Kripke v. United States Food And Drug Administration et al

MOTION to Dismiss for Failure to State a Claim and for Standing

S.D. Cal.September 26, 2016

Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 BENJAMIN C. MIZER Principal Deputy Assistant Attorney General JONATHAN F. OLIN Deputy Assistant Attorney General Civil Division U.S. Department of Justice MICHAEL S. BLUME, Director MONICA GROAT, Trial Attorney Virginia Bar No. 80421 Consumer Protection Branch U.S. Department of Justice P.O. Box 386 Washington, D.C. 20044 (202) 532-4218 (phone) (202) 514-8742 (fax) Monica.C.Groat@usdoj.gov Attorney for Defendants UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF CALIFORNIA DANIEL KRIPKE, on behalf of ) himself and the general public, ) ) Plaintiff, ) ) v. ) Case No: 3:16-cv-1214-H-BLM ) UNITED STATES FOOD AND ) Motion to Dismiss DRUG ADMINISTRATION; ) ROBERT M. CALIFF, ) Judge: The Honorable Marilyn L. in his official capacity as ) Huff Commissioner, United States Food ) Location: Courtroom 15A and Drug Administration; UNITED ) STATES CENTER FOR DRUG ) EVALUATION AND RESEARCH; ) JANET WOODCOCK, in her official ) capacity as Director, United States ) Center for Drug Evaluation and ) Case 3:16-cv-01214-H-BLM Document 6 Filed 09/26/16 Page 1 of 4 2 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Research; UNITED STATES ) DEPARTMENT OF HEALTH AND ) HUMAN SERVICES; and SYLVIA ) MATTHEWS BURWELL, in her ) official capacity as Secretary, United ) States Department of Health and ) Human Services, ) ) Defendants. ) _______________________________) Defendants the United States Food and Drug Administration; Robert M. Califf, M.D.; FDA’s Center for Drug Evaluation and Research; Janet Woodcock; the United States Department of Health and Human Services; and Sylvia Matthews Burwell moves to dismiss Plaintiff’s Complaint, pursuant to Federal Rule of Civil Procedure 12(b)(1) and 12(b)(6). Case 3:16-cv-01214-H-BLM Document 6 Filed 09/26/16 Page 2 of 4 3 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Dated: September 26, 2016 Respectfully Submitted, MARGARET M. DOTZEL Acting General Counsel U.S. Dept. of Health & Human Services ELIZABETH H. DICKINSON Chief Counsel ANNAMARIE KEMPIC Deputy Chief Counsel, Litigation ARIEL Z. SEELEY Associate Chief Counsel U.S. Dept. of Health & Human Services Office of the General Counsel Food and Drug Division 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 (301) 796-8738 (phone) ariel.seeley@fda.hhs.gov BENJAMIN C. MIZER Principal Deputy Assistant Attorney General Civil Division United States Department of Justice JONATHAN F. OLIN Deputy Assistant Attorney General MICHAEL S. BLUME Director, Consumer Protection Branch s/ Monica C. Groat MONICA GROAT Trial Attorney United States Department of Justice Consumer Protection Branch P.O. Box 386 Washington, DC 20044 (202) 532-4218 (phone) (202) 514-8742 (fax) Monica.C.Groat@usdoj.gov Case 3:16-cv-01214-H-BLM Document 6 Filed 09/26/16 Page 3 of 4 4 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 CERTIFICATE OF SERVICE I HEREBY CERTIFY that on September 26, 2016, I filed the foregoing electronically with the Clerk of the Court using the CM/ECF system. I declare under penalty of perjury that the foregoing is true and correct. DATED this 26th day of September, 2016. s/ Monica Groat MONICA GROAT Trial Attorney United States Department of Justice Consumer Protection Branch P.O. Box 386 Washington, DC 20044 (202) 532-4218 (phone) (202) 514-8742 (fax) Monica.C.Groat@usdoj.gov Case 3:16-cv-01214-H-BLM Document 6 Filed 09/26/16 Page 4 of 4 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 BENJAMIN C. MIZER Principal Deputy Assistant Attorney General JONATHAN F. OLIN Deputy Assistant Attorney General Civil Division U.S. Department of Justice MICHAEL S. BLUME, Director MONICA GROAT, Trial Attorney Virginia Bar No. 80421 Consumer Protection Branch U.S. Department of Justice P.O. Box 386 Washington, D.C. 20044 (202) 532-4218 (phone) (202) 514-8742 (fax) Monica.C.Groat@usdoj.gov Attorney for Defendants UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF CALIFORNIA DANIEL KRIPKE, on behalf of ) himself and the general public, ) ) Plaintiff, ) ) v. ) Case No: 3:16-cv-1214-H-BLM ) UNITED STATES FOOD AND ) Memorandum in Support of Motion to DRUG ADMINISTRATION; ) Dismiss ROBERT M. CALIFF, ) in his official capacity as ) Judge: The Honorable Marilyn L. Commissioner, United States Food ) Huff and Drug Administration; UNITED ) Location: Courtroom 15A STATES CENTER FOR DRUG ) EVALUATION AND RESEARCH; ) JANET WOODCOCK, in her official ) capacity as Director, United States ) Center for Drug Evaluation and ) Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 1 of 27 2 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Research; UNITED STATES ) DEPARTMENT OF HEALTH AND ) HUMAN SERVICES; and SYLVIA ) MATTHEWS BURWELL, in her ) official capacity as Secretary, United ) States Department of Health and ) Human Services, ) ) Defendants. ) _______________________________) MEMORANDUM IN SUPPORT OF DEFENDANTS’ MOTION TO DISMISS Defendants the United States Food and Drug Administration (“FDA”); Robert M. Califf, M.D.; FDA’s Center for Drug Evaluation and Research (“CDER”); Janet Woodcock; the United States Department of Health and Human Services (“HHS”); and Sylvia Matthews Burwell (collectively referred to as “Defendants”), hereby submit this Memorandum in Support of Defendants’ Motion to Dismiss Plaintiff’s Complaint. I. INTRODUCTION Plaintiff Dr. Daniel Kripke, on behalf of himself and the general public, alleges that Defendants have violated the Administrative Procedure Act (“APA”), 5 U.S.C. § 551 et seq., and failed to comply with various statutory provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq. by failing to respond to Plaintiff’s Citizen Petition (“Petition”), which requests that the agency take a number of administrative actions with respect to at least ten drug products (collectively referred to as “Hypnotics”). Compl. [Dkt. #1] ¶¶ 8 and 9. Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 2 of 27 3 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 FDA accepted and filed the Petition on October 27, 2015. Compl. ¶ 13. At the outset, Plaintiff lacks standing to bring this lawsuit. Plaintiff, an Emeritus Professor and researcher, asserts that he has great concern about the dangers Hypnotics pose to the general public, but this general grievance is not a particularized, imminent injury of the sort that is necessary to demonstrate that he has suffered the requisite injury in fact to confer standing. Summers v. Earth Island Inst., 555 U.S. 488, 497 (2009) (“the requirement of injury in fact is a hard floor of Article III jurisdiction . . . .”). Thus, the Court should dismiss this case pursuant to Rule 12(b)(1) for lack of subject-matter jurisdiction. Further, Plaintiff has failed to state a claim on which relief can be granted for unreasonable delay. Plaintiff’s citizen petition was filed less than a year ago, and makes significant, complex requests requiring extensive agency review. FDA has not unreasonably delayed in responding to the Petition. Nor do any of Plaintiff’s additional claims have any merit. Accordingly, Plaintiffs’ claims should also be dismissed pursuant to Rule 12(b)(6) for failure to state a claim. II. BACKGROUND A. Statutory and Regulatory Background The following authorities are relevant to FDA’s consideration of the Petition. 1. Drugs FDA regulates the manufacture, sale, and labeling of prescription drugs Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 3 of 27 4 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 under the FDCA. FDA is charged with determining whether drugs are safe and effective under the conditions prescribed, recommended, or suggested in the labeling, 21 U.S.C. §§ 355(d), 393(b)(2)(B). FDA must approve a drug before it may be lawfully introduced into interstate commerce. 21 U.S.C. § 355(a). To obtain approval to market a new drug, a manufacturer must submit a new drug application (“NDA”) to FDA. 21 U.S.C. § 355(b). In its review of an NDA, FDA weighs the risks and benefits of a drug and ultimately will approve the NDA if it finds, inter alia, that the “drug is safe for use,” and “will have the effect it purports or is represented to have[,] under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.” 21 U.S.C. § 355(d)(1),(5). A manufacturer may submit an Abbreviated New Drug Application (“ANDA”) requesting approval of a generic version of an approved drug product. 21 U.S.C. § 355(j). ANDA applicants need not submit clinical data to demonstrate the safety and efficacy of the generic product, as with an NDA. See id. Rather, an ANDA relies on FDA’s previous findings that the product approved under the NDA is safe and effective. Among other information, an ANDA must include data showing that the generic drug product is bioequivalent to the innovator product. 21 U.S.C. § 355(j)(2)(A)(iv), (j)(4)(F); 21 C.F.R. §§ 314.127(a)(6)(i), 314.94(a)(7). After approval, FDA may reassess a drug’s safety and consider whether changes in the information available justify and meet the statutory criteria for taking regulatory action. FDA may among other things, as appropriate, require Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 4 of 27 5 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 that certain risk evaluation and mitigation strategies (“REMS”) be implemented. 21 U.S.C. § 355-1. 21 U.S.C. §355-1 authorizes FDA to require a REMS for certain drugs if FDA determines, based on new safety information, that a REMS is necessary to ensure that the benefits of the drug outweigh its risks. See 21 U.S.C. § 355-1(2)(a). A REMS can include one or more of the following elements: a Medication Guide, 21 U.S.C. § 355-1(e)(2), a patient package insert, id., and/or a communication plan to health care providers, id. at § 355-1(e)(3). FDA may also require certain elements to assure safe use (“ETASU”) as part of a REMS. 21 U.S.C. § 355-1(f). The ETASU can include, for example, requirements that health care providers who prescribe the drug have particular training or experience, that patients using the drug be monitored, or that the drug be dispensed to patients with evidence or other documentation of safe use conditions. Id. Certain REMS with ETASU may also include an implementation system through which the sponsor is able to monitor and evaluate implementation of the ETASU and work to improve its implementation. 21 U.S.C. § 355-1(f)(4). Finally, the REMS generally must have a timetable for submission of assessments of the strategy. 21 U.S.C. §355-1(d). Drugs that are the subject of ANDAs are subject to certain of the same REMS that are required for the applicable listed drug. 21 U.S.C. § 355-1(i). Such drugs are required to coordinate with the NDA holder to develop a “single, shared system” to implement and monitor the ETASU. See id. § 355-1(i)(1)(B). Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 5 of 27 6 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Once FDA has determined that the benefits of a drug no longer outweigh the risks and notifies the holder of the approved NDA, the holder must submit a proposed REMS for the drug to FDA within 120 days or within a reasonable time, as agreed upon by the parties. 21 U.S.C. § 355-1(a)(2)(B). FDA must review and act on the proposed REMS within 180 days of receipt of the proposed strategy. 21 U.S.C. § 355-1(h)(2)(A)(i). If a risk is common to all members of a drug class, FDA may standardize the approach to managing that risk by encouraging NDA holders to submit REMS proposals that are compatible. See FDA, Draft Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS is Necessary (September 2016), http://www.fda.gov/ucm/groups/fdagov- public/@fdagov-drugs-gen/documents/document/ucm521504.pdf. 2. Citizen Petition Process FDA regulations establish a process by which any interested person may petition the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action. Such petitions, referred to as Citizen Petitions, are governed by regulations found at 21 C.F.R. § 10.30. Under the regulations, the Commissioner must rule on each petition, “taking into consideration (i) available agency resources for the category of subject matter, (ii) the priority assigned to the petition considering both the category of subject matter involved and the overall work of the agency, and (iii) time requirements established by statute.” 