PhRMA Statement on Court Ruling on Maine Importation Law

Pharmaceutical Research and Manufacturers of America (PhRMA) assistant general counsel, John Murphy, issued the following statement regarding a federal court ruling that invalidated an importation law in Maine.

“In September 2013, PhRMA, along with several Maine-based trade associations and individual pharmacists, filed a lawsuit against the state of Maine challenging a recently enacted law that permitted residents to personally import certain prescription medications from five countries around the globe. Our lawsuit argued that Maine’s law is preempted by the federal Food, Drug, and Cosmetics Act (FDCA) and that it interferes with the ability of the United States to speak with one voice regarding foreign commerce and the importation of prescription medications. Unfortunately, earlier in the case, PhRMA was dismissed as a plaintiff on technical standing grounds; the case, however, moved forward with all the other plaintiffs with regard to the claim that the Maine law is preempted by the FDCA.

“Last night (23 February), a federal judge in Maine agreed with our position. In short, the Court invalidated the importation law in Maine by ruling that, along with specific authority vested in the Food and Drug Administration (FDA) to regulate drug importation, the ‘FDCA’s drug approval, labeling, and packaging provisions demonstrate a clear Congressional intent to tightly control prescription drug importation,’ and that Maine’s ‘singling out of certain countries from which pharmaceuticals may be imported compromises the tightly regulated structure’ established by the FDCA.

“This is a significant victory for patients. It confirms the important role the FDA plays in regulating the drug supply chain and protecting consumers from counterfeit and adulterated medicines that may be inserted into an unregulated supply chain like the one Maine sought to facilitate.”