ORDER ON PARTIES' COMPETING MOTIONS ON FACIAL PREEMPTION

NANCY TORRESEN, Chief Judge.

Before the Court are the parties' competing motions for judgment on the pleadings pursuant to Federal Rule of Civil Procedure 12(c) (ECF Nos. 46, 57). For the reasons stated below, the Plaintiffs' motion is GRANTED and the Defendants' motion is DENIED.

PROCEDURAL HISTORY

Two licensed Maine pharmacists and three trade organizations representing the interests of Maine pharmacists (the "Plaintiffs") bring suit against Janet Mills and Richard Rosen, in their official capacities (the "Defendants" or the "State"), pursuant to the Supremacy Clause, U.S. Const. art. VI, cl. 2, and 42 U.S.C. § 1983. The Plaintiffs claim that the federal Food, Drug, and Cosmetics Act (the "FDCA"), 21 U.S.C. §§ 301-399f, preempts certain amendments to the Maine Pharmacy Act (the "MPA"), 32 M.R.S. §§ 13701-13847.

This Court issued an order on the Defendants' motion to dismiss pursuant to Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6), disposing of the Plaintiffs' Foreign Commerce Clause claim and dismissing the Pharmaceutical Research and Manufacturers of America from this suit. See Order on Mot. to Dismiss (ECF No. 39). Shortly thereafter, the Plaintiffs moved for summary judgment (ECF No. 46), and the Defendants responded by asking this Court either to deny the motion or continue the matter so they could conduct limited discovery (ECF No. 50). The Plaintiffs countered by asserting that no discovery was necessary to resolve their "purely legal" challenge to the Maine legislation. Pls.' Summ. J. Reply & Fed. R.Civ.P. 56(d) Opp'n 1, 14 (ECF No. 51).

The Court called a conference of counsel and determined that it could resolve whether the Plaintiffs are entitled to declaratory relief on their facial preemption challenge without discovery. Report of Conf. of Counsel & Order 2 (ECF No. 56).2 The Court also determined that it would treat the Plaintiffs' motion for summary judgment as a motion for judgment on the pleadings pursuant to Federal Rule of Civil Procedure 12(c) and disregard any facts that would be properly considered at summary judgment, after the benefit of discovery. Report of Conf. of Counsel & Order 2.3 The Defendants thereafter filed their own cross-motion for judgment on the pleadings. Defs.' Mem. in Opp'n to Pls.' Mot. for J. on the Pleadings & Cross-Mot. for J. on the Pleadings (ECF No. 57). The Court now resolves the parties' competing motions on the facial preemption question.4

LEGAL STANDARD

"The court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(a). This standard applies with equal force where parties file cross-motions for summary judgment, in which case the court's role is to "`determine whether either of the parties deserves judgment as a matter of law on [the] facts that are not disputed.'" Showtime Entm't, LLC, 769 F.3d at 69 (quoting Wightman v. Springfield Terminal Ry. Co., 100 F.3d 228, 230 (1st Cir. 1996)). Because this is a facial challenge to the Maine legislation, and no discovery has taken place, the Court decides this matter by the terms of the relevant statutes, without any information about the effects of the Maine legislation or how it is being enforced. See N.H. Motor Transp. Ass'n, 301 F.Supp.2d at 41.

DISCUSSION

I. The Statutory Background

A. The MPA Amendments

In 2013, the Maine legislature passed, without the Governor's signature, "An Act To Facilitate the Personal Importation of Prescription Drugs from International Mail Order Prescription Pharmacies." 2013 Me. Legis. Serv. ch. 373 (S.P.60) (L.D.171) (West) (effective Oct. 9, 2013) (the "MPA Amendments"). The Maine Pharmacy Act generally requires those who "engage in the practice of pharmacy" to be licensed. 32 M.R.S. § 13731(1). The MPA Amendments, which exempt certain entities from the licensing requirement, provide:

Id.

The MPA Amendments also include a "Consumer Choice Preserved" provision, which states:

32 M.R.S. § 13799.

The sponsor of the MPA Amendments explained that because "frequently prescriptions from Canada are far less expensive than those from the United States," the purpose of the Act was to "expand[] the definition of a `mail order prescription pharmacy' under the Maine Pharmacy Act to include an entity located outside of the United States that dispenses prescription medications by mail or carrier from a facility not located in this State to a pharmacy or to a patient who resides in this State." Testimony from Senator Troy Jackson in Support of L.D. 171, An Act to Facilitate the Licensing of International Mail Order Prescription Pharmacies by the Maine Board of Pharmacy: Hearing on L.D. 171 Before the J. Standing Comm. on Labor, Commerce, Research and Econ. Dev., 126th Legis., 1st Sess. (Me.2013).

