High-priced prescription drugs have been a problem for U.S. consumers. The United States market economy coupled with patent protection for these products creates an incentive for pharmaceutical companies to charge as much as possible. Unable to afford these drugs, many people are reaching out to neighboring countries and abroad to seek lower-cost options. It has also created a market for online mail-order pharmaceuticals. Despite the need for these drugs, the Food and Drug Administration (“FDA”) continues to make importation illegal. In formulating its policy, the FDA cites to safety and innovation concerns. Claimed uncertainty about the source of foreign prescription drugs has led to ineffective federal policy in this area. To date, none of the major amendments to the Food, Drug, and Cosmetic Act have successfully provided a framework for securing foreign importation. Without proper federal guidance, various states, including Maine, have implemented legislation to facilitate the importation of prescription drugs from other developed countries like Canada and England. This Article proposes two potential solutions to implement policy on the federal level. With an eye towards Maine’s new law and its successes, there is potential for an expanded, codified personal use exemption. Moreover, using “qualifying” countries, or those with an adequate level of manufacturing oversight for prescription drugs, may provide an alternative safeguard for allowing importation.
Prescription Drug Importation: An Expanded FDA Personal Use Exemption and Qualified Regulators for Foreign-Produced Pharmaceuticals,
Loy. Consumer L. Rev.
Available at: https://lawecommons.luc.edu/lclr/vol27/iss3/2