States, Tribes to Have Easier Time Importing Drugs From Canada
WASHINGTON — The Food and Drug Administration on Wednesday announced “enhancements” under section 804 of the Federal Food, Drug and Cosmetic Act to allow states and Indian tribes to more easily import certain prescription drugs from Canada.
The move, implementing an executive order signed by President Donald Trump, is intended to significantly reduce the cost of the drugs to U.S. consumers, without imposing additional risk to public health and safety, said FDA Commissioner Marty Makary in a written statement.
Going forward, the FDA will offer states and tribes the opportunity to submit a draft proposal for pre-review and meet with the agency prior to formally submitting their section 804 importation program 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 FDA said.
The agency is also in the process of developing a user-friendly tool that will assist states in developing their proposals.
Additionally, the FDA said it 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.
A series of meetings are planned for the fall to serve as a forum to exchange information that will make it easier for states to obtain authorization while protecting public safety, the agency said.
Dan can be reached at [email protected] and @DanMcCue
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