B. The FDCA

The FDCA creates a regulatory scheme that sets limits on the importation of prescription drugs from other countries. Specifically, the FDCA prohibits the importation or introduction into interstate commerce of any "new drug" that has not received FDA approval, 21 U.S.C. § 355, of any prescription drug not labeled as required by federal law, 21 U.S.C. § 352, 353, and of any prescription drug dispensed without a valid prescription issued by a licensed practitioner, 21 U.S.C. § 353(b). The FDCA also restricts the importation of "American goods returned," by prohibiting any person other than the original manufacturer from importing a prescription drug that was originally manufactured in the United States and sent abroad. 21 U.S.C. § 381(d)(1).

In 2003, Congress enacted the Medicare Prescription Drug, Improvement, and Modernization Act (the "MMA"), which contemplated the promulgation of "regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States." Pub. L. No. 108-173, § 1121, 117 Stat. 2066, 2464 (codified at 21 U.S.C. § 384(b)). This portion of the MMA only takes effect when the Secretary of Health and Human Services certifies that such importation will be safe and cost-effective. 21 U.S.C. § 384(l). No Secretary has supplied that certification, and thus no regulations permitting such importation have issued. See 21 U.S.C. §§ 301-369.

II. The Parties' Positions

A. The State's Position

The State contends that the MPA Amendments simply reduce the reach of the MPA and that it is within its authority as a sovereign to choose not to regulate certain conduct. To hold otherwise, the State asserts, would violate the Tenth Amendment principle that states may not be compelled to administer federal regulatory programs. Printz v. United States, 521 U.S. 898, 935, 117 S.Ct. 2365, 138 L.Ed.2d 914 (1997). In other words, "Maine is leaving to the federal government the enforcement of any federal laws that regulate the sale of prescription drugs to Mainers by pharmacies located in certain foreign countries." Defs.' Reply Mem. in Supp. of their Cross-Mot. for J. on the Pleadings 2 (ECF No. 60).5

B. The Plaintiffs' Position

The Plaintiffs contend that the FDCA creates a comprehensive and "closed" regulatory scheme, which strictly limits the introduction of prescription drugs into interstate commerce. The Plaintiffs also point out that Congress contemplated the potential importation of prescription drugs from Canada in the MMA, but that this section has not taken effect because the Secretary has not granted the necessary certification. See 21 U.S.C. § 384(l). The Plaintiffs assert that the FDCA preempts the MPA Amendments pursuant to the Supremacy Clause. The Plaintiffs offer three distinct theories of preemption — field preemption, direct conflict, and obstacle preemption.

III. The Governing Law

A. Facial Challenges

As plead, the Plaintiffs are only bringing a facial challenge to the MPA Amendments. The Supreme Court has instructed that "[a] facial challenge to a legislative Act is, of course, the most difficult challenge to mount successfully, since the challenger must establish that no set of circumstances exists under which the Act would be valid." United States v. Salerno, 481 U.S. 739, 745, 107 S.Ct. 2095, 95 L.Ed.2d 697 (1987); see also Thayer v. City of Worcester, 755 F.3d 60, 71 n. 3 (1st Cir.2014) (citing Salerno as the applicable standard for non-speech-related facial challenges). "The existence of a hypothetical or potential conflict is insufficient to warrant the pre-emption of the state statute." Rice v. Norman Williams Co., 458 U.S. 654, 659, 102 S.Ct. 3294, 73 L.Ed.2d 1042 (1982). In addition, the Court must avoid declaring the MPA Amendments unconstitutional where a constitutionally permissible construction is available. See Vaquería Tres Monjitas, Inc. v. Pagan, 748 F.3d 21, 26 (1st Cir.2014).

B. Preemption

1. General Framework

To understand the theory behind preemption, it is helpful to step back, as the Supreme Court recently did, and review the basics of federalism:

Arizona v. United States, ___ U.S. ___, 132 S.Ct. 2492, 2500, 183 L.Ed.2d 351 (2012) (citations omitted).

