Montgomery County v. Leavitt (445 F. Supp. 2d 505, 2006)

MEMORANDUM OPINION

WILLIAMS, District Judge.

This action involves a suit by Montgomery County, Maryland (“County” or “Plaintiff’) against Mike Leavitt (“Leavitt”), Secretary of Health and Human Resources, and Andrew C. von Eschenbach (“Esehen-bach”), Acting Commissioner of the United States Food and Drug Administration (collectively, “Defendants”). The Complaint alleges that Defendants acted arbitrarily, capriciously, and abused their discretion, and otherwise acted in violation of 5 U.S.C. § 706, by failing to provide the County with a limited certification for a waiver under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) to implement a Canadian prescription drug reimportation program. The County also requests mandamus relief pursuant to 28 U.S.C. § 136, demanding that Leavitt discharge his “non-discretionary duty” to certify importation of Canadian prescription drugs under the MMA. Now pending before the court is Defendants’ Motion to Dismiss [5]. The Court has reviewed the entire record, as well as the pleadings with respect to the instant motion. No hearing is deemed necessary. See Local Rule 105.6 (D.Md.2004). For the reasons set forth below, the Court will grant Defendants’ Motion to Dismiss.

I. FACTUAL AND PROCEDURAL BACKGROUND

In a letter dated October 10, 2005, County Executive Douglas M. Duncan, on behalf of Montgomery County, requested that Secretary Leavitt issue a waiver pursuant to the MMA to allow the residents of the County and its government to import prescription medications from Canada. (County Letter at 1.) The letter spoke of residents of Montgomery County who are forced to “choose between their health and putting food on the table” and stated that, while drug safety is a “first priority,” the County believed it to be “fundamentally unfair that people living in Canada pay a fraction of what Americans pay for the same prescription.” (County Letter at 1.)

Randall Lutter, the FDA’s Acting Associate Commissioner for Policy and Planning, responded to the waiver request in a letter to Mr. Duncan, dated November 8, 2005. The FDA’s response expressed concerns about the safety risks associated with the importation of prescription drugs from foreign countries, claiming that “many drugs that U.S. Consumers purchase from Canada and believe were made in Canada in fact originate from other countries such as India and Costa Rica.” (FDA Letter at 1.) The letter also described the relevant provisions set forth in the Federal Food, Drug and Cosmetic Act (“FDCA”) and asserted that “it is virtually certain that a foreign wholesaler or pharmacy would fail to comply with these applicable requirements, and therefore virtually every importation of such drugs would violate federal law.” (FDA Letter at 1-2.) The letter mentioned prior communications between the Montgomery County Council and the FDA regarding the County’s program, including the FDA’s prior warning that the proposed program would not comply with the FDCA. (FDA Letter at 4.) Finally, the FDA letter pointed out that section 384 of the MMA “retains the requirement ... that FDA may make effective a program for the importation of drugs by pharmacists and wholesalers only if the Secretary of Health and Human Services (“HHS”) first certifies that implementing the program would (1) pose no additional risk to the public health and safety and (2) result in a significant reduction in the cost of drugs to the American consumer.” (FDA Letter at 5) (citing 21 U.S.C. § 884). The FDA letter concluded that this certification requirement applies to the entirety of section 384, including the individual waiver provision, that it, therefore, “does not authorize a specific waiver for a discrete state pilot program,” and, as a result, granting such a waiver would violate federal law. (FDA Letter at 5.)

On February 23, 2006, Montgomery County filed its Complaint with the United States District Court for the District of Maryland, alleging a violation of 5 U.S.C. § 706 and requesting mandamus relief pursuant to 28 U.S.C. § 136. Defendants filed a Motion to Dismiss Plaintiffs Complaint on April 26, 2006, and Plaintiff filed its Opposition to the Defendant’s Motion on May 19, 2006. On June 2, 2006 Defendants filed their Reply.

II STANDARD OF REVIEW FOR A MOTION TO DISMISS

A court may grant a 12(b)(6) motion to dismiss for failure to state a claim upon which relief can be granted if “it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief.” Conley v. Gibson, 355 U.S. 41, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957). When reviewing a motion to dismiss, a court assumes “the truth of all facts alleged in the complaint and the existence of any fact that can be proved, consistent with the complaint’s allegations” and examines only the legal sufficiency of the complaint. Conley v. Gibson, 355 U.S. 41, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957). While the court must view the facts in a light most favorable to the plaintiff, the court “need not accept the legal conclusions drawn from the facts,” nor should it “accept as ti-ue unwarranted inferences, unreasonable conclusions, or arguments.” Eastern Shore Markets, Inc. v. J.D. Associates Ltd. Partnership, 213 F.3d 175 (4th Cir.2000).

III. ANALYSIS

Montgomery County alleges that the FDA’s decision to deny their waiver request for a Canadian drug importation program violated 5 U.S.C. § 706(2)(a), that the Secretary’s failure to issue certification under 384(i) violated 5 U.S.C. § 706(2)(a), and that Mandamus relief is warranted because Defendants have failed to discharge their official duties. The Court will address these arguments in turn.

