On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval.[1]

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. Personal importation is when an individual imports prescription drugs for their own use and not for further sale or distribution. There is little enforcement by the FDA against personal importation. Practically, if individuals follow the FDA’s guidance on personal importation, then the FDA will allow a 90-day supply of drug products to be imported into the U.S. by an individual. Drug manufacturers may import FDA-approved drugs that are also authorized for sale in a foreign country in which the drugs were originally intended to be marketed — multi-market-approved products. A manufacturer could import such a drug if the drug is manufactured outside the United States and the manufacturer has authorized marketing of the drug in the United States and has caused the drug to be labeled to be marketed in the United States. The 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 (FD&C 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.”[2]

Florida reported that it expects to save approximately $183 million annually once its SIP is implemented.[3] But this might not be for some time. Before Florida can begin importing drugs, the state’s Agency for Health Care Administration must (a) submit additional drug-specific information for the FDA’s review and approval, (b) 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 (c) 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 affirmed that 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. And Republicans and Democrats alike have championed drug importation in this election cycle.

Florida’s SIP is an additional mechanism (along with the Medicare/CMS negotiations and potentially march-in rights) used by the current administration in an attempt to lower drug prices. The key for the healthcare and life sciences industries is to monitor how these programs are implemented and executed.

[1] Letter, Sandi L. Verbois, Director, Office of Drug Security, Integrity & Response, to Jason Weida, Secretary, Florida Agency for Health Care Administration (Jan. 5, 2024).

[2] Importation Program Under Section 804 of the FD&C Act, FDA, https://www.fda.gov/about-fda/reports/importation-program-under-section-804-fdc-act (content current as of Jan. 5, 2024).

[3] Tami Luhby, FDA Approves First State Request to Import Drugs from Canada, CNN (Jan. 5, 2024), https://www.cnn.com/2024/01/05/politics/florida-canada-drug-imports-fda/index.html.

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