21 C.F.R. § 10.30(e)(1). The Commissioner Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 6 of 27 7 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 has three options for responding to a Citizen Petition within 180 days of its receipt: approve the petition, deny the petition, or provide a tentative response indicating why the agency has been unable to reach a decision on the petition. Id. § 10.30(e)(2). The regulations cite the existence of other agency priorities or a need for additional information among the possible grounds for the Commissioner’s inability to approve or deny the petition. See id. Once a tentative response has been issued, there is no deadline required by the regulations for issuing a final response, allowing the agency to allocate resources and rank projects based on its assessment of priority in the face of competing public health needs. See 21 C.F.R. § 10.30. B. Factual Background Plaintiff Dr. Daniel Kripke is an Emeritus Professor at the University of California, San Diego’s Department of Psychiatry. Compl. ¶ 24. He states that he has “conducted and published extensive research into the dangers associated with Hypnotics” throughout his forty-year career. Id. On October 26, 2015, Plaintiff submitted a Citizen Petition to FDA, which FDA filed the following day, October 27, 2015. Compl. ¶ 13. The Petition requests that FDA take a number of administrative actions with respect to at least ten Hypnotics, including “zolpidem, tamazepam, eszopiclone, zalemplon, triazolam, flurazepam, and quazepam, in all brands and forms prescribed to treat insomnia or patient-reported sleep disorders, and any barbiturates still prescribed Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 7 of 27 8 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 including, pentobarbital, amobarbital, and seconbarbital, either on or off-label to induce sleep.” Compl. ¶ 8. Dr. Kripke contends that the risks of these drugs outweigh their benefits. Compl. ¶¶ 9-10. Specifically, the Petition requests that FDA take the following administrative actions for each of the drugs: “(1) require that manufacturers of Hypnotics conduct comprehensive post-market randomized placebo-controlled trials quantifying risks and benefits to patients; (2) require that manufacturers of each of the Hypnotics promptly issue ‘Dear Doctor’ letters regarding the known and suspected risks to patients of long-term use of Hypnotics; (3) implement enhanced reporting of all prescription use of Hypnotics; (4) restrict off-label prescription of Hypnotics; (5) require labeling of mortality hazards on Hypnotics; (6) require enhanced informed consent for Hypnotics; and (7) restrict indications for Hypnotics pending the results of post market studies”1 (collectively referred to as “requested actions”). Compl. ¶ 13. Dr. Kripke asks that FDA take these actions because his research ostensibly demonstrates that “Hypnotics greatly increase all- cause mortality, produce an excess of deaths at night, and cause (1) serious and lethal infections, (2) increased cancer risk, (3) clinical depression, and (4) an increase in the frequency and severity of injuries due to auto collisions, falls, and 1 We note that the Petition contains an eighth requested action, i.e., “[to] relax indications beyond hospice care only if the manufacturer of each of the Hypnotics proves that its product has minimal mortality or cancer risk and has clinically significant benefit.” Kripke, Daniel, Citizen Petition, FDA-2015-P-3959. We do not cite this request here because it was not included in the complaint. FDA, nonetheless, will consider and respond to each of the requested actions in the Petition in its final response. Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 8 of 27 9 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 other accidents” (collectively referred to as “end points”). Compl. ¶ 10. In a letter dated April 21, 2016, FDA responded to Plaintiff’s Citizen Petition with a tentative response, in accordance with 21 C.F.R. § 10.30(e)(2), indicating that the agency was unable to reach a decision on the Petition because “it raises complex issues requiring extensive review and analysis by Agency officials.” Compl. ¶ 15. Plaintiff filed this suit on May 19, 2016. In his complaint, he alleges (1) that FDA’s failure to comply with its statutory duty and take the actions requested in the Petition “constitute actions unlawfully withheld or unreasonably delayed in violation of 5 U.S.C. § 706(1), 21 U.S.C. §§ 351,352, and 355; and 21 C.F.R. § 10.30(e)(1),” Compl. ¶¶ 112-113; (2) that “FDA’s failure to comply with its statutory duty further constitutes an agency action that is ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law,’ in violation of the APA, 5 U.S.C. § 706(2)(a),” Compl. ¶ 114; and (3) that “FDA’s failure to issue a final response [to the Petition] constitutes an agency action unreasonably delayed in violation of the APA, 5 U.S.C. §§ 555(b) and 706(1), and the FDCA’s implementing regulations, 21 C.F.R. § 10.30(e)(1).” Compl. ¶ 117. On August 16, 2016, Plaintiff updated the Petition by submitting a statement to the docket with four additional scientific references. See Docket No. FDA- 2015-P-3959, Kripke, Daniel, “Re: Scientific Update and Response to Comments re Docket No. FDA-2015-P-3959.” Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 9 of 27 10 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 III. Standard of Review A motion to dismiss for lack of subject matter jurisdiction pursuant to Rule 12(b)(1) is premised on the fundamental concept that federal courts are courts of limited jurisdiction. See Vacek v. United States Postal Serv., 447 F.3d 1248, 1250 (9th Cir. 2006). “It is to be presumed that a cause lies outside this limited jurisdiction, and the burden of establishing the contrary rests upon the party asserting jurisdiction.” Id. (quoting Kokkonen v. Guardian Life Ins. Co., 511 U.S. 375, 377 (1994)); see also Lujan v. Defenders of Wildlife, 504 U.S. 555, 561 (1992) (“The party invoking federal jurisdiction bears the burden of establishing these elements.”). At the pleading stage, although the courts “presume that general allegations embrace those specific facts that are necessary to support the claim,” the plaintiff, at a minimum, must allege “general factual allegations of injury resulting from the defendant’s conduct” that justify federal jurisdiction. Lujan, 504 U.S. at 561 (internal quotations omitted). When a plaintiff’s injury arises from the government’s regulation (or lack thereof) of someone else, standing is “substantially more difficult to establish.” Id. at 562. A motion to dismiss for failure to state a claim upon which relief may be granted pursuant to Rule 12(b)(6) challenges whether the plaintiff’s allegations “possess enough heft to show that the pleader is entitled to relief.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 557 (2007) (internal quotation marks omitted). In considering a Rule 12(b)(6) motion, the court must accept the complaint’s factual Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 10 of 27 11 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 allegations as true, and construe them in a light most favorable to the plaintiff. Hannan v. Maxim Integrated Products, Inc., 394 F.App’x. 434, 434 (9th Cir. 2010). However, the court is not bound to “accept as true a legal conclusion couched as a factual allegation.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (internal citations and quotation marks omitted) (quoting Twombly, 550 U.S. at 555). A complaint only will survive a motion to dismiss if it contains “sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face.” Iqbal, 556 U.S. at 678 (internal quotation marks omitted). IV. Argument A. Plaintiff Lacks Article III Standing Article III of the Constitution “limits the jurisdiction of federal courts to ‘Cases’ and ‘Controversies.’” Lujan, 504 U.S. at 559-60. “[S]tanding is an essential and unchanging part of the case-or-controversy requirement of Article III . . . serving to identify those disputes which are appropriately resolved through the judicial process.” Id. at 560 (quoting Whitmore v. Arkansas, 495 U.S. 149, 155 (1990)). In cases where a plaintiff alleges a procedural injury, the plaintiff must still establish Article III standing for the underlying matter. See Summers v. Earth Island Inst., 555 U.S. at 496 (2009) (stating that “deprivation of a procedural right without some concrete interest that is affected by the deprivation . . . is insufficient to create Article III standing.”). Standing, an “irreducible constitutional minimum,” requires that the plaintiff Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 11 of 27 12 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 demonstrate three elements: (1) that he has suffered “an injury in fact,” (2) that is “fairly traceable to the defendant’s allegedly unlawful conduct,” and (3) which is “likely to be redressed by the requested relief.” Lujan, 504 U.S. at 560. To establish the first element, the plaintiff must allege an injury in fact that is “concrete and particularized” and “actual or imminent,” not “conjectural or hypothetical.” Lujan, 504 U.S. at 560. A concrete and particularized claim “affect[s] the plaintiff in a personal and individual way.” See id. at 560 & n.1. 1. Plaintiff Fails to Demonstrate that He has Suffered an “Injury in Fact” Plaintiff fails to allege an injury that is sufficiently concrete and particularized to invoke the Article III jurisdiction of this Court. First, Plaintiff alleges that, over his forty-year career, he has conducted and published “extensive research into the dangers associated with Hypnotics.” Compl. ¶ 24. He does not allege that he takes or intends to take Hypnotics. Plaintiff’s career researching Hypnotics merely demonstrates that he has a longstanding professional interest in the subject area, couched in terms of a “concern about the clear health danger posed to the general public.” Compl. ¶ 95. However, “a mere ‘interest in a problem,’ no matter how longstanding the interest and no matter how qualified . . . is not sufficient[,] by itself,” to establish a concrete injury for standing purposes. Sierra Club v. Morton, 405 U.S. 727, 739 (1972). While laudable, Plaintiff’s “concern” is exactly the type of generalized grievance that the Supreme Court has Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 12 of 27 13 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 consistently held cannot confer standing. See, e.g., Warth v. Seldin, 422 U.S. 490, 499-500 (1975) (stating that “when the asserted harm is a generalized grievance shared in substantially equal measure by all or a large class of citizens, that harm alone normally does not warrant exercise of jurisdiction.”); Lujan, 504 U.S. at 573- 4 (indicating that claims “raising only a generally available grievance about government—claiming only harm to his and every citizen’s interest . . . and seeking relief that no more directly and tangibly benefits him than it does the public at large — do[] not state an Article III case or controversy.”). Relatedly, because Plaintiff does not allege that he takes or intends to take Hypnotics, he has failed to allege an “actual or imminent” injury. Id. at 560; NRDC v. EPA, 735 F.3d 873, 878 (9th Cir. 2013). Any injury from Hypnotics to Plaintiff is purely hypothetical. See, e.g., NRDC v. FDA, 710 F.3d 71, 86 (2d Cir. 2013) (finding that plaintiffs lacked standing to challenge FDA’s regulation of a drug because they did not use products