Will FDA’s Section 804 “Enhancements” Really Speed Up Drug Imports from Canada?

On May 21, FDA announced “enhancements” to the Section 804 import program (SIP).  Section 804 of the Federal Food, Drug, and Cosmetic Act provides a pathway for certain prescription drug imports from Canada. The FDA news release provides that FDA is offering to pre-review SIP proposals and meet with individual states and tribes to provide initial feedback on the proposal, with the goal of reducing burden on the state or tribe.  FDA also announced that it is working to develop a “user-friendly” tool to help states in developing proposals and that it will assist states with options to streamline the required cost savings analysis that must be included in such proposals.

The announcement comes a little over a month after President Trump’s April 15 Executive Order (EO), “Lowering Drug Prices by Once Again Putting Americans First.  That EO provided that within 90 days, “the Secretary, through the Commissioner of Food and Drugs, shall take steps to streamline and improve the Importation Program under section 804.”  Presumably, the enhancements noted in FDA’s news release are intended to meet this objective.

While creating a user friendly tool and developing options to streamline the cost savings analysis may assist with expediting state SIP proposal submissions, there are still several hurdles for states and tribes to get over before actually being able to import prescription drugs from Canada.  After the SIP proposal submission, FDA must first authorize the SIP proposal.  From there, the state/tribe must submit a Pre-Import Request to FDA within twelve months of the SIP authorization.  That Pre-Import Request, which requires extensive information, must be granted by FDA before imports can take place.

While we are aware of at least five states that have submitted SIP proposals to FDA, only one state, Florida, has received FDA authorization.  FDA authorized Florida’s SIP proposal in January 2024, three years after the SIP proposal had been submitted to FDA and after Florida filed a lawsuit over FDA’s failure to respond to Florida’s FOIA request for records regarding its proposal.  Despite being a motivated party, Florida still has not begun importing prescription drugs from Canada.  Shortly after the SIP was authorized,  we noted the significant hurdles that remained before Florida could begin to import.  In December 2024, FDA granted Florida a six-month extension to submit its Pre-Import Request.

The Florida case raises real questions about whether the actions announced today, even if they reduce  the timelines for SIP proposal submissions, will meaningfully impact the overall timeline for states to begin importing drugs from Canada.