By: Jen Laws, President & CEO, Community Access National Network (CANN) & Board Co-Chair, ADAP Advocacy Association
Since 2019, Colorado has been trying desperately to put together a plan to import medications from Canada, known as a Section 804 Importation Plan (SIP) when applying for approval from the U.S. Food and Drug Administration (FDA). In December 2022, Colorado submitted its plan to the FDA (Colorado, 2022), thus joining Florida in a misguided state importation effort. Right now for patients living in both states, only the FDA is positioned to protect them from an ill-advised public policy.
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| Photo Source: Yahoo! News Canada |
For what it’s worth, Florida’s plan has not yet been approved as that state continues to go back and forth with the FDA over clarifying language. The process has dragged on so long that Florida sued the FDA to speed things up (Kansteiner, 2022). Regardless of anything else that may or may not happen in either Florida or Colorado (protip: lots of things are not going to happen), Governor Polis’ promise that Coloradans are going to begin enjoying the fruits of this labor “soon” is just not going to be a thing. But beyond process, there’s some serious problems with this idea of importing medications from Canada and the idea that it will save Americans any dollars at the pharmacy counter. Those problems have been around since the idea of importation was introduced a government “solution” nearly 20 years ago and the answers to these problems has not changed or improved.
Back when the United States started toying with importation as an idea, the Canadian government balked and even introduced legislation to block the possibility. While that legislative effort failed, it’s being revived now as Colorado and Florida push to have access to the drug supply of a country with one tenth the size of the population of the United States. Outside of Canadian legislation, distribution agreements in Canada generally curtail what can and cannot be exported to other countries, a regulatory and enforcement move that neither the United States nor Colorado can do anything about. Canada’s biggest concern remains rooted in the potential for medication shortages to meet the needs of their own population, especially given the global issue of supply shortages on critically necessary medications.
It's not just the government of Canada or even manufacturers that remain concerned about the whole host of issues importation brings. Both the Canadian Pharmacists Association and the American Pharmacists Association have repeatedly cautioned against these proposals (CPhA, APhA, 2022). Despite what Colorado says these efforts will do, helping pharmacies isn’t in the reality of this effort. Targeting contracting tricks pharmacy benefit managers use to push out competition, particularly ridiculously low reimbursement rates and narrowing of network pharmacies, would go much further toward protecting independent pharmacies and ensuring patient access to them.
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| Photo Source: CPhA, APhA |
Moving to another issue, the idea of “savings” offered under Colorado’s SIP are not rooted in reality. The first and foremost issue with any politician pitching “savings” on medication costs comes down to exactly “who” is going to enjoy these savings. Proposals to date do not establish “loss ratio” parity in medical and prescription insurance benefits – the Affordable Care Act (ACA) capped profits for medical coverage at fifteen or twenty percent but no such similar rule applies to pharmacy benefits or more commonly known as prescription drug coverage. These plans for “savings” do not necessarily translate to lower cost medications at the pharmacy counter for patients but for lower costs for governments and government programs – which should already be enjoying if those pharmacy benefit managers (PBMs) were actually fulfilling their promise of extending cost savings to their clients. They’re not and, respectfully, that’s precisely the issue most Americans care about – “What am I going to pay?” And it’s the answer politicians very carefully avoid giving.
An additional problem with Colorado’s assessment of savings is the SIP explicitly cites retail medication costs, not the costs the state government actually pays (which is often steeply discounted or enjoys rebates that bring those list prices down considerably). The calculation Colorado cites, very blatantly, is a lie.
Next, of the one hundred twelve medications Colorado specifies as targets for importation, HIV treatments are one of the highest cost medications on the list. We’ll get to why that’s particularly problematic for people living with HIV…now.
Safety security in the supply chain from importation does not align with the United States’ effort to ensure quality medications are getting to patients. The United States employs something called “track and trace” which requires electronic monitoring and labeling specific to the United States from the manufacturer throughout the entire chain of handling medications until they land in a patient’s hands. Importation from Canada (or anywhere else for that matter) would necessarily disrupt this system of tracking by requiring relabeling and Colorado, in its SIP, is challenging the FDA’s requirement to disclose when a medication is imported and from where (pg. 44-45 of the SIP). Colorado notes that while it disagrees with the relabeling requirements (which include notation when a medication is being imported without a manufacturer’s agreement), the state says it will not import medication without those same manufacturers agreeing. Generally speaking, manufacturers aren’t going to agree to participate in this program. They’ve already said so.
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| Photo Source: PhRMA |
Safety and fear of counterfeit is such a significant concern that Colorado has promised to have a third party periodically sample medications to ensure they’re authentic. And fake HIV medications have already been an issue in the United States. Part of that comes down to this exclusive reliance on private entities (namely manufacturer) to identify counterfeit medications. ADAP Advocacy Association’s CEO, Brandon Macsata, has already detailed his own, personal, potentially life-threatening experience with counterfeit antiretrovirals. And loose guardrails which muddy up securing medication safety aren’t going to make these issues any better – indeed, they’ll expose more People living with HIV to this risk.
Florida, as the other state pushing hard for importation, already knows this is a bad idea. It’s why their SIP explicitly makes the importation program medications an experiment – to be tested on the poor and imprisoned, touting to effort at addressing the state’s medications needs for Medicaid and prisons. Florida’s plan is, quite frankly, a moral and ethical disgrace. Colorado’s is rife with gimmicks.
It's high time states and the federal government appreciate that the United States, despite our issues, enjoys one of the safest medication supply chains in the world. Few if any of us stop to consider if the medications we pick up from our pharmacy are legitimate. Let’s stop with importation proposals that, in reality, won’t help patients afford medications and only threaten our supply safety, our diplomatic relationships, and patients lives. Bringing down end-user costs of medications absolutely requires government action, but that action isn’t going to be importation.
[1] Colorado (2022, December 5). Section 804 Importation Program - Colorado's Drug Importation Program. Retrieved from https://hcpf.colorado.gov/sites/hcpf/files/Colorado%27s%20Drug%20Importation%20Program%202022%20Formal%20SIP.pdf
[2] Kansteiner, Fraiser (2022, August 31). In new lawsuit, Florida says FDA stalling on drug importation program. Fierce Pharma. Retrieved from https://www.fiercepharma.com/pharma/florida-tees-legal-showdown-fda-over-stalled-information-act-request-canada-drug-import-plan
[3] Panetta, Alexander (2022, December 8). Heads up, Canada: Colorado wants your drugs. CBC. Retrieved from https://www.cbc.ca/news/world/colorado-drug-imports-canada-1.6679290
[4] CPhA & APha(2022). American and Canadian pharmacist associations warn that drug importation policies could put patients at risk. Retrieved from https://aphanet.pharmacist.com/sites/default/files/audience/Joint%20Statement%20APhA%20and%20CPhA%20Importation%20.pdf
[5] Fein, Adam (2022, December 7). Drug Channels. Retrieved from https://twitter.com/DrugChannels/status/1600660225786318848?t=y1oWO_tiLVIuQIHrkOQmmw&s=19
[6] PhRMA (2023). Drug Importation. Retrieved from https://phrma.org/policy-issues/drug-importation
[7] Partnership for Safe Medicines. (2022, September). Fake HIV Medication Reached U.S. Pharmacies—And Patients. Retrieved from https://www.safemedicines.org/2022/01/counterfeit-hiv-medications-in-the-u-s.html
[8] ADAP Blog (2020, November 19). How Drug Imports Can Endanger Patients. Retrieved from https://adapadvocacyassociation.blogspot.com/2020/11/how-drug-imports-can-endanger-patients.html
Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.
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