The state Department of Health has approved regulations allowing Canadian pharmacies to get licensed to sell to Rhode Island residents, despite a federal ban on drug importation and strong opposition from the Food and Drug Administration.
The regulations, filed Dec. 30 at the secretary of state’s office, will become effective in 20 days, making Rhode Island the first state to allow the licensure of Canadian pharmacies.
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Other states have taken different approaches: Illinois set up a Web site, I-SaveRx, that allows consumers to buy specific drugs from 45 locally licensed pharmacies and wholesalers in Canada, Ireland and the United Kingdom that belong to a network called CanaRx.
Wisconsin, Missouri and Kansas have since joined I-SaveRx as well. In addition, Wisconsin has a Web site that connects consumers with three Canadian pharmacies that have been inspected by state officials, but are only licensed by their local authorities.
Rhode Island Secretary of State Matthew Brown has been urging Gov. Donald L. Carcieri to join I-SaveRx, too, with no success. But despite local health officials’ reluctance to jump on the Canadian pharmacy bandwagon, the General Assembly approved a bill requiring them to provide for the licensure of Canadian pharmacies by Jan. 15.
Carcieri allowed the bill to become law without his signature, and last week, his spokesman Jeff Neal said the reason the governor didn’t want to join I-SaveRx was that he wanted to give Rhode Island’s “unique” and “cutting-edge” approach a chance.
The process of implementing the law put the Department of Health in the crossfire between importation supporters – primarily consumer advocates and senior citizens’ groups, but also Brown and the Rhode Island Medical Society – and opponents led by the Pharmaceutical Research and Manufacturers of America (PhRMA) and local pharmacists.
Opponents questioned the safety of importing drugs, arguing that without the FDA’s oversight, consumers could find themselves exposed to unsafe and counterfeit drugs. They noted that Canadian officials increasingly oppose Americans’ dipping into their drug supplies, and warned that legitimate Canadian pharmacies might back out of the U.S. market and leave only unscrupulous vendors who might ship drugs from questionable countries.
Pharmacists also spoke of the education and support they provide to consumers in a face-to-face environment, which Web sites can’t provide. And drugs from Canada, they said, might not come in the right doses, or with the proper labels and information.
Importation supporters dismissed the safety talk as scare tactics, noting that Canada has a good and well-regulated health system. Dr. K. Nicholas Tsiongas, of the Medical Society, said there is “no evidence” of safety problems with Canadian imports, and throngs of senior citizens testified that what’s really unsafe is to charge so much for drugs that people like them can’t afford, or have to choose between medicines and food.
But one after another, advocates also made it clear that they don’t really want to have to buy drugs in Canada. “This is a grassroots movement to drive the prices down,” said Bernadette Mernin, of the group Senior Agenda, at the final public hearing, Dec. 30.
After considering various options, health officials decided the best way to license Canadian pharmacies was to treat them the same as out-of-state pharmacies, so they just added “or province of Canada” to the one-page section on “nonresident pharmacies.”
In an introduction to the proposed revision handed out at the Dec. 30 hearing, health officials explained that “in response to safety concerns raised by interested parties,” they had “considered more extensive and detailed requirements” for Canadian pharmacies, but ultimately chosen to treat them the same as out-of-staters.
“The statute and regulations that govern the licensure of out-of-state pharmacies have been tested and found sufficient to protect Rhode Islanders from substandard pharmacy practice,” they wrote.
“We believe the same provisions will be sufficient for addressing safety concerns if the licensee is in Canada.”
Pharmacy industry and retail representatives made one last attempt to stop the regulations from being approved, noting that, as written, they said nothing about drugs having to be FDA-approved, or about sellers certifying the country where the drugs were manufactured, or even about the language in which usage directions should be printed – all issues that don’t arise with, say, a pharmacy in Maine.
R. Daniel Prentiss, a local lawyer for PhRMA, urged officials to adopt an alternate text that he proposed, with far-more detailed safety provisions – including a requirement that all drugs sold be FDA-approved and “accompanied by an FDA-compliant pedigree.” Prentiss acknowledged that his version could not be implemented without a change in federal policy, but he also argued that Rhode Island shouldn’t put itself at odds with the FDA.
In an interview, Assistant Health Director Robert J. Marshall said the regulations, as approved, were a first step, to comply with the law, but “this is not the end of the process. We intend to work with all the parties about the safety issues.”
Marshall also noted that neither Rhode Island’s law nor the new regulations change the fact that there’s a ban on drug importation.
“Somewhere along the line, the federal law issue needs to be resolved one way or the other,” he said. Rhode Island is “out in front on this initiative,” he added, “so I think it would pose a new situation for the federal government. We’ll have to see what they do as a result.”
