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# FDA Meets with States to Advance Canada Importation Plan
- URL: https://www.fdaweb.com/fda-meets-with-states-to-advance-canada-importation-plan/
- Published: 2026-03-09T12:00:00.000Z
- Updated: 2026-09-14T13:35:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160786

FDA says it recently held a meeting with several states to discuss implementation of a program that would allow the importation of certain lower-cost prescription drugs from Canada. The discussions focused on the Section 804 Importation Program, which permits states and Native American tribes to seek authorization to import specific medicines from Canada in an effort to lower costs for U.S. consumers.

The meeting was part of the agency’s efforts to implement a Trump administration executive order aimed at reducing drug prices, the agency said in a news release.

Officials from the U.S. Department of Health and Human Services and the National Academy for State Health Policy also took part in the session, which the agency said was designed to exchange information and help states move more easily through the authorization process while maintaining safety standards.

“We are committed to lowering prescription drug prices for Americans, building on recent MFN \[most favored nation\] wins,” said commissioner **Marty Makary**. He said the agency is working to help states and tribes import lower-cost medicines while protecting public health and safety.

Since the executive order was issued, FDA has invited states and tribes interested in the program to submit draft proposals for preliminary review and meet with agency officials before formally filing applications.

The agency said it is also helping potential applicants streamline the cost-savings analyses required for the proposals and advising them on the types of data they can use when estimating potential savings for consumers.

In January, the FDA launched a quality assurance tool designed to help program sponsors prepare importation proposals that comply with regulatory requirements. The tool includes guidance, lessons from earlier submissions and practical considerations for developing complete applications, the agency said.

Florida remains the only state authorized by FDA to import prescription drugs from Canada, but the long-promised program has yet to deliver any imported medicines more than two years after receiving final agency FDA approval ([see story](https://fdaweb.com/login.php?sa=v&aid=D5160586&cate=&stid=%241%24gl0.p6..%240bm.vDmKCEyCaNm0QryrJ1&ref=fdaweb.com)). The state’s Section 804 drug importation initiative, championed by Gov. **Ron DeSantis** as a way to lower prescription drug costs, has stalled amid resistance from Canadian drug manufacturers and regulators, ongoing logistical challenges, and mounting scrutiny over more than $82 million in state spending with no drugs imported to date, according to a *Politico* [report](https://www.politico.com/news/2026/02/02/desantis-florida-canada-drug-imports-00759891?ref=fdaweb.com).

resentation materials from the recent meeting have been posted [here](https://www.fda.gov/drugs/importation-program-under-section-804-fdc-act/section-804-importation-program-policies-and-authorizations?ref=fdaweb.com).