December 9, 2019
Vermont officials recently submitted a concept paper to the Department of Health and Human Services and Food and Drug Administration outlining the state’s plan to import prescription drugs from Canada in accordance with legislation passed last year. As provided in the concept paper, drugs imported under the state’s program would be subject to the following safety requirements:
- Be FDA-approved, not adulterated, and not misbranded;
- Comply with federal registration and listing requirements for supply-chain participants (e.g., documentation, track-and-trace, etc.);
- Be subject to FDA examination at the border; and
- Otherwise comply with federal law (e.g., no controlled substances, infused drugs, etc.).
Vermont’s submission to the Agencies follows a similar submission by Florida earlier this year. While the two plans share similar approaches to ensuring safety, they differ with respect to payer participation. Specifically, Florida’s program is limited to public payers, whereas Vermont’s plan would allow participation by both commercial and public payers. Other states that passed prescription drug importation legislation this year, including Colorado and Maine, appear poised to follow Vermont’s approach.
These concept papers are not final submissions, though Vermont Governor Phil Scott has said that the state will submit a formal application to the Agencies by July 1, 2020. Rather, they offer federal regulators insight and guidance as the Administration works to develop a proposed rule to authorize drug importation from Canada. The proposed rule is expected in early 2020.