containing the drug at issue and plaintiffs’ concern about general risks to the public associated with exposure to such drug and the proliferation of antibiotic-resistant bacteria was “more like a threatened injury that is contingent and far-off rather than imminent”); Public Citizen, Inc. v. Nat’l Highway Traffic Safety Admin, 489 F.3d 1279, 1293-94 (D.C. Cir. 2007) (holding that plaintiff did not have standing because its allegation that the agency’s regulation of highways, or lack thereof, led to an increased risk of death, physical injury, or property damage from future car accidents was speculative not actual or Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 13 of 27 14 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 imminent); see also Physicians for Integrity in Medical Research, Inc. v. Hamburg, 2014 U.S. App. LEXIS 3412 (9th Cir. 2014) (holding that a physician who did not use or prescribe the medical device at issue did not have standing to sue FDA to remove the medical device from the market). Similarly, in Coalition for Mercury-Free Drugs v. Sebelius, 671 F.3d 1275 (D.C. Cir. 2012), the plaintiffs challenged FDA’s denial of their citizen petition requesting that FDA ban the use of thimerosal, a mercury-based preservative, in vaccines because of a general concern regarding the safety of mercury. The plaintiffs did not receive or intend to receive vaccines with thimerosal and there were mercury-free vaccines readily available. The D.C. Circuit held that plaintiffs did not have standing to bring this challenge because the plaintiffs could not establish that they faced a “certainly impending or even likely[] risk of future physical injury from thimerosal in vaccines.” Id. at 1280. Likewise, Plaintiff has not established a credible threat posed by Hypnotics that he has not stated he uses or intends to use. Finally, it is inappropriate for Plaintiff to bring this challenge on the part of third parties who may regularly use Hypnotics. “Article III judicial power exists only to redress or otherwise protect against injury to the complaining party, even though the court’s judgment may benefit others collaterally.” Warth, 422 U.S. at 499. Accordingly, to have standing, Dr. Kripke must establish that he suffers a Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 14 of 27 15 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 personal, particularized, and imminent injury, which he fails to do. 2 Dr. Kripke has, therefore, failed to allege an injury in fact. He cannot proceed without establishing this required element. See Whitmore v. FEC, 68 F.3d 1212, 1215 (9th Cir. 1995) (“We need not reach the question of whether plaintiffs could establish either of the other two prerequisites for standing, because the absence of any one element required dismissal.”). 2. Plaintiff Fails to Demonstrate the Remaining Standing Requirements Even if Plaintiff had established a particularized and imminent injury related to FDA’s regulation of Hypnotics, which he has not, he has failed to demonstrate the necessary “causal connection between the injury and the conduct complained of” and that this injury is redressable. Lujan, 504 U.S. at 560. The Petition primarily requests that FDA require drug companies to provide additional safety information to health care providers and patients. However, Plaintiff is already familiar with the safety information he wants FDA to require on the labeling 2 Plaintiff purports to bring his complaint as a Class Action on behalf of himself and the general public. Compl. Cover. However, nothing in the complaint establishes the class that Plaintiff claims to represent. The complaint does not allege the necessary predicate facts to sue as a representative on behalf of all members of the class. See Fed. R. Civ. P. § 23(a) (permitting a party to sue on behalf of others if: “(1) class is so numerous that joinder of all members is impracticable, (2) there are questions of law or fact common to the class, (3) that the claims or defense of the representative parties are typical of the claims or defense of the class, and (4) that the representative parties will fairly and adequately protect the interests of the class.”). And, the court must certify the class at “an early practicable time after a person sues . . . as a class.” Id. § (b). To date, this Court has not issued an order certifying a class with Plaintiff as the representative. Nonetheless, even if he had properly established a class, this would not cure the fundamental defect in the instant case: Plaintiff cannot establish a cognizable “injury in fact” that would confer standing. For class actions, standing is satisfied only if at least one named plaintiff meets the requirements for standing. Bates v. Unites Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 15 of 27 16 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 because it is discussed in the Petition. To the extent that Plaintiff has an “injury” related to the conveyance of information he already knows, it is not clear how this “injury” is caused by FDA. Nor is it clear how this so-called “injury” would be redressed by FDA requiring that information he already knows be conveyed to others. Similarly, with respect to Plaintiff’s requests for postmarketing studies and REMS, because Plaintiff has not alleged that he takes or will take Hypnotics, Plaintiff fails to establish any injury to himself due to FDA action, nor does he explain how FDA taking the requested actions would redress any injury. Consequently, because Plaintiff has not established Article III standing, his complaint should be dismissed pursuant to Rule 12(b)(1) for failure to establish subject matter jurisdiction. B. Plaintiff has Failed to State a Claim Upon Which Relief May Be Granted Alternatively, Plaintiff has failed to state a claim, and the complaint should be dismissed for that independent reason. 