online Canadian pharmacies like Canadameds.com
R.I. bill would sidestep federal
law
Rhode Island lawmakers are set to consider a bill in coming weeks that could give state residents easier access to lower-priced prescription drugs from Canada.
But whether the bill would really change anything remains a question.
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The legislation essentially is intended to skirt a federal law prohibiting the “re-importation” of prescription drugs – medicines that were manufactured in the United States, exported and then shipped back into the country.
The practice of buying medications from Canada, primarily via the Internet, has grown in recent years along with soaring prescription-drug prices, because prices for some drugs in Canada are as much as 80 percent lower than in the United States. It is illegal for Canadian pharmacies to ship American-made pharmaceuticals back into the country, but regulators in most states have ignored the practice.
The Rhode Island Department of Health, through its Board of Pharmacy, is a rare exception. Last year it sent a cease-and-desist order to at least one Canadian pharmacy that was shipping pharmaceuticals to Rhode Island.
The pending House bill would require the Board of Pharmacy to grant licenses to valid Canadian pharmacies – regardless of whether or not they run afoul of federal law by shipping medications that originated in the United States.
The House Corporations Committee on April 9 approved the bill, which is sponsored by Rep. Fausto C. Anguilla, a Bristol Democrat, and backed by the Rhode Island Medical Society. As of last week, no date had been set for the full House to consider the measure.
Even if the House bill were to pass, though, regulators have said they would be hard-pressed to ignore the federal law.
“Right along, we’ve informed members of the General Assembly that the barrier is at the federal level,” said Helen Drew, the Department of Health’s legislative liaison.
Drew says the issue is not one of licensure; the state will grant licenses to any foreign pharmacy – as long as it fully complies with both state and federal law.
“If a pharmacy is re-importing, it is not in compliance,” Drew said.
But the bill’s backers say a key amendment to the House bill should diffuse that issue. It states that the “federal prohibition on importation of prescription drugs shall not be the basis for denying licensure to a Canadian pharmacy.”
In other words: ignore the federal government.
“We don’t think the Department of Health should be in the business of enforcing a law that the feds themselves aren’t interested in enforcing,” said Dr. Nick Tsiongas, a former state legislator and a member of the Rhode Island Medical Society’s executive committee.
The society claims that Rhode Island is one of only three states that has moved to enforce the federal ban on re-importation of prescription drugs, even while the FDA largely has turned a blind eye to the practice.
But there are signs that the administration’s stance on the re-importation issue might be hardening. In March, the U.S. Food & Drug Administration sent a cease-and-desist order to Rx Depot, an Arkansas pharmacy that imports drugs from Canada, according to an April 7 report in Drug Store News, a trade journal.
“Rx Depot and similar companies often state incorrectly to consumers that the FDA condones their activities,” the FDA’s order reportedly stated. “In all states, it is a violation to sell prescription drugs in the state without proper licensing by the state.”
And FDA officials last month said they have begun discussions on the re-importing issue with Canada’s drug regulatory body, Health Canada, according to the Financial Times.
Carmen A Catizone, executive director of the National Association of Boards of Pharmacy, said the Rhode Island bill would put the state’s Board of Pharmacy in the awkward position of having to choose between complying with state or federal law.
“This would require the state board to license entities that are operating illegally,” Catizone said. He added that he has not seen any state legislation similar to Rhode Island’s, although there have been “rumblings” of similar measures in other states, particularly among Northeast states, he said.
In a March 12 letter to Catherine A. Cordy, chief of the Rhode Island Board of Pharmacy, Catizone said the proposed House legislation raises safety concerns.
“Allowing the practice of cross-border Internet trade of medicines to continue and expand opens up the U.S. population to those who would take full advantage of the lack of regulatory enforcement,” the letter reads.
The bill’s supporters, however, say safety is not an issue, because most of the drugs in question were manufactured in United States at FDA-approved facilities.
Meanwhile, many patients struggle to pay for prescription drugs as prices continue to climb, the medical society says.
“There are a lot of patients who need medicines and can’t afford it,” said Steven R. DeToy, a society spokesman. “This bill would give them access to less expensive medicines, and that’s good for everybody.”
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