On January 5, 2024, the Food and Drug Administration (FDA) authorized the state of Florida’s proposal under the Section 804 Importation Program (SIP) for a period of two years. FDA’s action marks the first time a state drug importation program has been authorized pursuant to the 2020 final rule implementing the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The MMA amended Section 804 of the Federal Food, Drug, and Cosmetic Act to permit FDA to issue regulations governing the importation of prescription drugs from Canada only after the Secretary of Health and Human Services has certified that implementation of section 804 would “pose no additional risk to the public’s health and safety” and “result in a significant reduction in the cost of covered products to the American consumer.”
FDA’s authorization of Florida’s SIP proposal is only the first step of many laid out in FDA regulations that must be taken for Florida to import drugs. For each drug Florida seeks to import, FDA must review and approve a Pre-Import Request, which must include a detailed testing plan to demonstrate authenticity and compliance with established standards and specifications, an attestation and information statement from the drug manufacturer that the drug meets all conditions of the FDA-approved drug and extensive additional information.
On January 8, 2024, Health Canada issued a statement reiterating its long-standing position that “bulk importation will not provide an effective solution to the problem of high drug prices in the U.S.” and indicating that the Government of Canada is “taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need.” In 2020, Canada issued a rule that prevents Canadian-based manufacturers and wholesalers from exporting drugs in short supply.
In addition to facing near-certain difficulties surrounding securing adequate supply of Canadian drugs, Florida is likely to confront implementation challenges in the form of litigation by the pharmaceutical industry and other stakeholders seeking to reverse FDA’s authorization of the Florida SIP. In November 2020, PhRMA, the Partnership for Safe Medicines, and The Council for Affordable Health Coverage filed a complaint challenging FDA’s 2020 final importation rule; that case was ultimately dismissed in February 2023 for lack of standing.
Eight states have enacted legislation authorizing drug importation programs and another six states are currently considering drug importation legislation. Of the eight states that have enacted legislation, six have submitted SIP proposals to FDA (Table 1). Although the Biden Administration has taken a significant step forward in authorizing Florida’s SIP, it remains to be seen whether widespread Canadian drug importation will occur in the U.S.
