AUGUSTA, Maine — 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 against the state Tuesday in U.S. District Court in Bangor over the law.
The suit names as defendants Maine Attorney General Janet Mills and state Finance Commissioner Sawin Millett.
The law, passed by the Maine Legislature earlier this year, 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, which frees pharmacies in several countries from getting licensed in Maine as long as they meet their own country’s statutory and regulatory requirements.
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 and is scheduled to take effect on Oct. 9. The suit seeks to prevent that and ultimately invalidate the law.
The complaint states that 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 lawsuit presents no evidence that Maine patients have been harmed by such drugs, but notes that the FDA has documented many instances of counterfeit and harmful drugs being shipped from Canada into the U.S.
In 2003, the FDA issued a warning letter to CanaRx about supplying prescription drugs from unregulated sources and making misleading assurances to consumers about the safety of its drugs, said Kenneth McCall, president of the Maine Pharmacy Association. The letter also notes that CanaRX is not a licensed pharmacy in Canada subject to regulatory oversight.
A 2005 FDA investigation found that most drugs ordered from purportedly “Canadian” pharmacies originated in other countries, McCall said. A number of the drugs sampled were determined to be counterfeit.
Sen. Troy Jackson, D-Allagash, a primary sponsor of the law, responded Wednesday afternoon to news of the suit by calling on LePage to defend the legislation and its goal of providing access to safe, affordable prescription drugs. In a letter, he urged the governor to ask Attorney General Mills to seek to have the lawsuit immediately dismissed.
“Big drug companies with deep pockets will use any means necessary to charge high prices,” he said in a statement. “All this lawsuit is about is how much profit drug companies can grab from seniors, families and anyone needing affordable medicine.”
Prescriptions supplied by CanaRx cost up to 80 percent less than retail prices in Maine and elsewhere, he said. Canada, the United Kingdom, Australia and New Zealand have the same level of safety regulations, testing and precautions as the United States, said Jackson, who is running for the second congressional district seat now held by Democrat Mike Michaud.
LePage had not responded to Jackson’s comments by late Wednesday.
The pharmacy groups also argued that the law allows patients to bypass local pharmacists, who verify prescriptions, identify potentially dangerous drug interactions and inform patients about their medications.
In the 23-page complaint, 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, which abide by state and federal laws, Curtis Picard, executive director of the Retail Association of Maine, said in the release.