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January 5, 2024, the FDA authorized Florida’s Canadian drug importation request under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Response articles have boomed, both in support and against the FDA’s response. We encourage those with questions to read the FDA Press Release directly for their rationality and requirements. In short, we summarized a few key facts from the press release. The decision was made consistent with President Biden’s Executive Order on Promoting Competition in the American Economy to lower drugs while ensuring public health and safety. The decisions is authorized for 2 years pursuant to: before drugs can be imported, Florida’s Agency for Health Care Administration must (1) “Submit additional drug-specific information for the FDA’s review and approval” to import (2) “Ensure the drugs requested for importation have been tested for, among other things, authenticity and compliance with the FDA-approved drugs’ specifications and standards” (3) “Relabel the drugs to be consistent with the FDA-approved labeling.” The Florida agency must also provide quarterly update with identified savings and any potential safety and quality issues.
Eight states are in the process of reviewing and potentially seeking importation approval. For those who have evaluated personal drug importation programs, do not to be confused with this ruling which applies to State and Tribal agencies, not individuals.
Aside from the arguments both for and against this decision, logistical obstacles will need to be addressed to implement such efforts. Two significant issues include contracts between drug wholesalers and Canadian companies that forbid exportation of their stated drugs to outside entities; and the Canadian Health agency taking steps to block exportation of drugs that are in short supply.
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