Author: Ben Penley
Per capita, prescription drug costs in the US are the highest among all countries.1 High costs have a direct impact on access: 79% of patients find prescription drug costs unreasonable and 25% have difficulty affording their medications.2,3 Barriers to access in the form of high prescription drug costs lead to decreased medication adherence and poorer health outcomes.
Leading up to the 2020 presidential election, high drug costs have emerged as a central issue. Increased debate on this topic has led to numerous and varied proposed solutions. One such proposal—the importation of prescription drugs from Canada and other countries—has the support of President Trump, presumptive Democratic nominee Joe Biden, and 80% of the public.2,3 Though prescription drug importation is not a new idea, the groundswell of support from political frontrunners has brought renewed attention.
In December 2019, the Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) issued a proposed rule regarding drug importation to establish a pathway for states, wholesalers, licensed US pharmacies, and manufacturers to import prescription drugs from Canada.4 The proposed rule offers two pathways for prescription drug importation.
The first pathway allows states, wholesalers, and pharmacists to submit a plan outlining their method of importing prescription drugs from Health Canada in a ‘demonstration project’ that must meet metrics associated with safety and a reduction in prescription drug costs to American consumers. As of May 2020, five states have begun drafting or submitted plans for prescription drug importation (Florida, Vermont, Colorado, Maine, and New Mexico).5 It is worth noting, however, that this pathway for drug importation excludes some of those drugs with the most bemoaned prices (e.g., biological products, such as insulin).4
The second pathway allows manufacturers to import their FDA-approved drugs sold in foreign countries back into the US. FDA/HHS believe that some manufacturers might participate in this pathway as a means to offer their drugs at a lower cost and under a new NDC, outside of contractual obligations with other players in the US supply chain. While this pathway does not exclude expensive biological products, no manufacturers have yet expressed interest.
Though efforts to lower prescription drug costs are well-intentioned, plans for prescription drug importation have been widely criticized. Among others, the American Pharmacy Association (APhA) and the National Alliance of State Pharmacy Associations (NASPA) contend that drug importation programs would not effectively reduce prices and place US patients at undue risk.6 There are also concerns that importing prescription drugs could introduce low-quality medications into our closed US supply chain. The US track-and-trace system could be subverted with importation programs, as Canadian pharmacies are, understandably, not in compliance with track-and-trace US laws.7
With growing concern from patients and politicians, there is sure to be continued interest and action on sensible policies that reduce prescription drug costs. In the coming months and years, legislators and major players in the prescription drug supply chain will have to consider whether drug importation proposals pass this test.
Ben Penley is a fourth year Doctorate of Pharmacy student at the UNC Eshelman School of Pharmacy.
Kesselheim AS, Avord J, Sarpatwari A. The high cost of prescription drugs in the United States: origins and prospects for reform. JAMA. 2016;316(8):858-871.
Kirzinger A, Lopes L, Wu B, Brodie M. KFF Health Tracking Poll – February 2019: Prescription Drugs. Kaiser Family Foundation. https://www.kff.org/health-reform/poll-finding/kff-health-tracking-poll-february-2019-prescription-drugs/. Published March 01, 2019. Accessed February 20, 2020.
Do you support importing drugs from other countries? The Washington Post. https://www.washingtonpost.com/graphics/politics/policy-2020/medicare-for-all/drug-importation/. Accessed February 20, 2020.
Importation of Prescription Drugs. 21 C.F.R. §1 2019.
Freed M, Neuman T, Cubanski J. 10 FAQs on Prescription Drug Importation. Kaiser Family Foundation. https://www.kff.org/medicare/issue-brief/10-faqs-on-prescription-drug-importation/. Published March 19, 2020. Accessed July 3, 2020.
Pharmacy Call to Action: FDA Drug Importation Proposal Jeopardizes Patient Safety. https://www.pharmacist.com/drug-importation. Accessed March 3, 2020.
Fein AJ, Rodgers D. State drug importation laws undermine the process that keeps our supply chain safe. STAT. https://www.statnews.com/2019/07/11/state-drug-importation-laws-undermine-supply-chain-safety/. Published July 11, 2019. Accessed March 3, 2020.