hereby ordered to initiate withdrawal proceedings for the relevant NADAs/ANADAs. Specifically, the Commissioner of the FDA or the Director of the CVM must re-issue a notice of the proposed withdrawals (which may be updated) and provide an opportunity for a hearing to the relevant drug sponsors; if drug sponsors timely request hearings and raise a genuine and substantial issue of fact, the FDA must hold a public evidentiary hearing. If, at the hearing, the drug sponsors fail to show that the use of the drugs is safe, the Commissioner must issue a withdrawal order.
The Court notes the limits of this decision. Although the Court is ordering the FDA to complete mandatory withdrawal proceedings for the relevant penicillin and tetracycline NADAs/ANADAs, the Court is not ordering a particular outcome as to the final issuance of a withdrawal order. If the drug sponsors demonstrate that the subtherapeutic use of penicillin and/or tetracyclines is safe, then the Commissioner
So Ordered.
