WASHINGTON – November 30, 2020 – In response to the U.S. Food and Drug Administration’s (FDA) Importation of Prescription Drugs Final Rule taking effect today, the Alliance for Safe Online Pharmacies (ASOP Global) issued the following statement of opposition:

With the drug importation final rule becoming effective today, ASOP Global continues to urge policymakers, including President-elect Biden and Congress, to address America’s drug pricing concerns with policies that do not place U.S. consumers in harm’s way. ASOP Global has consistently voiced its strong opposition to the Trump Administration’s Safe Importation Action Plan – and the subsequent policies they have put forth – since it was published in July 2019. These politically driven policies disregard public health and patient safety concerns and threaten the quality, safety and legitimacy of prescription drugs sources entering America’s complex and highly regulated supply chain. The Biden Administration should take immediate action in the new year to rescind this reckless Trump Administration rule and put in place its own sensible policies to protect the nation’s drug supply – and the patients whose lives depend on them.

The Final Rule does nothing to resolve the underlying factors fueling America’s drug pricing dilemma. Rather, it introduces new health risks to the system that directly contradict more than 20 years of science-based leadership at the FDA and Department of Health and Human Services. Not only would importing prescription drugs from Canada weaken controls on our historically safe pharmaceutical supply chain but it may falsely signal to consumers the safety of drugs sourced from abroad. Despite the language of the rule, the implementation of the final rule could be seen as a de facto government seal of approval that all “Canadian” medicines sold online are safe and legitimate. We know this is just not true: the FDA’s own research has shown that upwards of 85% of drugs claiming to be from Canada actually come from other countries.

The move to open our borders to foreign-sourced medicine comes at a time when American consumers are at their most vulnerable. Alarmingly, ASOP Global’s recent national survey shows that almost half of U.S. consumers think buying medicine from online pharmacies is worth the risk, trending up alongside an overall increase in consumer usage of the internet for healthcare-related services. At the same time, illegal online drug sellers are exploiting the COVID-19 pandemic through an unprecedented number of illicit, unsafe websites. As news of the Final Rule likely drives more American patients to unknowingly access dangerous fake medicines online, it will also increase the risk for consumer harm and put additional undue strains on the country’s pharmaceutical supply chains. While the nation grapples with a comprehensive and coordinated response to COVID-19, this is simply not the time to divert resources away from the pandemic and towards policies that place U.S. patients at risk.

Public health officials, economists and patient advocacy organizations all agree that sourcing foreign medicines is a dangerous scheme that will not solve our domestic political and drug pricing issues. Canadian stakeholders, too, have expressed concern around the impacts of the final rule and impracticality of such policy proposal. Legislators and regulators must put workable, science-based policies in place that safeguard the quality of the drugs that U.S. patients rely upon daily for their health.

ASOP Global looks forward to serving as a resource for the Biden Administration, Congress and states in their efforts to make safe, FDA-approved medicines more accessible and affordable to American patients. We urge policymakers and regulators to reconsider the false promises of foreign-sourced drugs and instead prioritize policies that protect patients from illegal online drug sellers masquerading as “Canadian pharmacies,” close illicit internet markets and hold domain name registrars and registries accountable. Please visit our website for additional information on drug importation.

###

ABOUT ASOP GLOBAL

The Alliance for Safe Online Pharmacies (ASOP Global), a 501(c)(4) nonprofit organization headquartered in Washington, D.C. with activities in U.S., Canada, Europe, Latin America and Asia, is dedicated to protecting consumers around the world, ensuring safe access to medications, and combating illegal online drug sellers.