20 August 2004
Several states move ahead of feds on drug re-imports
Rhode Island, acting under a first-in-the-nation state law, is preparing to license Canadian pharmacies to sell prescription drugs.
Rhode Island's new law is the only one in the country that requires the licensing of Canadian pharmacies in the same way mail-order pharmacies located in the United States are licensed.
Rhode Islanders already can order drugs from Canada by phone or on the Internet, or through a storefront operation in Warwick, R.I. Their savings on brand-name drugs are said to range from 30 percent to 70 percent.
Other states have gone head-to-head with the federal government over the Canadian drugs in other ways.
Illinois this week announced plans to set up a Web site making it easy for state residents to buy 100 common drugs from Canada - and Britain and Ireland, too. Previously, Minnesota, New Hampshire, North Dakota and Wisconsin had established such Web sites for Canadian drugs only, and Rhode Island's secretary of state, Matthew Brown, has provided a link to the Minnesota site. Vermont petitioned the Food and Drug Administration to set up such a site on its own, and sued when the agency refused.
Rhode Island's new law passed the legislature with unanimous votes in both houses this year. The FDA then wrote to Gov. Donald Carcieri, pointing out that federal law supersedes state law. Nevertheless, Carcieri let the bill become law without his signature..
Now, the state Health Department, which argued against the bill, is grappling with its requirements, and the FDA is waiting to see what happens.
"I'm proceeding to develop rules and trying to figure out how to implement this statute," said Dr. Patricia A. Nolan, state health director. The law is to go into effect Jan. 15. After the licensing rules are developed, Nolan said, she will ask the FDA to review them.
And if the FDA objects to them? "We'll figure that out then," she said.
William Hubbard, the FDA's associate commissioner for policy and planning, said his agency had no immediate plans to move against Rhode Island. "There's no violation, yet, of federal law," he said.
If the state licenses a Canadian pharmacy and it begins shipping drugs, "we may have to step in," Hubbard said. "We have to cross that bridge when we get to it."
The FDA has yet to prosecute any of the state or local governments that have been helping their citizens get Canadian drugs. "We hope we never do," Hubbard said. The agency may eventually ask a judge to rule on the matter, he said.
In a news release, state Attorney General Patrick Lynch said the new law "could violate federal law" and thus "creates a legal quagmire" for the state. He said he expressed his concerns in a letter to Nolan, but Nolan said she hadn't received it.
Asked what he thought the Health Department should do, Lynch would say only that he's calling on the FDA to allow drug importation. He also said he had no plans to ask for a court to rule on the conflict between state and federal law.
Lynch said proponents of the law are too quick to dismiss the FDA's concerns about the safety of imported drugs. "You've got to remember you're dealing with drug vendors you've never seen. You don't know whether drugs are counterfeit, diluted, mislabeled, mishandled or unapproved," he said. "The only way to properly do is for the federal government to step up with changes in the law."
By Felice Freyer
The Providence Journal
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