There are a number of ways in which federal law may preempt state law. First, Congress can expressly state that it is preempting state law. Gade v. Nat'l Solid Wastes Mgmt. Assoc., 505 U.S. 88, 98, 112 S.Ct. 2374, 120 L.Ed.2d 73 (1992). Second, the courts may find that although Congress did not expressly preempt state law, preemption can be inferred. See In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.3d 34, 35 (1st Cir.2015). There are, it appears, two variants of implied preemption, which have come to be known as "field" and "conflict" preemption. Id. Field preemption occurs when "[t]he intent to displace state law altogether can be inferred from a framework of regulation `so pervasive ... that Congress left no room for the States to supplement it' or where there is a `federal interest ... so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject.'" Arizona, 132 S.Ct. at 2501 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 91 L.Ed. 1447 (1947)). Conflict preemption is sometimes further broken down into "impossibility" preemption and "obstacle" preemption. Impossibility preemption occurs "where `compliance with both federal and state regulations is a physical impossibility....'" Id. (quoting Fla. Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43, 83 S.Ct. 1210, 10 L.Ed.2d 248 (1963)). Obstacle preemption occurs where "the challenged state law `stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.'" Arizona, 132 S.Ct. at 2501 (quoting Hines v. Davidowitz, 312 U.S. 52, 67, 61 S.Ct. 399, 85 L.Ed. 581 (1941)). However, the Supreme Court has acknowledged that these "pre-emption categories are not `rigidly distinct.'" Gade, 505 U.S. at 104 n. 2, 112 S.Ct. 2374 (quoting English v. Gen. Elec. Co., 496 U.S. 72, 79 n. 5, 110 S.Ct. 2270, 110 L.Ed.2d 65 (1990)).

2. Competing Presumptions

The Court must consider two competing presumptions regarding preemption. On the one hand, the Court must begin with the "presumption that the state statute is valid," Pharm. Research & Mfrs. of Am. v. Walsh, 538 U.S. 644, 661, 123 S.Ct. 1855, 155 L.Ed.2d 889 (2003), particularly if it regulates matters of public health, see Hillsborough Cnty., Fla. v. Automated Med. Lab., Inc., 471 U.S. 707, 718, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985). There is a presumption against preemption "in any field in which there is a history of state law regulation, even if there is also a history of federal regulation." In re Pharm. Indus. Average Wholesale Price Litig., 582 F.3d 156, 178 (1st Cir.2009) (citing Wyeth, 555 U.S. at 565 n. 3, 129 S.Ct. 1187). If a state law regulates in an area of traditional local concern, Congress must make its intent to preempt that state law clear. Nat'l Foreign Trade Council v. Natsios, 181 F.3d 38, 73 (1st Cir.1999) (citing Rice, 331 U.S. at 230, 67 S.Ct. 1146). For example, in Hillsborough County, the Supreme Court held that local ordinances regulating blood plasma donation were not preempted by federal standards also governing blood plasma donation under a theory of field preemption. 471 U.S. at 723, 105 S.Ct. 2371. There, the comprehensiveness of the FDA's regulations was not enough to overcome the presumption against preemption for "state or local regulation of matters related to health and safety." Id. at 715, 105 S.Ct. 2371.

The Plaintiffs, on the other hand, argue that a competing presumption in favor of preemption should apply because the MPA Amendments touch on foreign affairs and thus the state is acting in an area traditionally reserved to the federal government. Natsios, 181 F.3d at 73, 77 (finding preemption where state legislation affected foreign affairs), aff'd on other grounds sub nom. Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 120 S.Ct. 2288, 147 L.Ed.2d 352 (2000).6 This presumption in favor of preemption where a state legislates in the traditional federal area of foreign affairs is based in part on a need for federal uniformity regarding foreign commerce, which is "pre-eminently a matter of national concern." Japan Line, Ltd. v. Los Angeles Cnty., 441 U.S. 434, 448, 99 S.Ct. 1813, 60 L.Ed.2d 336 (1979); see also Hines, 312 U.S. at 63, 61 S.Ct. 399 ("Our system of government is such that the interest of the cities, counties and states, no less than the interest of the people of the whole nation, imperatively requires that federal power in the field affecting foreign relations be left entirely free from local interference."). If Congress has spoken with respect to foreign commerce, any state law that compromises the uniformity of that federal directive must be carefully scrutinized.

