From Pharmalot Blog-October 09, 2013 As Maine’s Drug Importation Law Goes Into Effect, State Seeks Dismissal of Lawsuit to Block Implementation 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.

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