Imported Drugs: (Possibly) Coming Soon to a State Near You

In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from the US Food and Drug Administration (FDA) for importation programs under Section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA) to import prescription drugs from Canada. These “Section 804 Importation Programs” (SIPs), if approved, would enable states to import prescription drugs from Canada, often at significantly lower prices than those available in the United States.

After years of legal and other challenges to the rule, on January 5, 2024, the FDA authorized Florida’s SIP proposal. While eight other states have laws that permit drug importation, and six of them are seeking FDA approval, this is the first time that the FDA has approved a state entity to import drugs from another country. Following Florida’s example, Colorado and other states are moving forward with their own SIP plans.

Read more here.

James Ravitz
James (Jamie) Ravitz is the co-head of the Firm’s Life Sciences industry practice and head of McDermott’s Food and Drug Administration (FDA) practice. He works alongside clients across the entire spectrum of life sciences and healthcare law, including regulatory counsel, compliance, and investigations and government enforcement. He is particularly focused on Food and Drug Administration (FDA) regulatory counseling. Jamie works in partnership with companies and investors across the complete ecosystem of FDA-regulated products—drugs, devices, health technologies, biologics, food, cosmetics and cannabis— to help them achieve their business goals. Read James R. Ravitz's full bio.

Paul Gadiock
Paul Gadiock leverages his firsthand experience at the Food and Drug Administration (FDA) to provide life sciences, healthcare and other FDA-regulated companies with practical, strategic counsel at every phase of the product life cycle. Paul supports medical device, digital therapeutic, and biopharma companies, software as a medical device (SaMD) and clinical decision support (CDS) developers, and their investors on their FDA regulatory and due diligence needs, delivering premarket and postmarket regulatory guidance to maximize business outcomes. Read Paul S. Gadiock's full bio.

Marissa Hill Daley
Marissa Hill Daley focuses her practice on healthcare and US Food & Drug Administration (FDA) matters, including advising clients on regulatory compliance, government and internal investigations, and FDA marketing requirements. Marissa also defends clients against whistleblower qui tam suits that involve the False Claims Act and the Anti-Kickback Statute. Read Marissa Hill Daley's full bio.

Nathan Gray
Nathan Gray is a member of the Healthcare Practice Group. While earning his law degree, Nathan served as a summer associate at McDermott. He was a legal fellow at Compassion and Choices in Portland, Oregon, and served as internal vice president of the Health Law Society at Duke University School of Law. Read Nathan Gray's full bio.

Karis Jackson
Karis Jackson advises healthcare clients on diverse transactional and regulatory issues related to managed care, healthcare policy, US Centers for Medicare & Medicaid Services due process, and Food & Drug Administration and Federal Trade Commission guidance. Her clients include private equity and practice management companies, public and private companies, and healthcare organizations. Read Karis Jackson's full bio.




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