When undertaking preemption analysis, courts may evaluate whether the aim of the state law is to affect an area of federal regulation or interest. For instance, in Natsios, the First Circuit was unmoved by Massachusetts' claim that its law restricting trade with Burma was an exercise of its state procurement authority, a traditional area of state power, when the state law was "aimed primarily at effecting change in and expressing disapproval of the current regime in Burma." 181 F.3d at 74; see also N.H. Motor Transport Ass'n, 301 F.Supp.2d at 44 (evaluating whether a Maine tobacco delivery law was a "disguised attempt to impose state regulations on interstate trucking.").

IV. Application of the Governing Law

The Plaintiffs have not argued that the FDCA expressly preempts state law, but focus instead on whether the MPA Amendments are preempted under field preemption and conflict preemption principles. The Court begins with the Plaintiffs' contention that the MPA Amendments violate the Supremacy Clause under the theory of field preemption.

A. Defining the Field

In order to decide whether Congress intended to occupy the field, it is important, first, to define the field.7 The Plaintiffs assert that the relevant field is the importation of prescription drugs into the United States. The State counters that the relevant field is limited to the regulation and licensure of pharmacies and pharmacists, an area traditionally reserved for the states.

Pharmacist licensure does indeed implicate the traditionally local sphere of public health and safety. Maine, like other states, has a Board of Pharmacy responsible for regulating the licensure of pharmacies and pharmacists. See 32 M.R.S. § 13711. The FDCA does not regulate the licensure of pharmacists; it instead leaves that area to individual states. See, e.g., 21 U.S.C. § 360(g) (referencing "pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy."); 21 U.S.C. § 384(a)(2) (defining "pharmacist" as "a person licensed by a State to practice pharmacy."). If the MPA Amendments were truly limited to the regulation of pharmacy licensure, then evidence of "a congressional decision to foreclose any state regulation in the area" would be lacking. Arizona, 132 S.Ct. at 2502.

But by its plain language, the MPA Amendments extend beyond the regulation and licensure of pharmacies and pharmacists within Maine. The MPA Amendments do not, as the State asserts, simply repeal state licensure regulations; the MPA Amendments select five countries whose licensed retail pharmacies "may export" prescription drugs to Maine residents. See 32 M.R.S. § 13731(1)(B). Unlike the local blood plasma donation law in Hillsborough County, the MPA Amendments extend beyond the traditionally local arena of public health and safety and into the traditionally federal spheres of foreign commerce and affairs. See id. The existence of a state interest does not preclude a finding that the field is within the traditional federal sphere of foreign commerce. See Natsios, 181 F.3d at 74.

The legislative history of the MPA Amendments indicates that their purpose was to allow the importation of pharmaceuticals from pharmacies abroad. The Act's title — "An Act To Facilitate the Personal Importation of Prescription Drugs from International Mail Order Prescription Pharmacies" — further supports this interpretation of the State's aim. The MPA Amendments did not merely repeal pharmacy licensure laws. Instead, they were the State's attempt to enable importation of certain cheaper foreign pharmaceuticals.

The Court agrees with the Plaintiffs that, properly defined, the field at issue here is the importation of foreign pharmaceuticals. The question, then, is whether the FDCA forecloses the State's foray into the realm of pharmaceutical importation. "[W]hether the regulation of an entire field has been reserved by the Federal Government is, essentially, a question of ascertaining the intent underlying the federal scheme." Hillsborough Cnty., Fla., 471 U.S. at 714, 105 S.Ct. 2371.

B. Purpose and Structure of the FDCA

As the Supreme Court has observed, "Congress enacted the FDCA to bolster consumer protection against harmful products." Wyeth, 555 U.S. at 574, 129 S.Ct. 1187. In furtherance of this purpose, Congress has created a complex regulatory scheme covering the importation of pharmaceuticals into the United States. The FDCA prohibits the importation or introduction into interstate commerce of any "new drug" that has not received FDA approval. See 21 U.S.C. § 355. "New drug applications" require a variety of information, including information on the drug manufacturer, the drug's packaging, and how the drug will be labeled. See 21 U.S.C. § 355(b)(1). As such, even if a foreign drug is chemically identical to its domestic counterpart, it is still "unapproved" — and thus cannot be imported legally — unless it is manufactured, packaged, and labeled according to the specifications in its new drug application. See United States v. 1500 90-Tablet Bottles, 384 F.Supp.2d 1205, 1218 (N.D.Ill. 2005).

