Almost four months after the state Department of Health approved regulations allowing Canadian pharmacies to get licensed to do business in Rhode Island, all three applications filed so far are stalled, and officials are considering major revisions to protect consumers.
Don Williams, associate director for health services regulation, said the department had acted after being “admonished” by Attorney General Patrick C. Lynch – who had been contacted by the U.S. Food and Drug Administration – for not doing enough to protect the safety of Rhode Islanders.
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“So we’re trying to establish greater safeguards,” Williams said. “Unfortunately that is a very difficult task.” The entire drug safety system in the United States “is predicated upon a strong role by the FDA,” Williams added, and with Canadian drugs, “in essence we’ve got to create a substitute for the FDA, arguably, with comparable safety provisions.”
The department took its first public step toward revising the importation rules on April 14, at a hearing to which Williams said all interested parties were invited, but only representatives of the pharmaceutical industry and retail pharmacies actually attended.
Both groups strongly oppose drug importation, and they quickly seized the opportunity to bolster their arguments with a new industry-paid study by former New York Mayor Rudolph Giuliani on the dangers of Canadian drugs and with testimony from two concerned Canadian leaders: Marc Kealey, CEO of the Ontario Pharmacists Association, and Chris Ward, a former member of the Ontario Parliament and parliamentary assistant to the minister of health.
The Giuliani report, commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA), warns that importation could pose a “serious risk” to the nation’s drug supply, and recommends halting efforts such as Rhode Island’s, but it also says many of the dangers are present even without legal importation.
“Unapproved drugs have already compromised the system,” Giuliani wrote. “Non-FDA approved drugs are already getting into the United States, as evidenced by inspections at various airport mail facilities. Random inspections found that 86 percent to 88 percent of the suspected drug parcels examined contained non-FDA approved medicines from such countries as Pakistan, Mexico, Brazil, the Netherlands and Canada.”
Giuliani also noted that the World Health Organization, the FDA and pharmaceutical companies already report a rise in counterfeit drug cases. And in a passage that industry leaders touted most loudly, Giuliani said importation could make America more vulnerable to terrorists.
“The present system of importation, inspection and distribution is vulnerable to exploitation and abuse by drug traffickers, organized criminals and terrorists,” Giuliani wrote. “Several credible sources have identified links between counterfeit goods, including pharmaceuticals, and organized criminals and terrorist groups. Based upon what was learned about the existing system, it is not difficult to imagine a scenario in which terrorist groups could use this system to either finance their operations or, worse, as a vehicle of attack.”
In a news release from R.I. Safe Meds, Kealey is quoted pointing to Giuliani’s report as evidence of the “dangers of importation,” and calling Rhode Island’s regulations “seriously flawed and in direct conflict with Canadian law on several critical points.”
Health officials did take a minimalist approach to the task, mandated by a law passed last year, of approving regulations for licensing Canadian pharmacies. While other states and cities importing Canadian drugs have various safety measures in place, the Rhode Island Department of Health opted to apply the same regulations to Canadian pharmacies as it does to out-of-state entities.
Because U.S. pharmacies, by definition, can only sell FDA-approved drugs, the rules don’t include any such requirement, for example. Nor do they say anything about drug instructions having to be in English, or drugs’ country of origin being documented.
PhRMA lobbyists and the Rhode Island Pharmacists Association tried to persuade health officials that without more safeguards, the regulations would be fatally flawed. As an alternative, they encouraged the Department of Health to pass regulations that would allow Canadian pharmacies to be licensed to sell drugs in Rhode Island if they’re approved by the FDA.
Given that the FDA refuses to get involved in reimportation, and continues to warn those engaged in the practice that it’s illegal, the regulations would effectively prevent Canadian pharmacies from being licensed while technically complying with the new state law.
In an interview, Williams said the department is looking at other ways to protect consumers, but the PhRMA suggestion is “starting to look more attractive.” It’s not what the department set out to do when it reopened the regulation-drafting process, he said, but “it’s on the table.”
As for Giuliani’s report, Williams said: “I haven’t seen it. It doesn’t really matter. It’s irrelevant. PhRMA paid for it.” But he does agree with its basic point: legalizing the importation of drugs from Canada “was a bad idea.”
