health
FDA Declines to Issue Specific Guidance on Health Programs' Foreign Drug Imports
A CNBC investigation revealed the proliferation of AFPs, which import prescription drugs from overseas in what U.S. regulators say is a violation of import laws.
TL;DR
- The FDA will not clarify laws banning foreign importation of prescription medicines.
- Alternative funding programs (AFPs) connect patients with affordable foreign versions of expensive drugs.
- The FDA considers these AFP practices a violation of import laws.
- Aimed Alliance requested the FDA issue a guidance document clarifying policy on AFPs.
- The FDA cited concerns about potentially contaminated or counterfeit drugs but denied the request, deeming it not warranted and an inefficient use of resources.
- A previous CNBC investigation highlighted the growth of AFPs, with a Homeland Security Investigations official calling the practices illegal, while program operators dispute this.