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Web posted
This scary scenario is not a story. It happens every day, across the country, and here in Alaska. One estimate calculated that 20 million packages containing pharmaceutical products are now imported into the U.S. every year, an increase of 1,000 percent since 2001, when the Federal Drug Administration first warned about this problem.
Patient safety is the primary concern of pharmacists, and the most compelling reason for Congress to reject H.R. 2427, the Gutknecht-Emerson-Burton-Emanuel bill to allow imported drugs to enter the U.S. market.
While Alaska pharmacists and pharmacies are required by state and federal law to be licensed and regulated by the Alaska Board of Pharmacy, pharmacies located in Canada are not required to be licensed. If an Alaska patient is injured or harmed by a medication or if the patient's condition is non-responsive to the Canadian medication, and it turns out to be counterfeit, there is nothing the Alaska Board of Pharmacy can do to assist the Alaska patient.
Consumers have no recourse if they receive counterfeit, contaminated or substandard medicine. Most Canadian firms require patients to sign a document that waives all rights to hold the Canadian pharmacy, or pharmacist (if one is even present) liable.
Imported drugs are discounted, usually for a reason. While the U.S. Food and Drug Administration closely monitors the quality and manufacturing of drugs in the U.S., illegally imported drugs do not fall under the same scrutiny. Products manufactured in Canada solely for export sale are not required to comply with Canada's Health Protection Bureau guidelines and are exempt from Canadian laws on product safety.
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Safety is not the only thing at stake, should this bill pass. Imported drugs are having a negative impact on small businesses like pharmacies, and the pharmacists that they employ. Pharmacists perform an important function in communities like mine. They answer consumer health questions, and provide invaluable advice and services. Their compensation derives from the quality of their services and the products that they provide.
Reimported drugs will undercut the ability of pharmacies to recoup the costs associated with providing these goods and services. Americans should feel free to talk to someone who can answer their questions about a drug, and who can recommend a lower cost generic product, or call the physician to see if a lower cost drug is appropriate.
H.R. 2427 strips provisions from H.R. 1, the House-passed Medicare prescription drug bill, requiring the Secretary of Health and Human Services to attest that imported drugs "pose no additional risk" to the safety and health of American consumers. Instead, H.R. 2427 would "create a wide inlet for counterfeit drugs and other dangerous products," as the Food and Drug Administration has commented, by weakening the safety provisions contained within H.R. 1.
Are you willing to play Russian Roulette with your health, and possibly your life? Ten consecutive FDA Commissioners have warned against the dangers of imported medicines. Yet thousands of U.S. consumers, many of them seniors, take enormous personal risks every day by purchasing their medications from unknown sources.
The task before Congress is to enact a Medicare Prescription Drug Benefit that brings people back home for their medication needs. Potential harm is everywhere in sight where imported medicines are concerned, and opening the floodgates wider cannot be the answer.
We need to maintain the safety provisions in the current law, or face the consequences. The most expensive medication is the one that doesn't work -- or worse, causes harm.
Roger Mortemore is a Fairbanks-based pharmacist and is community of affairs director of the Alaska Pharmacist Association. He can be reached at r.mortemore@att.net.
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