1. FDA Has Not Unreasonably Delayed Taking Action In cases involving allegations of agency delay, the Ninth Circuit applies the TRAC factors, which were articulated by the D.C. Circuit in Telecommunications Research & Action Center (TRAC) v. FCC, 750 F.2d 70 (D.C. Cir. 1984), and explicitly adopted in In re California Power Exch. Corp., 245 F.3d 1110, 1124 (9th Parcel Service, Inc., 511 F.3d 974, 985 (9th Cir. 2007). As described herein, Plaintiff fails to meet Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 16 of 27 17 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Cir. 2001). See also Brower v. Evans, 257 F.3d 1058, 1068-69 (9th Cir. 2001) (affirming district court’s application of TRAC factors where there was no statutory or regulatory deadline). The TRAC factors urge courts to take into account the following six factors when considering the reasonableness of agency delay: (1) the time agencies take to make decisions must be governed by a rule of reason; (2) where Congress has provided a timetable or other indication of the speed with which it expects the agency to proceed in the enabling statute, that statutory scheme may supply content for this rule of reason; (3) delays that might be reasonable in the sphere of economic regulations are less tolerable when human health and welfare are at stake; (4) the court should consider the effect of expediting delayed action on agency activities of a higher or competing priority; (5) the court should also take into account the nature and extent of the interests prejudiced by the delay; and (6) the court need not find any impropriety lurking behind agency lassitude in order to hold that an agency action is unreasonably delayed. Indep. Mining Co. v. Babbitt, 105 F.3d 502, 507 n. 7 (9th Cir. 1997) (quotation marks and brackets omitted) (quoting TRAC, 750 F.2d at 80). Application of these factors demonstrates that FDA is acting reasonably. For the first and second factors, there is no statutory or regulatory timetable governing the FDA’s response to a Citizen Petition once a tentative response has been issued. See 21 C.F.R. § 10.30(e). Plaintiff argues that FDA’s “tentative response” is “statutorily inadequate,” constituting unreasonable delay because it did not provide a substantive response within the 180 days required for an initial the standing requirements. Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 17 of 27 18 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 response in 21 C.F.R. § 10.30(e)(2). See Compl. ¶¶ 15-17. This argument is premised on a misunderstanding or misrepresentation of FDA’s implementing regulations. First, there is no statutory timeframe in the FDCA that governs FDA’s responses to Citizen Petitions. See generally 21 U.S.C. § 321 et seq. 3 Second, the implementing regulations explicitly permit FDA to satisfy the requirement to respond within 180 days with a response that indicates why the agency has been unable to reach a decision on the petition. See 21 C.F.R. § 10.30(e)(2); see also Ctr. for Science in the Public Interest v. FDA, 74 F. Supp. 3d 295, 301 (D.D.C. 2014) (concluding that the “only applicable standard against which to measure” the timing of FDA’s response to a citizen petition is “the APA’s requirement that FDA act ‘within a reasonable time.’” and citing 5 U.S.C. § 555(b)); Hill Dermaceuticals, Inc. v. FDA, 524 F. Supp. 2d 5, 11 (D.D.C. 2007) (recognizing the sufficiency of a tentative response to a citizen petition). FDA’s “tentative response,” dated April 21, 2016, was sufficient to explain that FDA needed more time to engage with the complex issues raised in the Petition, and satisfied the requirement to respond to 3 Contrary to Plaintiff’s assertion, 21 U.S.C. § 371(e)(1) does not impose a statutory timeframe for Citizen Petition responses. See Compl. ¶ 35. This provision governs “[a]ny action for the issuance, amendment, or repeal of any regulation under section 343(j) [(misbranded food for special dietary uses)], 344(a) [(emergency permit control for food contamination)], 346 [(tolerance for poisonous or deleterious substances in food), 351(b) [(adulterated drug for drugs that fail to meet official compendium standards)], or 352(d) [(repealed)] or (h) [(misbranded drugs that are liable to deterioration)] of this Act [(FDCA)], and any action for the amendment or repeal of any definition and standard of identity under section 341 of this Act for any dairy product . . . .” 21 U.S.C. § 371(e)(1). An interested party may petition the FDA to initiate a rulemaking under the specified provisions and FDA must act on such petitions “as soon as practicable.” Id. However, Plaintiff is not petitioning FDA to issue, amend, or repeal any of the specified types of regulations, and thus whatever timing requirements may be imposed by this provision (if any) are irrelevant to the timing of FDA’s response to the Petition. Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 18 of 27 19 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 the Petition within 180 days. See Biovail Corp. v. FDA, 448 F. Supp. 2d 154, 162 (D.D.C. 2006) (indicating that FDA’s tentative response did not need to provide more detail because the regulation “does not indicate that the FDA’s reasoning must be of a certain degree of detail”). Whether delay is unreasonable “cannot be decided in the abstract, by reference to some number of months or years beyond which agency inaction is presumed to be unlawful, but will depend in large part . . . upon the complexity of the task at hand, the significance (and permanence) of the outcome, and the resources available to the agency.” See Mashpee Wampanoag Tribal Council, Inc. v. Norton, 336 F.3d 1094, 1102 (D.C. Cir. 2003); Ctr. for Science in the Public Interest, 74 F. Supp. 3d at 301 (stating that whether an agency had unreasonably delayed a petition response “can only be measured by reference to the complexity of the task;” i.e., “[t]he more complex the petition, the more time an agency may need to adequately respond”). Thus, the timing of FDA’s ultimate response to a Citizen Petition depends on the complexity of the issues