R.I. Rx program defies federal law

Tuesday, February 1, 2005

In a move that violates a federal ban on drug importation, Rhode Island recently initiated two programs to help residents purchase prescription drugs from pharmacies in Canada, where their cost is relatively low.

But there remain serious concerns about the safety of imported drugs, according to local and federal policymakers.

The state legislature passed a law in 2004 requiring the Department of Health to begin licensing pharmacies in Canadian provinces – just as it does pharmacies in other states. This would allow Rhode Island residents to fill their prescriptions by mail order from licensed Canadian pharmacies. Although two pharmacies in Canada have expressed interest, none have yet applied for a license, said Dr. Patricia Nolan, director of the Department of Health and a clinical assistant professor of community health.

The federal government bans the import of most prescription drugs under the Federal Food, Drug and Cosmetic Act, and Rhode Island may face legal challenges as a result of its new policy. The Food and Drug Administration sent Rhode Island Attorney General Patrick Lynch a letter on Jan. 28 warning that the state’s actions violate federal law.

But Rhode Island Secretary of State Matthew Brown did not seem concerned about federal action.

“They haven’t done anything so far” to other states with similar programs, he said. “It’s very hard to argue” against a program that cuts costs for prescription drugs.

Last week, Brown also announced a new program called RIMeds that connects residents through the Internet and phone with CanaRX, a prescription drugs wholesaler representing 60 pharmacies in Canada and the United Kingdom. Similar programs have been implemented in Illinois, Kansas, Missouri, Wisconsin and parts of Massachusetts.

Driving these actions is the rising cost of prescription drugs and insufficient insurance coverage for Americans.

“I’ve met hundreds of Rhode Islanders across the state, senior citizens especially, who can no longer afford prescription drugs,” said Brown, who added that he believes the government must “do everything we can” to help.

Canada, through its national health care plan, negotiates with drug companies for lower prices when buying drugs in bulk. U.S. health insurance companies do the same for their clients. As a result, drug prices are lower in Canada and for Americans with insurance.

But federal law, specifically the Medicare Modernization Act of 2003, forbids the government from negotiating for lower drug prices for citizens on Medicare and Medicaid, according to James Morone, professor of political science. People without any coverage must also pay full price, he said.

Morone blamed Republican ties to pharmaceutical corporations for raising costs for uninsured consumers.

“If you don’t have drug coverage – and a lot of people don’t – you’re screwed,” he said.

In the absence of federal action addressing drug prices, individual states have launched programs to help residents import cheaper drugs from Canada on the Internet. Rhode Island has gone further in allowing Canadian pharmacies the same licenses offered to out-of-state domestic pharmacies.

Nolan said that college students living in Rhode Island would be able to participate in the program.

The proposal has been met with concern regarding the safety of imported drugs. Jack Hutson, executive director of the Rhode Island Pharmacists’ Association, said “people need to look past the sound bites” at the safety issues involved, adding that there is no way to ensure the safety of imported drugs.

The Rhode Island Board of Pharmacy, which oversees licensing, criticized the program as “not being the best public policy” prior to its implementation, Nolan said. But the health department is “obligated to go forward … as the statute is actually quite instructive,” and the department will do everything it can to ensure the safety of imported drugs, she said.

Vincent Mor, chairman of the Department of Community Health, said concerns about Internet pharmacies are legitimate, but fears of Canadian pharmacies licensed by the Canadian government are less well-founded.

For Internet orders, “You don’t have a clue where that stuff’s coming from,” he said. But Canadian pharmacies are regulated by provincial authorities – just as American pharmacies are regulated by states – and most of the drugs Americans import from Canada are “exactly the same as the drugs coming into an American pharmacy,” Mor said. If the pharmacy is licensed by its province and by Rhode Island, the safety issues should be minimal, he said.

But Hutson said Health Canada, the equivalent of the Food and Drug Administration, is only mandated to regulate drugs for Canadian consumption. There is no legal oversight of drugs that might be earmarked for export to the U.S., he said, and there is no way to determine the actual source of such drugs.

He cited the ongoing case of one Internet pharmacy in Canada which kept inspectors out of its warehouse during an investigation by showing the drugs were intended for export to the U.S. and would not reach Canadian consumers.

As for the MedRI program, Brown said that the pharmacies used by CanaRX have been inspected and approved by Illinois state officials as part of their I-SaveRx program. But the first step to enrolling in the program is signing a legal liability release acknowledging “certain unavoidable risks” and agreeing that “prescription drugs purchased from other countries fall outside of the regulatory system for prescription drugs purchased in the United States,” according to the I-SaveRX program Web site.

“If it’s so safe, why would you need to sign a waiver you wouldn’t need to sign in any Rhode Island pharmacy?” Hutson said.

Nolan said drug imports from Canada are not a long-term solution to the rising cost of pharmaceuticals. She referred to the program as a “stop-gap” solution and said the federal government should address drug pricing in the longterm.

Morone said he believes Rhode Island’s actions could provoke federal action.

“I would see this as a negotiative process,” he said, adding that he believes Rhode Island’s actions will trigger one of several responses from the government. Federal policymakers may choose to fight an unpopular legal battle with the states, redefine the issue to address the problem of prescription drug pricing or “look the other way.”

“It’s easy to overlook a Web site,” Morone said. “It’s very hard to overlook what Rhode Island is doing.”

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