Not In Our Backyard! Pharmacists and Trade Groups Sue to Block Implementation of Maine Drug Importation LawSeptember 12, 2013
By Kurt R. Karst –
Earlier this week, 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 in the U.S. District Court for the District of Maine against Maine’s Attorney General and Commissioner of Administrative & Financial Services in an effort to bar the state from implementing a state law that would permit the importation of drug products into the U.S. from licensed retail pharmacies located in certain foreign countries. The state law, enacted on June 27, 2013 (after Governor Paul LePage declined to sign the bill) and titled “An Act To Facilitate the Personal Importation of Prescription Drugs from International Mail Order Prescription Pharmacies,” is scheduled to go into effect on October 9, 2013.
The law is pretty short. Section one amends 32 MRSA §13731, sub-§1 to state:
1. Applicability. It is unlawful for any person to engage in the practice of pharmacy unless licensed to practice under this Act, except that:
A. Physicians, dentists, veterinarians or other practitioners of the healing arts who are licensed under the laws of this State may dispense and administer prescription drugs to their patients in the practice of their respective professions where specifically authorized to do so by law;
B. A licensed retail pharmacy that is located in Canada, the United Kingdom of Great Britain and Northern Ireland, the Commonwealth of Australia or New Zealand that meets its country's statutory and regulatory requirements may export prescription drugs by mail or carrier to a resident of this State for that resident’s personal use. A licensed retail pharmacy described in this paragraph is exempt from licensure under this Act; and
C. An entity that contracts to provide or facilitate the exportation of prescription drugs from a licensed retail pharmacy described in paragraph B may provide or facilitate the provision of prescription drugs from that pharmacy by mail or carrier to a resident of this State for that resident's personal use. An entity that provides or facilitates the provision of prescription drugs pursuant to this paragraph is exempt from licensure under this Act.
Section two adds 32 MRSA §13799:
§ 13799. Consumer choice preserved
Nothing in this chapter may be construed to prohibit:
1. Ordering or receiving prescription drugs. An individual who is a resident of the State from ordering or receiving prescription drugs for that individual’s personal use from outside the United States by mail or carrier from a licensed retail pharmacy described in section 13731, subsection 1, paragraph B or an entity described in section 13731, subsection 1, paragraph C; or
2. Dispensing or providing prescription drugs. A licensed retail pharmacy described in section 13731, subsection 1, paragraph B or an entity described in section 13731, subsection 1, paragraph C from dispensing, providing or facilitating the provision of prescription drugs from outside the United States by mail or carrier to a resident of the State for that resident's personal use.
Controversy over the importation of drugs into the U.S. is not new. As we previously discussed, the FDC Act generally prohibits importation of drugs by individuals. For example, the 1988 Prescription Drug Marketing Act amended the FDC Act to explicitly prohibit the reimportation of drugs manufactured in the U.S by individuals or entities other than manufacturers. In addition, the 2003 Medicare Prescription Drug, Improvement, and Modernization Act (“MMA”) amended the FDC Act to include provisions authorizing the creation of a system for importation of prescription drugs from Canada, upon certification of safety and cost savings. The provisions are only effective if the Secretary of Health and Human Services (who has authority over FDA) certifies safety, but that has not yet happened. In the years since, there have been numerous legislative attempts to permit importation, but each attempt has failed (see, e.g., here).
For its part, FDA has long opposed permitting individual imports of prescription drugs except under very limited conditions. The Agency has said on many occasions (here, here, and here, for example) that drugs imported for personal use “violate the FDCA because they are either unapproved new drugs[,] labeled incorrectly[,] or dispensed without a valid prescription” and can post safety risks. FDA has found support for its position on importation in court. In one case – Vermont v. Leavitt, 405 F. Supp. 2d 466 (D. Vt. 2005) – a federal court concluded that a state plan for importing drugs from Canada violated the FDC Act (see here).
According to PhRMA, et al., Maine’s drug importation law – dubbed an “unauthorized experiment” – “was enacted with the specific goal of encouraging and enabling state health insurers in Maine to direct their customers toward less expensive foreign mail-order pharmaceutical brokers, even though such foreign brokers and the products they supply are not subject to the exacting standards mandated by federal law and so pose serious health risks.” The state law, say Plaintiffs, violates federal law, and implementation of it would mean that Maine is aiding and abetting violations of federal laws prohibiting unauthorized importation of drug products.
The alleged violations are numerous. For example, Plaintiffs say that the state 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,” and that it is also preempted under the Supremacy Clause (U.S. Const. Art. VI, cl. 2) because federal statutes, like the FDC Act Act and the MMA “occupy the field and the Maine law conflicts with and obstructs compliance with those statutes.” More directly, the Plaintiffs state that the Maine law “rips a hole in the ‘closed’ pharmaceutical delivery system and thus clearly constitutes an obstacle to full and effective implementation of federal goals. Most obviously, ‘[b]ecause the [Maine] Act authorizes [foreign pharmaceutical vendors] to engage in conduct that the federal Act forbids, it stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.’”
A hearing date on the Plaintiff’s Motion for Preliminary Injunction has not yet been set. We’ll keep an eye on the court docket and keep you posted.