raised and the agency’s statutory priorities at the time. The Supreme Court has held that FDA is “far better equipped than the courts to deal with the many variables involved in the proper ordering of its priorities.” Heckler v. Chaney, 470 U.S. 821, 831 (1985); see also Massachusetts v. EPA, 549 U.S. 497, 527 (2007) (stating that an agency has “broad discretion to choose how best to marshal its limited resources”). Furthermore, good agency decisionmaking, especially related to complex matters of evolving Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 19 of 27 20 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 science, takes time, and FDA should be permitted to conduct the analysis necessary to develop scientific bases for the actions it takes. See In re United Mine Workers of America Int’l Union, 190 F.3d 545, 551-56 (D.C. Cir. 1999) (stating that “it is difficult for us to second-guess” the agency’s time projections “in light of the host of complex scientific and technical issues involved”). Moreover, hurrying a decisionmaking is not in the public interest as no research, reasoned analysis, or robust explanation can be properly completed for such a large number of issues on an abbreviated time line. See United Steel Workers of America v. Rubber Mfrs. Ass’n, 783 F.2d 1117, 1120 (D.C. Cir. 1986) (stating that “judicial imposition of an overly hasty timetable at this stage would ill serve the public interest”). Plaintiff submitted the Petition less than one year ago and supplemented his submission with additional scientific references less than two months ago. The Petition requests that the agency take seven different actions with respect to at least ten different drug products. To properly respond to the Petition, FDA must consider the information provided with the Petition, including all cited studies and each end point, as well as research the issues to determine the appropriate response. These scientific analyses are complicated and must be completed for each drug product. And FDA’s response to this Petition is just one of a multitude of actions that the agency is currently handling. It is patently unreasonable to expect that FDA would be able to provide a thorough and well-reasoned response for each drug product and grant or deny the requested actions in the brief time that Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 20 of 27 21 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 has elapsed. Indeed, FDA has not had sufficient time to complete the requested actions. For example, the statutory time frames for establishing a REMS involve 120 days for the NDA holder to propose a REMS and 180 days for FDA to respond to the proposal. It can take nearly one year, and perhaps even longer, for the agency and applicant holder to establish an appropriate REMS. And this process can take even longer if the REMS involves drugs subject to an ANDA and/or if the REMS is for Hypnotics (or a subset of them) as a class because to establish such a REMS, multiple manufacturers with competing priorities will need to cooperate. Even if FDA ignored all other priorities and hastily worked to establish a REMS for any of the Hypnotics in the Petition, the regulatory process would still be ongoing. In light of the complexity of the issues raised, the number of drug products and end points to be evaluated, the number of requested actions, the obligations on FDA to justify its actions, and the practical considerations of interacting with manufacturers to establish appropriate postmarket action, the timing of FDA’s consideration of these issues fully satisfies the “rule of reason.” For the third and fourth factors, the Petition’s inclusion of an issue of public health and safety does not make the timing of FDA’s consideration unreasonable. In In re Pesticide Action Network North America, 532 F. App’x. 649 (9th Cir. 2013), the Ninth Circuit applied the TRAC factors and determined that six years was not an unreasonable delay for a petition response given the complexity of the Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 21 of 27 22 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 scientific questions posed, the agency’s other priorities, and the lack of statutory deadline. As part of this decision, the Ninth Circuit recognized that EPA, “by its nature, regulates almost entirely in the realm of human health and welfare.” Id. at 651. The court, therefore, did not find that the presence of possible public health harm mandated an expedited response. Id. The same is true of FDA. The vast majority of FDA’s workload can fairly be described as involving issues of “human health and welfare.” 4 The agency faces difficult decisions every day regarding how to allocate its resources in the face of competing demands from a long list of critical public health initiatives. Any action taken on the Petition comes at the expense of delay to other FDA action, which also will likely have a public health component. As stated previously, FDA is in the best position to weigh these considerations, order its priorities, and apply its limited to resources in a manner that takes into account all of these demands. For the fifth factor, Plaintiff has not demonstrated that he will be prejudiced by waiting for FDA to complete its analysis of the Petition. As discussed supra Section IV.A., Plaintiff has not even alleged that he takes or intends to take Hypnotics, and he will suffer no personal injury awaiting a response to the petition. Moreover, Plaintiff already knows the information he wants FDA to require be conveyed about the risks of Hypnotics, so any passage of time before FDA 4 See FDA’s Mission Statement, 21 U.S.C. § 393 (“The Administration shall . . . [among other things] . . . protect the public health by ensuring that . . . human and veterinary drugs are safe and effective.”). Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 22 of 27 23 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 determines whether such information should be required will not cause him any prejudice. Finally, the sixth factor, the existence of agency “impropriety,” does not favor Plaintiff. He has not alleged that FDA has acted improperly, nor has he presented facts to contradict “the well-established presumption that public officials . . . act in good faith and are conscientiously proper in the discharge of their duties.” Beyond Pesticides/ Nat’l Coalition Against the Misuse of Pesticides v. Johnson, 407 F. Supp. 2d 38, 41 (D.D.C. 2005) (quoting Bayshore Res. Co. v. United States, 2 Cl. Ct. 625, 632 n.4 (1983)). Taken together, these factors demonstrate that FDA’s treatment of the Petition was not unreasonable, and Plaintiff’s claim for unreasonable delay is not plausible in these circumstances. Plaintiff has no authority to dictate FDA’s regulatory priorities (or their pace); and thus, Plaintiff’s request for judicial intervention should be dismissed under Rule 12(b)(6) for failure to state a claim upon which relief may be granted. 2. Plaintiffs’ Additional Claims For Relief Also Fail Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 23 of 27 24 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Plaintiff also asserts that (1) FDA action is unlawfully withheld under 5 U.S.C. § 706(1), and FDA has a “statutory duty” to take the actions in the petition or on its own initiative; and (2) FDA’s failure to comply with its “statutory duty” is arbitrary and capricious. Compl. ¶¶ 18-19. These claims are not valid and may be dismissed outright.5 “A claim under § 706(1) can proceed only where a plaintiff asserts that an agency failed to take a discrete agency action that it is required to take.” See Norton v. S. Utah Wilderness Alliance, 542 U.S. 55, 63 (2004) (emphasis in original). “The limitation to required agency action rules out judicial direction of even discrete agency action that is not demanded by law.” Id. Plaintiff tries in vain to identify a statutory “duty” to enforce against FDA. He asserts that FDA has failed to uphold its mission to “protect the public health by ensur[ing] that . . . human . . . drugs are safe and effective . . . .” Compl. ¶ 107 (quoting 21 U.S.C. § 393(b)(1)). That general mission statement does not compel any particular outcome that Plaintiff seeks. See NRDC, Inc. v. FDA, 760 F.3d 151, 178 (2d Cir. 2014) (“Of course, this broad statutory mandate to ‘promote the public health’ and ‘ensur[e] that human and veterinary drugs are safe and effective’ does not compel the agency to use any particular method to attain those goals. After all, ‘no 5 Although not discussed in detail herein, Plaintiff’s complaint requests inter alia that the court compel FDA to take the actions requested in the Petition. Compl. ¶ IX. C. This is an impermissible request. Even if this Court finds that Plaintiff has standing to bring this challenge and determines that FDA unreasonably delayed its response to the Petition, which it should not, the Court can only order FDA to act within a certain time. See Norton v. So. Utah Wilderness Alliance, 542 U.S. 55, 65 (2004). The Court “has no power to specify what the [agency’s] action must be.” Id. Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 24 of 27 25 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 legislation pursues its purposes at all costs . . . and it frustrates rather than effectuates legislative intent simplistically to assume that whatever furthers the statute’s primary objective must be the law.’”) (quoting Rodriguez v. United States, 480 U.S. 522, 525-26 (1987)). Plaintiff also attempts to establish that FDA has a statutory “duty” to “ensure[] that the benefits of [a drug submitted for FDA approval] outweigh the risks of the drug.” Compl. ¶ 109 (quoting 21 U.S.C. § 355-1(a)(1)). The cited provision authorizes FDA, in its discretion, to impose certain postmarketing requirements on sponsors. It does not, as Plaintiff asserts, impose a duty on FDA to reach a particular outcome that is enforceable by a third party. In addition, Plaintiff’s attempt to compel agency action under 21 U.S.C. §§ 351 and 352 fails as an impermissible private right of action. See Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349 n. 4 (2001) (“The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with [FDCA] provisions: ‘All such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.’ 21 U.S.C. § 337(a).”). Private litigants cannot dictate agency enforcement actions against misbranded or adulterated products.6 Id. Accordingly, Plaintiffs’ additional claims for relief may be dismissed for failure to state a claim. Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 25 of 27 26 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 CONCLUSION For the foregoing reasons, this Court should dismiss Plaintiff’s complaint. 6 Nor is it at all clear how adulteration under 21 U.S.C. § 351 concerns Plaintiff, as neither the complaint nor the Petition raises any issue concerning adulteration. Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 26 of 27 27 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Dated: September 26, 2016 Respectfully Submitted, MARGARET M. DOTZEL Acting General Counsel U.S. Dept. of Health & Human Services ELIZABETH H. DICKINSON Chief Counsel ANNAMARIE KEMPIC Deputy Chief Counsel, Litigation ARIEL Z. SEELEY Associate Chief Counsel U.S. Dept. of Health & Human Services Office of the General Counsel Food and Drug Division 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 (301) 796-8738 (phone) ariel.seeley@fda.hhs.gov BENJAMIN C. MIZER Principal Deputy Assistant Attorney General Civil Division United States Department of Justice JONATHAN F. OLIN Deputy Assistant Attorney General MICHAEL S. BLUME Director, Consumer Protection Branch s/ Monica C. Groat MONICA GROAT Trial Attorney United States Department of Justice Consumer Protection Branch P.O. Box 386 Washington, DC 20044 (202) 532-4218 (phone) (202) 514-8742 (fax) Monica.C.Groat@usdoj.gov Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 27 of 27