The U.S. Food and Drug Administration is continuing to take steps to help state importation programs provide safe, effective and more affordable drugs for American patients, as part of its efforts to implement Executive Order Lowering Drug Prices by Once Again Putting Americans First. Today, the agency is announcing enhancements to the pathway under section 804 of the Federal Food, Drug and Cosmetic Act that allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer, without imposing additional risk to public health and safety.

“For too long, Americans have been getting taken advantage of. Drug prices in the U.S. are sometimes 5-10 times higher than in wealthy European countries. “ said FDA Commissioner Marty Makary, M.D., M.P.H. “Today’s actions will support the ability to import drugs at much  lower prices  while also maintaining the high quality and safety of medicines that Americans expect and deserve.”

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 also will 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.  

Additionally, the agency is 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.

This fall, the agency anticipates meeting with states that have expressed interest in the program 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.