CPPI recently submitted comments to the Food and Drug Administration (FDA) regarding its Notice of Proposed Rulemaking to allow importation of certain prescription drugs from Canada.
Through our comments, we wanted to ensure that personal importation is not negatively affected by the proposed rulemaking on drug importation.
Regulators and lawmakers have created the current environment that permits millions of Americans to import medications for personal use. Personal use is defined as a 90 day or less supply. FDA’s published guidance allows for discretion on a case-by-case basis concerning Americans’ ability to import prescription drugs for personal use: “FDA personnel may allow entry of shipments when the quantity and purpose are clearly for personal use, and the product does not present an unreasonable risk to the user.”
Congress has repeatedly passed laws to protect Americans who import medicines for personal use. For example, annual Homeland Security Appropriations legislation has included a provision to protect Americans who import on their person a “personal-use quantity of a prescription drug, not to exceed a 90-day supply” by preventing Customs and Border Protection from seizing their medicines (provided the drug in question is not a controlled substance or a biological product).
This protection for personal importation has been Congressionally-mandated and signed into law by the president every year since 2012. The “SUPPORT for Patients and Communities Act” – passed by wide bipartisan margins in 2018 – explicitly created a protection for Americans who import “in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer.”
We believe that FDA’s proposed rulemaking on drug importation misses a critical opportunity to provide a clear legal pathway for personal importation. Unlike the wholesale importation process outlined in the proposed regulations, recognition of a legal pathway for personal importation would have an immediate impact for Americans. Millions of Americans are already accessing safe and affordable prescription drugs from Canada.
For the full letter, please click here