OTTAWA (dpa-AFX) - The U.S. Food and Drug Administration has announced 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 to American consumers.
FDA said it is taking this step 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 that President Donald Trump signed in April.
'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. '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.'
FDA said it will offer states and tribes the opportunity to submit a draft proposal for preview and meet with the agency to obtain initial feedback from it before submitting their section 804 importation program proposal, or SIP.
The agency also will develop a user-friendly tool that will assist states in developing their proposals.
FDA said it anticipates meeting with states that have expressed interest in the program to discuss these enhancements and gather feedback this Fall.
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