When Maine passed a law in June 2013 allowing residents to purchase prescription medication by mail from overseas, it entered uncharted waters. The state became the first in the nation to formally defy federal regulations that prohibit Americans from importing drugs through foreign pharmacies, which often sell the same medications for half the cost.
While Maine’s law set a new national precedent, the controversial legislation unofficially sanctioned a hunt for cheaper prescription drugs that has driven Mainers across the border to Canada for years. Drug makers and Maine pharmacy groups argue in a federal lawsuit that the law could expose consumers to contaminated or phony medications and undermine federal oversight. Supporters contend the industry is more worried about protecting its profits.
Now a Bangor man finds himself at the intersection of the conflicting laws, ordered by federal officials to return medication he purchased with the state’s blessing. The U.S. Food and Drug Administration is flexing its enforcement muscle against him in an unusual move that could potentially affect other Maine consumers buying drugs from overseas.
Along for the ride is former Maine Sen. Troy Jackson, who championed the drug importation law and now works for a United Kingdom pharmacy chain that set up shop in Maine under its auspices.
Shortly after the Great British Drug Store launched in Maine in October, Chris found his medication on the online pharmacy’s website for a fraction of the cost he normally paid. His doctor sent his prescription to the pharmacy’s mailing address in Portland and Chris placed his order.
Chris asked the Bangor Daily News not to publish his last name or identify the medication he purchased for privacy reasons.
A few days later, the package arrived on his doorstep, containing the first five pills, with the remaining 45 to be delivered after the British pharmacy completed processing his payment. Then a representative from FedEx called, offering a confusing account about the subsequent shipment’s progress, he said. But the second package soon arrived and Chris signed for it, thinking he was well on his way to saving money on his medication.
Four days later, FedEx called again, saying the FDA had intended to detain the drugs, which were shipped to him by mistake. A representative from the agency then phoned, Chris said, explaining that as far as the federal government was concerned, his drugs were “unapproved.”
“I said ‘Maine law allows me to order these drugs,’” Chris said. “He said, ‘Take that up with the state.’”
Chris since has received multiple letters and phone calls from FedEx and the U.S. Food and Drug Administration, he said, directing him to return the medication. He has been warned he could face a $2,300 fine if customs officials demand the drugs back and he refuses, he said.
“It’s almost like a collection agency because they just keep threatening and threatening,” Chris said.
In a Nov. 24 letter from the FDA that he shared with the Bangor Daily News, the agency states that his medication is “subject to refusal” because the pills “appear to be adulterated, misbranded, or otherwise in violation” of federal law. He already had started taking the pills by that point, and said he still can’t get a straight answer from the FDA about whether the medication is counterfeited, otherwise potentially dangerous, or perfectly safe but simply in violation of federal law because he ordered it from a foreign pharmacy.
The drugs appear legitimate, shipped in the manufacturer’s sealed original packaging, Chris said. He’s still taking the pills and feels fine, he said. But he’s left without answers, even after calling the offices of the Maine attorney general and U.S. Sen. Susan Collins in search of clarity, he said.
Maine’s drug importation law took effect on Oct. 9, 2013, a year before Chris placed his order. It allows Maine residents to buy prescription drugs from Internet pharmacies in Canada, the U.K., Australia and New Zealand, which the U.S. government deems to have equivalent or greater drug safety and licensing regulations. Those countries, among others, can sell prescription drugs more cheaply because their governments cap prices or negotiate prices with drug makers.
“If we passed the law, which we did, then somebody has to stand up for the law,” Chris said.
The FDA declined to comment on Chris’ situation, saying the agency doesn’t discuss ongoing enforcement actions. But in an emailed response, the FDA acknowledged that it has refused several shipments to Great British Drug Store customers in Maine.
“In reviewing drugs for approval, FDA evaluates, among other things, whether the drugs are safe and effective and are manufactured in accordance with current good manufacturing practice,” the agency said. “The FDA has been and will continue to monitor drug imports to protect American consumers.”
While importing drugs is illegal under federal law, the agency rarely enforces the ban among consumers.
“FDA does not know the true source of drugs and who may be handling the drugs if they are obtained from suppliers that are outside of the drug supply chain for an FDA-approved drug product,” the agency wrote. “Therefore, FDA cannot ensure that the safety or effectiveness of drugs imported from unknown foreign sources is the same as products approved by FDA.”
