With the rising cost of health care, many US citizens are crossing into Canada to buy less expensive prescription drugs. In fact, a group from Maine, consisting of state employees, Portland employees, and one large company, claims to have saved approximately $10 million over several years by purchasing their drugs through a Canadian mail-order pharmacy. However, the legality of importing drugs into the US continues to be a gray area.
Illegal for Individuals to Import Prescription Drugs?
According to the FDA
“In most circumstances, it is illegal for individuals to import drugs into the United States for personal use. This is because drugs from other countries that are available for purchase by individuals often have not been approved by FDA for use and sale in the United States.” However, the FDA typically allows for exceptions under the following circumstances:
- The pharmaceutical drug is for use for a serious condition for which effective treatment is not available in the United States;
- There is no commercialization or promotion of the drug to U.S. residents;
- The drug is considered not to represent an unreasonable risk;
- The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country; and
- Generally, not more than a 3-month supply of the drug is imported.
Act to Facilitate the Personal Importation of Prescription Drugs from International Mail-Order Pharmacies
In 2012, a former state attorney general in Maine decided to ban companies that were importing drugs from conducting licensed business in Maine. This move was in response to a complaint from the Maine Board of Pharmacy that foreign pharmacies were not licensed under law. This ban stopped the savings some individuals in the business community and the state and local governments were receiving.
In response to the ban, state senator, Troy Jackson introduced the “Act to Facilitate the Personal Importation of Prescription Drugs from International Mail-Order Pharmacies” - an act that allows its residents to purchase prescription drugs from mail-order pharmacies in Canada, the UK, New Zealand, and Australia. Maine’s state legislature overwhelmingly passed the act and the law went into effect on October 9, 2013.
The Lawsuit - Big Pharma & Others Weigh In
The Pharmaceutical Research and Manufacturers of America, the Maine Pharmacy Association, Maine Society of Health-System Pharmacists, and others filed a lawsuit against the state of Maine, stating that the law circumvents “the carefully constructed closed federal regulatory structure governing prescription drugs and thus posing serious health risks to consumers.” The lawsuit further argues, “Prescription drugs shipped to Maine by foreign pharmacies pursuant to the (law) are not subject to any of the quality and safety controls put in place by the federal government in order to protect persons who rely on prescription medications.”
This discussion is not over. Currently, Maine is seeking dismissal of the lawsuit and the plaintiffs are requesting an Oral Argument.
For the Act
Sharon Anglin Treat, National Legislative Association on Prescription Drug Prices, said, “This legislation will save money for Maine consumers, businesses, and local and state governments and provide access to high quality medications. Prescription drug prices in the US are the highest in the developed world… Until such time that we join other countries in making drugs affordable, importation in the manner enacted by Maine Legislature makes eminent sense.”
Against the Act
Marv Shepherd, Partnership for Safe Medicines, stated, “However well-intentioned Maine’s importation legislation may be, the health risks of counterfeit medicines far outweigh any cost savings. The bottom line is that the FDA cannot guarantee the safety or efficacy of any prescription medication from outside the US supply chain, and when medicines are not FDA approved patients are put in danger.”
Implications are Clear
Should the lawsuit by PhRMA, et al, be unsuccessful, it will open the doors for easy access to lower priced brand name prescription drugs enjoyed by residents of other countries, at least in the state of Maine. Other groups seeking to save money on prescription drug costs may use this as an example and press for similar legislation in other states.
In states where the Pharma industry has less influence, and there is generally less support for industry protection in general, these bills are more likely to succeed.