FDA offering states help for Canada drug importation proposals

The U.S. FDA will offer feedback and other assistance to states that want to allow importation of prescription drugs from Canada before those states submit formal proposals.

The importation of medicines from Canada has long been seen as a way to reduce drug costs given how much cheaper most drugs costs there. Many websites offer the ability for Americans to already do so.

The FDA intends to work with states that are interested before they submit a section 804 proposal. Section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) allows importation of certain prescription drugs from Canada on the grounds of reducing costs for consumers without posing additional safety risks.

The FDA said that states and Indian tribes can submit draft proposal for pre-review. “The agency also will develop a user-friendly tool that will assist states in developing their proposals,” a news release states. “These actions will further clarify requirements and enhance the quality of proposals submitted to the agency, shortening the review timeline.”

The FDA will also assist states to streamline a necessary cost savings analysis.

In the fall, the agency expects to meet with states that are interested in the program “to exchange information that will make it easier for states to obtain authorization while protecting public safety.

The FDA’s announcement comes just nine days after President Trump signed an Executive Order to lower drug prices though the “Most Favored Nation” program that ties prescription drugs prices in the U.S. to the cheaper costs paid abroad.