On May 21, 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a notice on its FDA.gov website (FDA.gov Notice) describing how the Agency plans to help states and Indian tribes more effectively and efficiently develop proposals to import prescription drugs from Canada under section 804 (21 U.S.C. 384) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), for potential authorization by FDA.
The May 21 FDA.gov Notice frames these plans as part of the Agency's efforts to effectuate President Trump's April 15, 2025 Executive Order (EO), "Lowering Drug Prices by Once Again Putting Americans First."1 Among other things, that EO directed FDA to take steps to streamline and improve FDA's importation program under section 804 of the FD&C Act (the Section 804 Importation Program, or SIP) to make it easier for states to obtain FDA authorization of their plans to import drugs from Canada under the SIP without sacrificing safety or quality.
As we have discussed in prior Advisories,2 section 804 of the FD&C Act was enacted in 2003 and authorized FDA to issue regulations to allow for the importation of certain types of prescription drugs from Canada if the U.S. Department of Health and Human Services (HHS) certified to Congress that doing so would both result in a significant reduction in the cost of covered products to the American consumer and pose no additional risk to the public's health and safety. After many years of declining to make such a certification, HHS made the certification to Congress in September of 2020, and on October 1, 2020 FDA issued final regulations at 21 CFR Part 251 establishing the SIP.
Under the SIP, states and tribes can submit a SIP proposal to FDA, describing the state's or tribe's plan to import specific drugs from Canada in compliance with 21 CFR Part 251. If the state's or tribe's SIP proposal is authorized by FDA, the state or tribe may then proceed with importing the drugs from Canada under their authorized SIP plan and in compliance with the framework established by 21 CFR Part 251.3
The May 21 FDA Notice provides that:
- FDA will offer individual states and tribes the opportunity to submit a draft SIP proposal to FDA for pre-review, and to then meet with FDA to obtain the Agency's initial feedback on the draft proposal before the state or tribe formally submits its SIP proposal to FDA.
- FDA plans to develop a user-friendly tool that will help states develop a SIP proposal.
- FDA is working to assist states with options to streamline the cost savings analysis that SIP proposals are required to include, and to provide input to states regarding the information that states may rely on in developing that cost savings analysis.
- FDA anticipates meeting in the fall with states that have expressed interest in the SIP to discuss FDA ongoing efforts related to the SIP and to gather feedback from those states.
As of today, several states have submitted SIP proposals to FDA, although Florida's SIP plan is the only one that has been authorized by FDA. It does not appear, at least based on publicly available information, that any drugs have yet been imported under Florida's SIP.
Although the May 21 FDA.gov Notice does not contain many specifics, it indicates that FDA is trying to take a more active and supporting role in helping states develop and implement SIP proposals for potential authorization by FDA. Historically, the process for states to engage with FDA regarding their draft or submitted SIP proposals has been significantly more ad hoc than what is proposed in the May 21 FDA.gov Notice.
Footnotes
1 Please read Arnold & Porter's April 2025 Advisory for additional information regarding the executive order.
2 For example, see our October 2020 and January 2024 Advisories.
3 Although not discussed in detail in this Advisory, 21 CFR Part 251 establishes various requirements for importing drugs from Canada under an authorized SIP, such as prohibiting any import of drugs under the SIP plan without FDA first granting a pre-import request, and compliance with certain requirements relating to relabeling, supply chain security, and testing.
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