BANGOR, Maine (CN) – Maine enacted a law to make it easier for residents to buy prescription drugs from neighboring Canada, and the pharmacy and pharmaceutical industry responded with a lawsuit calling it unconstitutional.
The industry claims Maine’s “Importation Law,” approved in June and set to take effect Oct. 9, poses “serious health risks to consumers” and violates the Foreign Commerce Clause and the Supremacy Clause.
The plaintiffs scrupulously avoid the word “profits” in the 27-page federal lawsuit.
Lead plaintiff Charles Ouellette is the owner-operator of a pharmacy in Fort Kent.
Joining as plaintiffs are the Maine Pharmacy Association, the Maine Society of Health-System Pharmacists, the Retail Association of Maine, the Pharmaceutical Research and Manufacturers of America, and Amelia Arnold, a pharmacist in Augusta.
They sued Attorney General Janet Mills and Maine’s Commissioner of Administrative & Financial Services.
The lawsuit states: “The State of Maine has enacted a law (‘the importation law’) that expressly authorizes foreign pharmaceutical vendors to exports prescription drugs into the United States, circumventing the carefully-constructed closed federal regulatory structure governing prescription drugs and thus posing serious health risks to consumers. This attempt to circumvent federal law is no accident: Maine’s importation law was enacted with the avowed purpose of opening the state’s borders to foreign pharmacies, after previous iterations of drug importation programs operating in the state ended in the wake of the state attorney general’s declaration of their illegality.
“Prescription drugs shipped into Maine by foreign pharmacies pursuant to the importation law are not subject to any of the quality and safety controls put in place by the federal government in order to protect persons who rely on prescription medications. The importation law therefore puts Maine residents at risk of serious harm.
“The importation law conflicts with the considered judgment of the federal government concerning the importation of foreign drugs, poses an obstacle to the federal government’s ability to achieve the goals of its prescription drug regulatory regime, and is an invalid attempt at legislating in a field totally occupied by the federal government. Moreover, the importation law is an encroachment by the State of Maine of the federal government’s exclusive power to regulate foreign commerce.”
Until the bill takes effect, only professionals licensed under the Maine Pharmacy Act and licensed pharmacies in the state are allowed to dispense and administer prescription drugs to patients in Maine.
Under the new law, licensed retail pharmacies in Canada, Australia, New Zealand or the United Kingdom may export prescription medicines by mail or carrier through an unlicensed middleman to Maine residents for personal use.
The industry claims that federal law bans the importation of drugs that have not been approved by the Food and Drug Administration and labeled according to its regulations.
Because foreign pharmacies are not subject to the same laws, Maine customers face safety risks from foreign drugs, including risk of receiving counterfeit, misbranded, expired or adulterated drugs, the groups claim.
They say the FDA has repeatedly warned states against importing foreign pharmaceuticals, including from Canada.
“The FDA has expressed particular concerns about CanaRx, a Canadian mail-order pharmacy, regarding its illegal importation of pharmaceuticals,” according to the lawsuit. Citing a statement an FDA official made to the Senate’s Permanent Subcommittee on Investigation, the groups say: “(T)he FDA has concluded CanaRx’s illegal shipments of prescription drugs into the U.S. ‘expos[es] U.S. consumers to risky imported drug products’ and that ‘[t]his potential risk is compounded by the fact that CanaRx makes misleading assurances to consumers about the safety of its drugs.’ … The agency also avers that it ‘has evidence demonstrating that CanaRx shipped insulin, a product that should be stored under refrigeration, in a manner that did not satisfy the storage conditions specified in FDA approved labeling, and which could potentially compromise the safety and effectiveness of the insulin.'” (Citation omitted.)
Other states that have tried foreign pharmaceutical importation ended their programs after criticism that the imported drugs were not subject to monitoring by state health authorities, according to the complaint.
The plaintiffs claim that patients run additional risks because foreign pharmacies and brokers, unlike Maine licensed pharmacies, are not required to identify the prescribing practitioner, to maintain records of each patient’s health and drug history, and to check for contraindications and drug interactions.
They claim the law will shift business from regulated domestic pharmacies to unreliable foreign mail-order suppliers, and will damage the reputation and brands of U.S. manufacturers if patients receive counterfeit or expired drugs.
“Our key concerns are safety and the lack of privacy for patients,” Kenneth McCall, president of the Maine Pharmacy Association, told Courthouse News in an interview.
“According to the FDA, up to 69 percent of the drugs shipped into the United States are unsafe. Those include counterfeit medicines, controlled substances, drugs withdrawn from the U.S. market for various issues, and addictive substances,” McCall said.
He added that foreign pharmacies and brokers are not required to comply with HIPPA regulations, like U.S. healthcare providers, and are free to sell patients’ data.
The Maine Pharmacy Association, founded in 1867, has 390 members, including pharmacists, pharmacy technicians, and pharmacy interns.
The Pharmaceutical Research and Manufacturers of America, a national industry group representing pharmaceutical research and biotechnology companies that produce brand-name prescription drugs, did not return requests for comment.
The groups want the state enjoined from enforcing the law.
They are represented by David McConnell with Perkins Thompson of Portland.
The attorney general’s office issued the following statement: “The new state law addresses the problem raised by the letter of former AG Bill Schneider to Joe Bruno and other members of the Pharmacy Board a year ago, saying that an agency would need to be licensed under the then existing state law. The new law simply removes the state licensing requirement. The law is permissive not restrictive. There is nothing in this act which violates any other laws and we believe that there are no grounds for the court to enjoin the law.”
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