September 16, 2019

Safe drug imports envisioned DHHS grant sought to make system secure

A coalition of Maine interests has invited the federal Department of Health and Human Services to put its money where its mouth is. If the government is going to balk at allowing the importation of prescription drugs from Canada on the grounds that the practice may be unsafe, they say, then a system should be developed to make the process routine and secure.

The U.S. Congress recently OK’d the reimportation of prescription drugs providing the process was approved by the Food and Drug Administration. So far, the FDA has withheld that approval, citing lack of safety controls and the specter of tampering, diversion and counterfeit medications.

“If these are the questions the FDA is going to raise,” said John Carr, president of the Maine Council of Senior Citizens-Alliance for Retired Americans, “then we need to make a public record that shows how it can be safely done.”

The FDA also raised the issue of cost, telling the Associated Press last week it would cost hundreds of millions of dollars to set up a safe and legal program to import drugs from Canada. The bulk of the cost would stem from an inspection system since the FDA would not trust another country’s safety standards.

Because the Canadian government negotiates the prices it will pay for American-made pharmaceuticals, Canadian citizens pay far less than their American counterparts for the same substances. Carr said Monday his organization has applied for a $200,000 grant from DHHS, which it hopes to use to demonstrate the framework for a safe system of importing less expensive drugs from Canada. U.S. citizens would be able to buy the medications through local pharmacies at reduced prices.

The one-year pilot study was proposed in August. An early December meeting with DHHS Deputy Secretary Claude Allen went well, Carr said, and the federal official has promised to arrange future meetings, possibly as early as January, to discuss the study and the grant to fund it.

U.S. Sen. Olympia Snowe has encouraged DHHS Secretary Tommy Thompson to meet with the group to discuss supporting the project.

For the study, pharmaceuticals would be purchased at wholesale prices from a Canadian distributor, brought across the border to Indian Island in Old Town and stored in a secure, climate-controlled environment before being trucked to pharmacies around the state. Americans then could purchase the drugs at significant savings compared to prices pharmacies normally must charge.

The Indian Island storage facility stands ready, according to Tim Love, former tribal governor of the Penobscot Nation. The 40,000-square-foot former site of Olamon Industries, which made cassette tape cartridges from the mid-1980s to the mid-1990s, needs only some air-conditioning and refrigeration units to provide appropriate conditions for storing medications safely, he said.

Love, who now lives in Connecticut, has been consulting with the leadership of the Mashantucket Pequot tribe, which provides pharmacy services to its members in that state. A pharmaceuticals storage and distribution business on the Indian Island reservation would offer employment and economic development opportunities to the Penobscots, as well as benefit Mainers across the state, he said Monday. The operation would require pharmacists, security personnel, warehouse workers, shippers and other workers, he said.

The importation program would not include narcotics or other “hard drugs,” Love noted.

At the University of Maine’s Bureau of Labor Education, Director John Hanson said the university’s role would be to evaluate the security of the system, including inventory control and opportunities for tampering with or diverting the drugs.

“These are the issues that are constantly being raised [at the federal level] as the reasons why we can’t bring pharmaceuticals in from Canada,” he said. Since the government isn’t proposing a solution, he said, it may be up to small pilot studies like this to develop a standard of safety that’s acceptable to the Food and Drug Administration.

The practice of crossing the border to purchase prescription drugs for personal use is well-established among residents of Maine’s northern regions, who routinely save between 30 percent and 60 percent on the prices they would pay at a state-side pharmacy. The Maine Council of Senior Citizens organizes regular bus trips to allow elders from more southerly areas of the state to take advantage of the cheaper drugs.

“We haven’t died yet,” observed MCSC President Carr. “You don’t see our people croaking because of Canadian drugs.”

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