Congress has also legislated explicitly with respect to the importation of drugs from Canada. As discussed above, even though the relevant section has not taken effect, the MMA does provide a path to legally permissible importation. See 21 U.S.C. § 384. As the Eighth Circuit has reasoned:

In re Canadian Import Antitrust Litig., 470 F.3d 785, 790 (8th Cir.2006). The importation contemplated, but not yet allowed, under the MMA, together with the complex regulatory system established by the FDCA's drug approval, labeling, and packaging provisions, demonstrate a clear Congressional intent to tightly control prescription drug importation.9 Based on the foregoing, the Court concludes that the FDCA occupies the field of importation of pharmaceuticals from foreign countries.

The MPA Amendments' singling out of certain countries from which pharmaceuticals may be imported compromises the tightly regulated structure set up by the FDCA and the federal government's ability to "speak with one voice" when it regulates foreign commerce. Japan Line, 441 U.S. at 449, 99 S.Ct. 1813.

The State's arguments do not convince the Court otherwise. The State argues that it has no obligation to regulate in order to further the policies underlying the FDCA, because it is inconsistent with the Tenth Amendment for the federal government to "compel the States to enact or administer a federal regulatory program." New York v. United States, 505 U.S. 144, 188, 112 S.Ct. 2408, 120 L.Ed.2d 120 (1992); see also Printz, 521 U.S. at 933, 117 S.Ct. 2365. However, this Tenth Amendment principle cannot save a state law that obstructs federal law. Printz, 521 U.S. at 913, 117 S.Ct. 2365. To use the Plaintiffs' example, if the federal government bans coffee for health reasons, the federal government cannot insist that the states follow suit by also banning coffee. But, states may not authorize the purchase of foreign coffee if the federal government institutes an embargo prohibiting its importation. See Pls.' Combined Reply in Supp. of Mot. for J. on the Pleadings & Opp'n to Defs.' Cross-Mot. for J. on the Pleadings 3 (ECF No. 59). Federal law may preempt state law even where the federal government may not compel a state government to enact or administer a federal legislative or regulatory scheme. See Printz, 521 U.S. at 913, 117 S.Ct. 2365. The Tenth Amendment does not save the MPA Amendments from preemption.

The marijuana cases cited by the State are distinguishable as well. See Defs.' Mem. in Opp'n to Pls.' Mot. for J. on the Pleadings & Cross-Mot. for J. on the Pleadings 13, 17, 20, 21 (citing Ter Beek v. City of Wyoming, 495 Mich. 1, 846 N.W.2d 531 (2014); Qualified Patients Ass'n v. City of Anaheim, 187 Cal.App.4th 734, 115 Cal.Rptr.3d 89 (Cal.App.2010); Cnty. of San Diego v. San Diego NORML, 165 Cal.App.4th 798, 81 Cal.Rptr.3d 461 (Cal. App.2008); People v. Crouse, ___ P.3d ___, No. 12CA2298, 2013 WL 6673708 (Colo.App. Dec. 19, 2013)). None of the marijuana cases involved field preemption because Congress included a "savings clause" in the Controlled Substances Act that expressly provides that Congress did not intend to occupy the field. See 21 U.S.C. § 903 ("No provision of this subchapter shall be construed as indicating an intent on the part of Congress to occupy the field in which that provision operates, including criminal penalties, to the exclusion of any State law on the same subject matter which would otherwise be within the authority of the State, unless there is a positive conflict between that provision of this subchapter and that State law so that the two cannot stand together.").10 Accordingly, these cases are not on point.

The Plaintiffs have established that "no set of circumstances exists under which the Act would be valid." Salerno, 481 U.S. at 745, 107 S.Ct. 2095 (1987). No matter how they are applied, the MPA Amendments regulate within the field of pharmaceutical importation. The State has not suggested any limiting construction which would allow a portion of the law to stand, and the parties have not briefed the issue of severability. It is apparent that removing the portion of the statute that touches on foreign commerce would defeat the purpose of the law. Because they are contrary to clear Congressional intent to occupy the field of pharmaceutical importation, the MPA Amendments violate the Supremacy Clause and are therefore preempted.11

CONCLUSION

For the reasons stated above, the Court GRANTS the Plaintiffs' motion (ECF No. 46) with respect to Count I and declares that the FDCA preempts the MPA Amendments pursuant to the Supremacy Clause of the United States Constitution. The Court therefore DENIES the Defendants' motion (ECF No. 57). The Clerk's Office will schedule a conference of counsel to discuss what remains of this case in light of this Order.

SO ORDERED.