The Food and Drug Administration (FDA) announced Wednesday plans to help states and Indian tribes import cheaper prescription drugs from Canada.
The initiative is in support of President Donald Trump’s executive order on May 12 which promised to deliver “most-favored nation prescription drug pricing” to America, which the president predicted would lower drug costs by 59 percent or more.
The FDA will meet with states looking to apply for a waiver which allows them to import drugs under Section 804 of the Federal Food, Drug and Cosmetic Act (FD&C).
Under the current law, states must submit a draft proposal called a Section 804 Importation Program (SIP) proposal. Now, the FDA will help states craft these proposals before they submit them, helping to streamline the process, the agency said in a press release.
The agency will also be developing a “user-friendly tool” to help states build their proposals. (RELATED: Trump Admin Pulls Back From COVID Boosters For All Americans, Demands More Evidence)
Currently, a petitioning state must “demonstrate that their importation program will result in a significant reduction in the cost of eligible prescription drugs to the American consumer without posing any additional risk to the public’s health and safety,” according to the FDA.
Today, the FDA 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,… pic.twitter.com/Av1uaVBJRU
— U.S. FDA (@US_FDA) May 21, 2025
“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,” FDA Commissioner Dr. Marty Makary said in a statement. (RELATED: Dems Who Clapped Like Seals For Biden’s Big Pharma Actions Do 180 On Trump Drug Pricing Order)
“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,” Makary concluded.
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