A first-in-nation law that allows  prescription drug imports will risk Mainers’ lives, as it puts the drugs beyond the reach of FDA regulations.

Maine has become the first state in the nation to allow individuals to purchase prescription drugs abroad in a new law which passed in June without the signature of Governor LePage. The non-emergency measure went into effect on Oct. 9.
Titled, “An Act to Facilitate the Personal Importation of Prescription Drugs from International Mail Order Prescription Pharmacies,” the law permits licensed retail pharmacies in the United Kingdom, Canada, New Zealand and Australia to export prescription drugs to residents of Maine for their personal use through an unlicensed “entity” or intermediary, which could be located anywhere in the world. These imported drugs often come at a much lower price to patients than prescription medicine manufactured and regulated in the United States.

There is no question that prescription medication produced in the United States is expensive; legislators in Augusta have acted too quickly and without appropriate caution in an attempt to reduce drug costs. Pharmaceutical professionals have raised reasonable concerns regarding the safety, privacy and licensure of these transactions.

The purity standards with which drugs are produced and their accurate labeling are heavily regulated in the United States. This new state law, however, shatters our safe and secure drug supply system. Following a “spot check” investigation in 2003, the FDA reported that up to 69 percent of prescription drugs in mail shipments from foreign countries were unsafe, and that Canadian parcels accounted for 80 percent of those. These potentially dangerous products included unapproved drugs, drugs withdrawn from the U.S. market for safety reasons, improperly labeled drugs, and animal drugs not intended for human use.

Apparently, legislators find this to be an acceptable risk to Mainers’ health. It must be understood that just because it’s good enough for Canada, it is not necessarily good enough for Maine.

Although importing prescription drugs prior to this new law was illegal, Maine rep. Sharon Treat, D-Hallowell, stated in a radio interview that it has been successful for many years in Maine.  Though she claimed that, to her knowledge, no unsafe parcels have been imported to Maine, the FDA statistics cannot be misunderstood. It is careless to assume unsafe parcels have not been sent to Maine by mail shipments, simply because there have been no reports.

Maine residents are offered very little protection under this new law. Unlicensed brokers can conceivably operate from anywhere in the world to ship and sell drugs to people in Maine. The law does not require foreign pharmacies or importation facilitators to verify the legitimacy or appropriateness of prescriptions being filled. Therefore, when a medication from an international broker causes harm due to a counterfeit or contaminated prescription drug being shipped to their home, there is no legal protection provided for these patients in Maine. They will not be able to file a complaint against an unlicensed broker with the Maine Board of Pharmacy, as there can be no regulatory or legal recourse against an unlicensed broker.

Under this new law, these imports could even include controlled, addictive prescription drugs such as oxycodone and morphine sulfate. With over 30,000 opiate addicted Mainers already lacking access to appropriate care, risking an increase in addiction levels is irresponsible.  In short, patients’ lives are at risk.In regard to privacy, international mail order brokers are not required to comply with the Health Insurance Portability and Accountability Act, which means they have the freedom to violate and sell your protected health information without any consequences.

Pharmacy practice in Maine is a very closely regulated profession––and for good reason. Patients in Maine rely on counseling from licensed pharmacists to learn drug interactions, to monitor side effects and to receive instructions for use. Beyond that, Maine pharmacists regularly consult directly with prescribing physicians when questions arise about a prescription.

This new law, condoning the importation of mail order prescription drugs, deprives Maine residents of essential functions that Maine pharmacists provide. Instead, a conduit has been carelessly produced to facilitate the entry of counterfeit, adulterated or expired medications into Maine.  Patients’ health and safety must be of higher priority than reducing prescription drug costs.

Bryan Bonin is a senior political science major with a concentration in law.

6 COMMENTS

  1. The new law does NOT allow “unregulated drug imports”. Because drug prices are out of reach for so many Americans it’s critical to public health that people are fully informed. The law permits “licensed” pharmacies in Australia, Canada, New Zealand, and the UK to dispense medication to people residing in Maine for their own use. Let’s just look at the actual law; it reads:

    “A licensed retail pharmacy that is located in Canada, the United Kingdom of
    Great Britain and Northern Ireland, the Commonwealth of Australia or New Zealand
    that meets its country’s statutory and regulatory requirements may export prescription
    drugs by mail or carrier to a resident of this State for that resident’s personal use.”(Source; The Law – http://www.mainelegislature.org/legis/bills/getPDF.asp?paper=SP0060&item=4&snum=126).

    Luckily for the peoples of these Commonwealth countries, medications and pharmacies are highly “regulated” – but just a lot less expensive. Maine legislators seem to have more courage than most politicians on this issue and should be commended.

    Gabriel Levitt
    Vice President
    PharmacyChecker.com

    • They ARE unregulated by the FDA, however. The law also allows for “entities” or brokers to send prescription drugs to Maine residents. This allows for more than just licensed pharmacies in these countries to export drugs. These “entities” are not required by this Maine law to be licensed in any way by the foreign country. Please do not reference only one portion of the law to argue your case. By excluding sections that don’t fit into your argument, you lose credibility. The section of this law you quoted is not the only vital piece of information.

      • Dear Rainman –

        Thank you for bringing up that point. Let’s look at that language, too:

        “An entity that contracts to provide or facilitate the exportation of
        prescription drugs from a licensed retail pharmacy described in paragraph B may provide or facilitate the provision of prescription drugs from that pharmacy by mail or
        carrier to a resident of this State for that resident’s personal use.”

        In this case an “entity” – which could be a PBM, or broker, can dispense medication or facilitate the dispensing of medication through “a licensed pharmacy described in paragraph B.”
        So, no matter who is doing the facilitating, the products, under this law, must be dispensed from a licensed pharmacy in the countries identified in paragraph B. For instance, said “entity,” let’s call them HelpAmericansRx, can act as manager for the dispensing of medication from licensed pharmacies in Australia,
        Canada, New Zealand, the UK, but NOT France, Spain, or Japan. Thus the law does NOT permit an entity that is not a pharmacy from shipping medications to residents of Maine.

        I thought this was obvious and therefore unnecessary to address so I’m glad you brought it up. Feel free to come out of the shadows and introduce yourself; then we can hopefully
        share “credibility.”

        Gabriel Levitt
        Vice President
        PharmacyChecker.com

    • Bonin includes the difference between a “licensed” pharmacy and an “unlicensed” entity and how they relate to the law within the second paragraph of his article. The issue isn’t necessarily with the regulation of “licensed” foreign pharmacies, but rather with the lack of regulation afforded “unlicensed” entities who can also sell Mainers mail order prescription drugs.

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