FDA Announces Updates to Pathway for Importing Prescription Drugs from Canada

The FDA has announced new enhancements to a pathway that allows states to “import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer.”

The agency will “offer individual states and tribes the opportunity to submit a draft proposal for pre-review and meet with the agency to obtain initial feedback from FDA prior to formally submitting their section 804 importation program (SIP) proposal. Meetings between individual states and the FDA will be optional and informal with the goal of reducing the burden on the state or tribe and helping it develop a robust SIP proposal.”

The agency will also “develop a user-friendly tool that will assist states in developing their proposals. These actions will further clarify requirements and enhance the quality of proposals submitted to the agency, shortening the review timeline.” The agency is also working to “assist states with options to streamline the required cost savings analysis, and to provide input regarding the information states may rely on as they estimate cost savings for American consumers.”

The agency will meet with states in the fall to “discuss these enhancements and gather feedback. This meeting will provide a forum to exchange information that will make it easier for states to obtain authorization while protecting public safety.”