By Kurt R. Karst –
We were reminded earlier today that a new law has gone into effect in the state of Maine permiting the importation of drug products into the state from licensed retail pharmacies located in certain foreign countries. As we previously reported, in September, the Pharmaceutical Research and Manufacturers of America (“PhRMA”), along with several other trade groups – the Maine Pharmacy Association, Maine Society of Health-System Pharmacists, and Retail Association of Maine – and two pharmacists, filed a Complaint and Motion for Preliminary Injunction against Maine’s Attorney General and Commissioner of Administrative & Financial Services in the U.S. District Court for the District of Maine in an effort to block implementation of the importation law. Plaintiffs allege in their filings that the Maine importation law is preempted under the Supremacy Clause of the U.S. Constitution (U.S. Const. Art. VI, cl. 2) because federal statutes, like the FDC Act and the 2003 Medicare Modernization Act (“MMA”), “occupy the field and the Maine law conflicts with and obstructs compliance with those statutes.” Plaintiffs also allege that the Maine law violates the Foreign Commerce Clause (U.S. Const. Art I, § 8 cl. 3) because it “purports to regulate in an area where the federal government possesses exclusive and plenary power.” That is, the state law violates the requirement that the federal government “speak with one voice in the area of international pharmaceutical trade” and discriminates against foreign commerce.
In recent court filings, Maine has opposed Plaintiffs’ Motion for Preliminary Injunction and has moved to dismiss the Complaint. According to those pleadings, the new state law (referred to as the “2013 Amendment”):
does not affirmatively “authorize” Maine residents to buy prescription drugs from pharmacies located in Canada or any other country, and it does not “aid and abet violations” of the [FDC Act]. Rather, the 2013 Amendment simply restricts the reach of the Maine Pharmacy Act. No constitutional provision requires Maine as a state to regulate in an area it chooses not to regulate.
Bearing that proposition in mind, Defendants say that “[t]he crux of plaintiffs’ lawsuit is the proposition that they can require a state to affirmatively regulate pharmacies in accordance with plaintiffs’ view of federal law where that state has chosen not to regulate. No court of which defendants are aware has ever adopted such an extraordinary principle.” “The 2013 Amendment is a classic example of a state acting to limit the extent of its traditional police powers – deciding not to assert its regulatory authority over certain conduct,” says Maine. “The State of Maine has every right to take such steps. To the extent that plaintiffs seek to require the State to enact laws to further the policies underlying the FDCA, plaintiffs run afoul of the Tenth Amendment.” Under the Tenth Amendment, powers not granted to the federal government by the Constitution, nor prohibited to the States, are reserved to the States or the people. “Maine is free to choose not to regulate the conduct of pharmacies located in other countries – even if those pharmacies may engage in conduct that violates the FDCA. There is no constitutional principle that requires that a state regulate pharmacies (or any other industry),” continues Maine.
Moving on to the Foreign Commerce Clause, Defendants say that Plaintiffs’ theories are meritless. “The foreign Commerce Clause is concerned with state laws that discriminate against foreign commerce or that excessively interfere with foreign affairs. . . . [P]laintiffs filed this lawsuit because they are upset that the 2013 Amendment allegedly ‘authorizes’ foreign commerce at the expense of in-state commerce. Even assuming that were true, however, the 2013 Amendment does not violate the foreign Commerce Clause” (citation omitted).
But these arguments all assume that Plaintiffs have standing to bring the lawsuit in the first place. They don’t, says Maine:
This suit should be dismissed because no plaintiff has standing to assert violations of these constitutional provisions. The 2013 Amendment, which restricts the reach of the Maine Pharmacy Act, does not directly affect plaintiffs. No plaintiff is a retail pharmacy located outside the United States, and no plaintiff alleges that it plans to provide or facilitate the export of prescription drugs into Maine from a pharmacy located outside the United States. In short, no plaintiff alleges that it has engaged or plans to engage in conduct covered by the 2013 Amendment. Plaintiffs seek to enjoin the enforcement of an amendment that does not apply to them.
Moreover, plaintiffs purportedly seek to vindicate the interests of third persons – (A) Maine residents who may decide to purchase less expensive prescription drugs for their personal use from licensed pharmacies located in such places as Canada or the United Kingdom, and (B) pharmacies located in countries other than Canada, the United Kingdom, Australia, or New Zealand. Plaintiffs’ own alleged injuries from the 2013 Amendment are indirect, remote, and speculative.
Plaintiff’s have requested that Oral Argument on the various motions in the case be scheduled for the week of November 4, 2013. The court has not yet set a hearing date.