For the first time, the Food and Drug Administration has authorized a state to import prescription drugs from Canada, granting Florida preliminary clearance to bulk purchase medicines from wholesalers there. The decision is a major policy shift for the agency, which has long resisted drug importation efforts on grounds that it could not ensure the safety and supply of medicines shipped from abroad. Supporters have argued that importing drugs from Canada, where medicines cost far less than in the United States, could help lower pharmaceutical costs. Florida will still need to overcome several significant hurdles before it can begin to import any Canadian drugs.
More on Importation
Generally, there are three pathways to importing a prescription drug into the United States: personal importation, manufacturer imports of multi-market-approved products, and the SIP pathway. The Section 804 Implementation program (SIP) pathway is relatively new and is the first pathway to be independent of the individual patient and the drug manufacturer. A SIP is a “pathway” under Section 804 of the Federal Food, Drug, and Cosmetic Act allowing for the importation of certain prescription drugs from Canada, provided that the SIP’s sponsor demonstrates that the SIP “will result in a significant reduction in the cost of eligible prescription drugs to the American consumer without posing any additional risk to the public’s health and safety.”
Florida reported that it expects to save approximately $183 million annually once its SIP is implemented. Before Florida can begin importing drugs, however, the state’s Agency for Health Care Administration must submit additional drug-specific information for the FDA’s review and approval, ensure eligible prescription drugs have been tested for authenticity and degradation and are in compliance with the specifications and standards set forth in Section 804(e)(1) of the FD&C Act, and relabel the eligible prescription drugs to be consistent with the FDA-approved labeling requirements.
While Florida’s proposal is the first SIP authorized by the FDA, it likely will not be the last. In an FDA news release announcing the authorization, FDA Commissioner Robert Califf said the FDA “is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals.” At least eight other states have submitted SIPs to the FDA for approval. Seven additional states have enacted laws permitting them to create and submit SIPs for authorization. There is additionally bipartisan support for importation proposals.
But this will come with challenges. First, there will likely be imminent and robust litigation challenging FDA’s authorization of the Florida SIP proposal and FDA’s denial on January 5, 2024 of the Citizen Petition submitted by PhRMA and other petitioners requesting that FDA refrain from authorizing Florida’s SIP proposal. Second, the Canadian government is likely to oppose implementation of any SIP proposal based on concerns that it may lead to drug shortages for Canadian citizens and threaten supply chain security for both U.S. and Canadian markets. Third, Florida may find it difficult to find and maintain foreign sellers who are willing and able to sell drugs for export to the U.S. under a SIP. Pharmaceutical manufacturers that currently sell drugs to Canada and also directly to U.S. markets will likely explore options to limit or restrict drugs that will be exported from Canada to the U.S. under any SIPs that FDA authorizes.