Vizient – Opioin Article –
After several months of D.C. chatter and countless state importation bills, FDA recently took two significant regulatory steps to allow for prescription drug importation from Canada. Wait, you thought importation was already happening in Florida? Not quite.
So, what happened? In December 2019, FDA released a proposed rule and draft guidance, each detailing a different prescription drug importation pathway. One pathway is geared toward manufacturers and is outlined in the draft guidance. The other pathway is outlined in the proposed rule (the Vizient summary is available here) and is the focus of this post.
Does this mean syringes will come filled with maple syrup?!! Will we start seeing maple leaves on prescription drug containers? Will the U.S. be able to operate a safe and effective supply of cheaper medications from north of the border? In short, hopefully not, no, and it remains to be seen.
Although the concept of traveling across borders to access less-expensive medications is not novel for people acting on their own behalf, no endorsed mechanism exists for health care providers and stakeholders to engage in this activity. The goal of the proposed rule is to help states, pharmacists and distributors compile an importation plan that would be submitted to FDA for approval, and it also outlines additional requirements related both to pre- and post-importation processes. In addition, the rule states that applicants must demonstrate cost savings to the U.S. consumer. Even though the objective of the whole endeavor is to address drug pricing, with all the regulatory requirements and additional stakeholders, importation costs may add up.
And what about those maple syrup-filled syringes? Intravenously injected medications cannot be imported under the proposed rule. Other medications that are typically in shortage or high cost, such as controlled substances, infused medications, biologics (including insulins), and drugs subject to a Risk Evaluation and Mitigation Strategy, would also be excluded.
This post expires and will no longer be available at 12:52 pm on Tuesday, February 9th, 2021Tags: Drug Importation