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Pharmaceutical Group Challenges Maine's Drug Importation Law
09/11/2013   Reported By: Susan Sharon

A group of Maine pharmacy organizations is challenging the legality of Maine's  new drug importation law. The group, which includes individual pharmacists and the Pharmaceutical Research and Manufacturers of America, is asking a federal judge to prevent the law from taking effect Oct. 9.  At issue are concerns the law could jeopardize patient safety.  Susan Sharon reports.

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In a lawsuit filed in U.S. District Court in Portland, the pharmacy group claims that the importation law circumvents federal regulations governing prescription drugs, and could pose serious health risks to consumers.

The law allows consumers to purchase lower-cost prescripton drugs by mail from licensed pharmacies in Australia, Canada, Northern Ireland, New Zealand and the United Kingdom, countries that have similar safety standards for medications as the U.S.

But Dr. Alex Kappelman of the Maine Society for Health System Pharmacists, says foreign governments can't police products shipped through their jurisdictions for delivery to the U.S. And he's worried about the potential for counterfeit, inferior or expired medications to wind up in consumers' hands.

"We don't know where those countries are obtaining their medications from," Kappelman says. "Even if it's coming from Ireland, we can't be sure that those medications are manufactured in Ireland."

Kappelman says there's also a big concern about the absence of a patient-pharmacist relationship under a mail-order importation system. In Maine, for example, licensed pharmacists have educational, examination and record-keeping requirements with patients. First they have to validate the prescription, and then they have to check to make sure it's appropriate.

"We'll look for drug interactions, obviously double check that the strength is appropriate for the patient's age, weight," Kappelman says. "And after we fill that we are obligated to counsel the patient, talking about how to take it, what side effects to look for, ecetera."

Maine lawmakers recently passed the drug importation law after former Maine Attorney General William Schneider ruled that CanaRx, a Canadian mail order company, couldn't be licensed as a pharmacy. The company had been successfully providing discount drugs to city of Portland employees and Maine state workers for the better part of a decade.

In response to Schneider's ruling, Senate Majority Leader Troy Jackson of Allagash sponsored the bill to allow the state, city governments, businesses, unions and other organizations to legally contract with CanaRx to fill prescriptions. Jackson says the Canadian company charges as much as 80 percent less than some retail stores in Maine.

"The track record that they have has been excellent. Their rules and standards are as good, if not better, than the United States, so to say that there's a safety aspect, I don't believe it," Jackson says. "It's more the issue of money. In this case, they're not going to get filthy rich. They're just going to get rich."

Pharmacists are not the only ones concerned about the drug import programs. The Food and Drug Administration has repeatedly warned that medicine imported from foreign pharmacies or other sources could present health risks for consumers.

In a letter to the governor of Hawaii, for example, an FDA official said the agency could not "provide adequate assurance that the drug products delivered to consumers in the United States from any foreign country, including Canada, the UK, Australia or others are the same products that the FDA has approved through its rigorous safety and efficacy review process."

In their lawsuit, the plaintiffs allege that the drug importation law is a violation of both the Supremacy Clause and the Foreign Commerce Clause of the U.S. Constitution. Maine Attorney General Janet Mills counters that the new law simply removes a licensing requirement. In a written statement she said: "There is nothing in this act which violates any other laws and we believe that there are no grounds for the court to enjoin the law."


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