A coalition representing the pharmaceutical industry in Maine has sued the state over a new law that allows consumers to buy mail-order prescription drugs from unlicensed international firms.
The Maine Pharmacy Association, the Retail Association of Maine, the Maine Society of Health System Pharmacists, the Pharmaceutical Research and Manufacturers of America and several individual pharmacists filed the lawsuit late Tuesday in U.S. District Court.
Named as defendants are Maine Attorney General Janet Mills and state Finance Commissioner Sawin Millett.
The 23-page complaint alleges that the law — which passed in June and is scheduled to take effect Oct. 9 — was a deliberate attempt to circumvent federal law and could threaten patient safety. And while the law was meant to help just one company, CanaRx, it could open the door for others.
“(The 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,” the suit states. “Prescription drugs shipped to Maine by foreign pharmacies pursuant to the (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 (law) therefore puts Maine residents at risk of serious harm.”
In 2012, former Attorney General William Schneider determined that CanaRx, an international firm that had been providing low-cost medication since 2003 to more than 1,000 Mainers, could not be licensed as a pharmacy in Maine.
His decision prompted CanaRx to halt its MaineMeds program, which had been offered to employees of state government, the city of Portland and Hardwood Products of Guilford. Ending the program threatened nearly $3 million in savings under the Maine state employees’ health plan and another $200,000 in savings for the city of Portland.
Lawmakers stepped in and drafted a bill — LD 171 — that was designed to allow CanaRx to continue doing business in Maine. The bill was opposed by the same groups who filed Tuesday’s lawsuit, but still passed easily in the House and Senate. Gov. Paul LePage had initially indicated support for an early proposal, but the bill became law without his signature.
Timothy Feeley, spokesman for the Attorney General’s Office, said the law addressed the problem raised by Schneider’s 2012 decision.
“The new law simply removes the state licensing requirement. The law is permissive, not restrictive,” he said. “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.”
As enacted, the new law would allow a licensed retail pharmacy in Australia, Canada, Northern Ireland, New Zealand or the United Kingdom to export prescription medication by mail through an unlicensed entity to residents in Maine for personal use. Those pharmacies do not need to have a Maine license as long as they meet their own country’s statutory and regulatory requirements.
The law allows CanaRx to resume business, but it also paves the way for other international companies to do what CanaRx has done.
Senate Majority Leader Troy Jackson, D-Allagash, who sponsored the bill that became law, said the lawsuit is baseless and should be dismissed.
“I sponsored legislation to restore access to safe, affordable, life-saving prescription drugs. My bill passed earlier this year and became Maine law with the support of a majority of Maine legislators,” he said in a written statement. “We had a successful, tested, open lifeline to CanaRx that was cut off by drug companies looking to charge higher and higher prices for drugs that Maine people could buy for a lot less. My bill reopened access to CanaRx and affirmed that individuals in Maine can obtain prescription drugs from the countries where CanaRx fills prescriptions.”
But Kenneth McCall, president of the Maine Pharmacy Association, said the law offers no safeguards from allowing counterfeit or expired medications and ignores the role that pharmacists play in delivering quality health care.
“In addition to identifying potential drug interactions for patients who may receive multiple prescriptions, Maine pharmacists regularly consult directly with prescribing physicians when questions arise,” he said. “Maine pharmacists also help inform patients about the medications that have been prescribed and are available to consult with patients in the event that the patient has an adverse reaction.
“This new law deprives Maine residents and Maine physicians of these critically important functions that Maine pharmacists provide.”
Additionally, the suit says, there already are more than 500 licensed mail-order pharmacies that do business with Maine and that must comply with state regulations.
The lawsuit first asks the court to grant a preliminary injunction preventing thelaw from going into effect Oct. 9. Ultimately, the coalition of pharmacists and pharmacy groups wants the law invalidated.
State officials did not respond to requests for comment.
Eric Russell can be contacted at 791-6344 or at: