On October 9th, Maine passed a new law allowing citizens of the state to directly import prescription drugs from foreign pharmacies. This law, the first of its kind in the United States, was implemented in an attempt to lower the cost of prescription drugs. While the law’s national impact remains unknown, other states may create similar laws if the law successfully lowers the costs of prescription drugs for Maine’s citizens. This creation of new laws could have adverse effects on pharmaceutical companies.
In a recent Wall Street Journal article, economics professor Laurence Kotlikoff stated, "[i]f Maine can do this, other states will do this. It could have a big impact on pharmaceutical companies' long-term profits and desire to invent new medications." These impacts may not be simply a consequence of new competition to the pharmaceutical market; they may be a consequence of unfair competition in light of FDA safety regulations on non-foreign drugs. While the FDA regulates the importation of drugs, the agency does not focus its enforcement powers on consumers, and the FDA has been unable to release a statement to address this new law because of the ongoing government shutdown.
Some have argued that the Maine law, barely more than a page in length, is inadequate to address these issues, especially without FDA input. In response to these concerns, trade groups PhRMA, Maine Pharmacy Association, and Maine Society of Health-System Pharmacists sued the state in mid-September, contending that the Maine law violates the FDCA. Specifically, the groups allege that the law “poses an obstacle to the federal government's ability to achieve the goals of its prescription drug regulatory regime and is an invalid attempt at legislating in a field totally occupied by the federal government."