With so many of our respected friends and colleagues furloughed, federal agency budgets decimated, or wholly dependent on user fees to operate, and so much important business on hold due to the intransigent federal budget showdown, it’s not surprising that the States have stepped up to fill the vacuum. One example is the State of Maine. Yesterday, Governor LePage declared a civil emergency and L.D. 171, Maine’s Act to Facilitate the Personal Importation of Prescription Drugs From International Mail Order Pharmacies, went into effect. As of October 9, 2013, licensed retail pharmacies located in Canada, the United Kingdom, Northern Ireland, Australia, or New Zealand may now export prescription drugs to Maine for residents’ personal use. Further, any entity that contracts to provide or facilitate this export is exempt from the state licensure required of other pharmacies and entities under the Maine Pharmacy Act.
L.D. 171 was introduced in the Maine legislature on the belief that making it possible for Maine residents to mail order prescription drugs from foreign pharmacies could reduce health care costs (see here and here). It passed the Maine legislature in June 2013, though Governor LePage declined to sign it. L.D. 171 became law on June 27, 2013, and became effective 90 days after the close of the legislative session. (Text and disposition of the law are here.)
Not surprisingly, retail pharmacy and pharmaceutical company stakeholders vigorously opposed L.D. 171 and, just last month, they sued the State in federal district court to stop it. You can read the full Complaint and their motion for a preliminary injunction.
Plaintiffs argue that the Maine law violates the Foreign Commerce Clause of the U.S. Constitution (Art. I, § 8, cl. 3), which mandates that the U.S. federal government act as one voice in foreign trade and forbids state interference. They further assert that the federal Food, Drug and Cosmetic (FDC) Act and FDA’s implementing regulations create a “comprehensive framework” that prohibits the importation of unapproved drugs into the U.S. If that sounds like a preemption argument to your sensitive ears, you’re correct. Plaintiffs claim the Maine law directly conflicts with federal prohibitions on importation of unapproved drugs in the FDC Act and the Medicaid Prescription Drug, Improvement and Modernization Act (MMA). They further argue “field preemption” – that the FDC Act and MMA were intended to “occupy the field of pharmaceutical importation” without leaving any room for state legislative activity. Plaintiff’s Motion for Preliminary Injunction at 18-22.
The State of Maine both responded to the plaintiffs’ prayer for injunctive relief and filed a separate motion to dismiss the Complaint in its entirety. The State counters that it is simply declining to enforce its own laws as to certain foreign pharmacies that choose to sell to Maine residents. Further, the State continues, plaintiffs do not have standing to challenge L.D. 171 because the law does not apply to them.
The parties jointly asked for oral argument the week of November 4. Today, the Wall Street Journal is reporting mixed reactions by Maine employers. The Maine State Employees Association is waiting until the lawsuit is resolved before it begins ordering drugs through CanaRx, a Canadian prescription drug supplier. Others, such as the City of Portland and Hardwood Products, are planning to take advantage of the law immediately. Outlets have reached out to FDA for comment on whether it will step into the fray – unfortunately, given the government shut down, no one has been able to respond.
Bienvenue Aux Etats-Unis!
