Two Canadian pharmacies have applied for licenses to sell prescription drugs in Rhode Island, and about a dozen have expressed interest but not yet followed up, according to Robert J. Marshall, associate director of the Department of Health.
Separately, Secretary of State Matt Brown on Jan. 27 launched RIMeds, a new drug importation service run by CanaRX, the same network of Canadian and British pharmacies behind the Illinois governor’s I-SaveRx, now used by Wisconsin, Kansas and Missouri, too.
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The RIMeds toll-free number, 1-800-656-MEDS, is already operating, but customers won’t be able to enroll until Feb. 8, with prescriptions to be filled starting Feb. 14.
Importing drugs from Canada is illegal, but widespread on an individual consumer basis. So while RIMeds fits into a trend that the U.S. Food and Drug Administration and the pharmaceutical industry have condemned, it’s the potential for licensure that’s put Rhode Island at the heart of the importation controversy.
On Jan. 28, the FDA sent a letter to state Atty. Gen. Patrick C. Lynch saying it was “very concerned about the safety risks” associated with importation, and outlining the many ways in which importing drugs would violate federal laws and FDA regulations.
“In our experience, many drugs obtained from foreign sources that purport and appear to be the same as U.S. approved prescription drugs have been of unknown origin and quality,” FDA associate commissioner William K. Hubbard wrote. “We cannot provide adequate assurance to the American public that the drug products delivered to consumers in the United States from foreign countries are the same products approved by FDA.”
As an example, Hubbard cited an American consumer’s recent purchase of Neurontin, an FDA-approved seizure medication, from a Web site that purported to be in Canada, but actually shipped drugs from India, made in India. Another consumer bought insulin that had not been refrigerated properly, Hubbard wrote, and thus might not be safe.
“Virtually all” drugs imported from Canada would violate FDA rules in some way, Hubbard wrote, and it’s a felony to reimport U.S.-made goods unless you’re the manufacturer.
“Practically speaking, it is extremely unlikely that all of the applicable legal requirements will be met if Canadian pharmacies ship drugs into Rhode Island,” Hubbard added, warning that there are “many sources of civil and criminal liability” for violators.
The letter was clearly meant as a deterrent, but Lynch, whose involvement in the importation debate had been limited so far to expressing some legal concerns, was instead emboldened to support Rhode Island’s initiative – as long as tighter safety measures are put in place.
In a letter hand-delivered to Governor Donald L. Carcieri, Lynch noted that Hubbard had specifically not said “that the issuance of a license by your Health Department violates any federal authority,” and that Hubbard had said FDA enforcement so far has focused on “those who commercialize the practice” of importing drugs.
“Because both the State of Rhode Island and the FDA share the paramount concern that our citizens obtain safe medications, it is crucial that the Department of Health address these safety issues before, or simultaneous with, the issuance of any Canadian licenses,” Lynch wrote. “This will ensure that the federal government allows our innovative legislation to go forward – as it does the bus trips that are so similar and, by now, so familiar.”
The regulations allowing Canadian pharmacies to be licensed don’t include any safety provisions beyond what is in place for U.S. pharmacies. Instead, health officials just added “or province of Canada” to the one-page section on “nonresident pharmacies.”
Lynch urged Carcieri to meet with him to discuss what additional safety measures should be taken, suggesting that he also invite key state officials, including Health Director Patricia Nolan and Susan DelMonico, chair of the Board of Pharmacy.
Asked about Lynch’s letter, Marshall said the Department of Health had every intention of continuing to perfect the licensure system for Canadian pharmacies. Nolan had held off to see if applications actually came in, he added, but she does plan to “set up some meetings with key people” who had voiced safety concerns.
“I think what the department has in mind is to get more specifics from people about what their specific concerns are with safety – not just broad, sweeping concerns,” Marshall said.
The two applications filed so far came from pharmacies in Calgary and Vancouver, Marshall said. Neither is complete yet, he said, so health officials are working on getting the missing paperwork before they begin the review process.
The full text of the FDA letter is posted on PharmaLive.com.
