Policy implications of drug importation

Abstract

Background: Importation of prescription drugs into the United States has been a major health policy issue for some time. The original objective of personal importation was to allow patients to have access to drugs that were not available to them in the United States either for continuation of therapy begun in another country or when all US Food and Drug Administration (FDA)-approved drug options for their condition had been exhausted. An increasing proportion of personally imported drugs are currently marketed in the United States, but imported drugs are presumably available at a lower cost to the consumer. As US consumers opt for importation through Internet sites and other means of purchase from other countries, potential risks of exposure to counterfeit products have increased, presenting challenges to both the US regulatory system and pharmaceutical companies. Objective: This commentary summarizes the current state of importation of prescription drugs into the United States. Conclusions: Regulators and policymakers are under increasing pressure to address the high cost of branded drugs in the United States and the desires of many US patients to purchase less expensive formulations of these products through importation. In many cases, the historical policies surrounding personal importation of prescription drugs that are not sold in the United States have been blatantly ignored, leaving the FDA in a quandary. While current legislative proposals would allow for greater access to drugs directly to consumers from other countries, they do not address the fact that the FDA has no ability to monitor the safety and efficacy of imported products. As such, the possibility of the entry of counterfeit medications and the related potential harm remain concerns.