FDA takes steps to enhance state medicines importation

22 May 2025

The US 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.

Yesterday, the agency 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 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 US, said FDA Commissioner Dr Marty Makary, noting that the 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.”

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