AUGUSTA — Several Maine pharmacy organizations have joined with a major pharmaceutical trade group to challenge the legality of a new Maine law that allows international firms to fill mail-order prescriptions.
The Maine Pharmacy Association, Retail Association of Maine, Maine Society of Health System Pharmacists, and several individual Maine pharmacists, along with national industry group Pharmaceutical Research and Manufacturers of America, filed suit Tuesday in U.S. District Court in Bangor against the ordinance, which was passed by the Maine Legislature earlier this year.
The suit names as defendants Maine Attorney General Janet Mills and state Finance Commissioner Sawin Millett.
The law has the “potential to jeopardize the safe and secure prescription medicine distribution system in the United States,” the groups said in a press release Wednesday.
The law, LD 171, lifts an August 2012 ban imposed by former Maine Attorney General William Schneider on the use of international companies to fill mail order prescriptions. Schneider determined last fall that CanaRx, a Canadian firm that cuts costs by sending medications directly to prescription holders from drug makers in Canada, the United Kingdom, New Zealand and Australia, could not be licensed as a pharmacy in Maine due to its international distribution system.
CanaRX provides mail-order pharmacy services to public-sector health plans in Illinois, Vermont, Rhode Island and other states. It supplied prescription medications since 2003 to about 900 Maine state employees, 220 employees of the city of Portland and 83 employees of the Guilford-based company Hardwood Products Co.
CanaRx shut down its MaineMeds program Aug. 15, endangering about $3 million in savings budgeted for the state employees’ health plan and creating a $200,000 budget hole for the city of Portland. Legislators concerned about resulting higher costs for medications responded with LD 171.
Now, licensed retail pharmacies in Australia, Canada, Northern Ireland, New Zealand or the United Kingdom may export prescription medicines by mail or carrier through an unlicensed middleman to Maine residents for their personal use, according to the release.
“The Maine law offers little in the way of protection for consumers,” the release states. “It does not require, for example, foreign pharmacies or importation facilitators to verify the validity or appropriateness of prescriptions being filled for individuals in the U.S.”
The legislation became law on June 27 without the signature of Gov. Paul LePage and is scheduled to take effect on Oct. 9. The suit seeks to prevent that and ultimately invalidate the law.
The groups said because foreign pharmacies are not subject to the U.S. Food and Drug Administration’s jurisdiction, American customers are not protected by “gold standard” safety regulations when they buy prescription medications from outside the country. Maine patients could potentially be exposed to counterfeit, adulterated or expired prescription medications, they said.
The law also allows patients to bypass local pharmacists, who verify prescriptions, identify potentially dangerous drug interactions and inform patients about their medications, the release states.
The groups claim the law additionally threatens Maine business interests. More than 500 licensed mail-order pharmacies are registered with the state, along with 255 retail pharmacies, Curtis Picard, executive director of the Retail Association of Maine, said in the release.
“These pharmacies comply with 43 pages of Maine statutes and 152 pages of Maine Board of Pharmacy rules — not to mention the equally stringent federal regulations,” he said. “Yet, the unregulated international pharmacies and brokers permitted under this law will escape any kind of federal or state oversight, which puts patients at risks and is bad business for everyone in Maine.”