A. FDA’S DENIAL OF THE COUNTY’S WAIVER REQUEST WAS IN COMPLIANCE WITH APPLICABLE LAW AND, THEREFOR, NO RELIEF CAN BE GRANTED WITH REGARD TO THIS CLAIM.

a. Standard of Review For Administrative Agency Action

Section 701(a) of the Administrative Procedure Act (“APA”) provides that each agency or “authority of the government of the United States” is subject to judicial review except where “(1) statutes preclude judicial review; or (2) agency action is committed to agency discretion by law.” 5 U.S.C. § 701(a). In elaborating upon the second exception, the Supreme Court explained that “review is not to be had if the statute is drawn so that a court would have no meaningful standard against which to judge the agency’s exercise of discretion.” Heckler v. Chaney, 470 U.S. 821, 830, 105 S.Ct. 1649, 84 L.Ed.2d 714 (1985); see also Collins Music Co., Inc. v. United States, 21 F.3d 1330, 1335 (4th Cir.1994). 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 a relevant statute.” Id. at § 702. Under the APA, the standard of review for challenging administrative agency action is whether the agency’s decision was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law.” Id. at § 706(2)(a); see Zeneca, Inc. v. Shalala, 213 F.3d 161 (4th Cir.2000). The Supreme Court has interpreted this to be a narrow standard, holding that courts, in determining whether or not an agency has violated section 706(2)(a), have “only the limited, albeit important, task of reviewing agency action to determine whether the agency conformed with controlling statutes.” Baltimore Gas & Elec. Co. v. Natural Resources Defense Council, Inc., 462 U.S. 87, 97, 103 S.Ct. 2246, 76 L.Ed.2d 437; see also Wilson v. Office of Civilian Health and Medical Programs of Uninformed Services, 65 F.3d 361, 364 (4th Cir.1995). In this vein, the Fourth Circuit has repeatedly emphasized that the reviewing court “is not empowered to substitute its judgment for that of the agency.” E.g., Zeneca, Inc., 213 F.3d at 167 (quoting Citizens to Preserve Overton Park, Inc. v. Brinegar, 494 F.2d 1212 (6th Cir.1974)). The Supreme Court noted in Consolo v. Federal Maritime Commission, 383 U.S. 607, 620, 86 S.Ct. 1018, 16 L.Ed.2d 131 (1966) that Congress deliberately adopted this standard of review because “it frees the reviewing courts of the time consuming and difficult task of weighing evidence, it gives the proper respect to the expertise of the administrative tribunal and it helps promote the uniform application of the statute.”

b. Statutory Background

i. Federal Food, Drug and Cosmetic Act

The FDCA establishes the Food and Drug Administration’s (“FDA”) comprehensive regulation of the manufacture, marketing, shipment, and labeling of drugs made in the United States. 21 U.S.C. § 301. Among other regulations, the FDCA stipulates that all “new drugs” must be approved by the FDA before they are marketed. Id. at §§ 321(p), 331(d), 355(a). To obtain such approval, a drug sponsor must establish, through carefully conducted clinical trials and other data, that the drug is safe and effective for each of its intended uses. Id. at § 355(b); 21 C.F.R. Part 314. Aso included in the approval process is an examination by the FDA of the manufacturing process and facilities, ingredients, strength and dosage form of the drug, containers, and labeling. Id. at §§ 355(b)(1)(D), (d); 21 C.F.R. § 314.50. Even if a manufacturer has obtained approval for a drug, the version that the manufacturer produces for a foreign market is an unapproved drug if it has not been manufactured according to FDA stipulations, including those regarding packaging, dosage, and labeling requirements. Id. at §§ 331(a), (d); 21 C.F.R. § 314.50. Furthermore, anyone other than the original manufacturer who re-imports or causes the re-importation of FDA-approved drugs originally manufactured in the United States violates the FDCA. Id. at §§ 381(d)(1), 331(t).

ii. Medicare Prescription Drug, Improvement, and Modernization Act

The Medicare Prescription Drug, Improvement, and Modernization Act (“MMA”) was passed by Congress in 2003. The Act provides that the Secretary of Health and Human Services, “after consultation with the United States Trade Representative and the Commissioner of Customs, shall promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States.” 21 U.S.C. § 384(b). The MMA also contains a provision allowing the Secretary to authorize waivers for individual importation: “The Secretary may grant to individuals, by regulation or on a case-by-case basis, a waiver of the prohibition of importation of a prescription drug or device or class of prescription drugs or devices, under such conditions as the Secretary determines to be appropriate.” Id. at § 384(j)(2). Section 384(i) of the MMA, however, requires certification by the Secretary of Health and Human Services before these provisions can take effect: “[t]his section shall become effective only if the Secretary certifies to the Congress that the implementation of this section will (A) pose no additional risk to the public’s health and safety; and (B) result in significant reduction in the cost of covered products to the American consumer.” Id. at § 384(i). To date, the present Secretary, Michael Leavitt, as well as his predecessors, have failed to issue a certification under the MMA or the similarly designed MEDS Act.

c. The FDA’s Decision Not To Grant The County’s Waiver Request Was Not Arbitrary, Capricious, Or Otherwise Not In Accordance With the Law Because The FDA Was Legally Obliged To Deny The Request.

In this case, Plaintiff does not allege that its proposed program would comply with the FDCA but, rather, asserts that the FDA’s decision to deny its waiver request for a Canadian prescription drug reimportation program under § 384(j)(2) of the MMA was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law.” 5 U.S.C. § 706(2)(a); (ComplJ 2.) In pursuit of this claim, Plaintiff attempts three avenues of argument to address the language of 384(i), which requires the Secretary to issue a certification of safety and cost-effectiveness before 384 goes into effect. First, the County argues that the language of 384(i) does not refer to subsection