FDA Commits to Taking Action Against Programs that Import or Offer to Import Illegal Prescription Drugs and Products


At the end of February 2023, Aimed Alliance sent a letter to the Food and Drug Administration (FDA) Office of Regulatory Affairs and Office of Importation Operations, arguing that alternative funding programs were illegally importing prescription drugs from outside the United States and jeopardizing the health and safety of consumers in the United States. Our letter specifically alleged that these programs violate the Food, Drug, and Cosmetic Act (FDCA), the FDA’s guidance on personal importation and the final rule on Section 804 drug importation from Canada.

FDA’s Response
On April 14, 2023, the FDA sent a response to Aimed Alliance’s February 2023 letter. In the letter FDA stated it was concerned regarding the risk of unapproved drugs and misbranded drugs being imported from outside the US.

FDA also stated: “We will continue to use our resources to find and take action against those companies that import or offer [to]import illegal products.” Read FDA’ Response to Aimed Alliance here.

Want to Learn More About Alternative Funding Programs?

Check out these recent resources from Aimed Alliance on alternative funding and non-EHB programs:

Non-EHB Fact Sheet
Alternative Funding Program Fact Sheet
Infographic on Alternative Funding Programs 
Comment to FTC
Letter to FDA 

Visit the Copay Accumulator 101 Hub to learn more.

Last Updated on April 19, 2023 by Aimed Alliance


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