The Great British Drug Store maintains that the drugs it supplies are just as safe as those dispensed by American pharmacies. Operated by the British pharmacy company Weldricks, an independently owned chain with 61 locations throughout the United Kingdom, the site serves only Maine consumers. All of its medications are sourced from U.K. wholesalers supplied directly by drug manufacturers, according to Mary O’Brien, managing director.
“We send drugs from a pharmacy in England that are dispensed to thousands of patients in England everyday,” she wrote in an email. “The safety standards in England are as rigorous as the FDA’s so there is no issue with the drugs.”
Packages for eight customers were delayed and a ninth person failed to pay for an order and arranged for an alternative from Canada, she said. Those nine shipments — which included asthma inhalers and medications for erectile dysfunction — represent a small portion of the several hundred orders Great British Drug Store has processed, O’Brien said.
In some cases, packages were held temporarily while federal officials confirmed the source of supply, she said. FedEx mistakenly delivered Chris’ order before federal officials completed that process, O’Brien said.
“We have hundreds of customers placing repeat orders for refills and have established contact with several doctor offices who are placing orders direct,” she wrote.
But Kenneth McCall, immediate past president of the Maine Pharmacy Association, said Maine’s law places consumers in a dilemma by conflicting with federal regulations.
“I don’t know of any other state law that’s put patients in this kind of predicament before,” he said.
The pharmacy association was among several groups that filed a lawsuit in September 2013 seeking to invalidate the law, arguing it jeopardizes the safety of the nation’s prescription drug supply and opens the door to counterfeit and tainted medications. The suit, which names as defendants Maine Attorney General Janet Mills and a former state finance commissioner, is pending in federal court.
Many online pharmacies designate their customers as the “importer of record,” leaving consumers responsible if any laws are violated, said McCall, an associate professor in the College of Pharmacy at the University of New England.
In its terms and conditions, Great British Drug Store’s website uses the same language, stating customers “should ensure that your purchase is in full compliance with the laws of the country into which the goods are being imported.”
Chris reached out to the Maine attorney general’s office but received no assistance, he said. An AG spokesman said the office wouldn’t pursue his complaint, describing it as a “private legal matter between him and the FDA.”
That worries McCall, who said other consumers could find themselves in a similar situation.
But Jackson, the former Democratic state senator from Allagash who sponsored Maine’s drug importation legislation, said one customer’s unfortunate circumstance doesn’t undermine the law overall. Jackson, a onetime Maine Senate majority leader, is now a consultant and spokesman for Great British Drug Store, which approached him about the job after the November election, he said.
“I don’t think people should feel like they’re held hostage by an industry that’s monopolizing their health … I’m very much invested in that argument and that debate. I would be regardless if I was working for this company or not,” Jackson said.
He suspects the FDA intervened in several of Great British Drug Store’s shipments to conduct spot checks because the company is a new supplier. No packages have been stopped since November, he said. Neither he nor O’Brien view the agency’s actions as part of a broader move to put its foot down over Maine’s drug importation law.
Another mail-order pharmacy, CanaRx, continues to operate in Maine. That company, a Canadian firm, was at the center of the debate over Maine’s law. It served public and private employers in Maine since 2004, but Maine’s former attorney general ruled in March 2013 that it couldn’t be licensed as a pharmacy in the state. Jackson’s law lifted the licensing requirements.
“The pharmacy industry is pushing hard to stop this because they see their cash cow possibly slipping away,” he said.
Maine’s law has put the federal government on the spot over the issue of unaffordable prescription drug prices, Jackson said.
“This is going to force the issue of prescription drugs in this country … I just don’t think it’s fair that the very same drugs that you get in this country you can get from another one at 70 percent less.”
U.S. Sen. Susan Collins said Chris’ situation highlights the need for clarity over prescription drug importation policies.
“This particular case is an example of why it’s necessary for Congress to debate this issue and to come up with a national policy that would allow consumers to safely import prescription drugs at a lower cost, while avoiding harmful or ineffective counterfeit drugs,” she said in a statement.
Jackson contacted Chris and offered to refund his order and refill the prescription. But without a clear answer on whether he’s protected under Maine law, Chris remains worried that the FDA will keep him on the hook for the medication he’s already used.
“I just want it over with now,” he said. “I’ve never gotten a good answer out of anybody.”