FDA declines to issue specific guidance on drug importation by AFPs
U.S. Food and Drug Administration headquarters in Silver Spring, Maryland, November 4, 2009.
Jason Reed | Reuters
The Food and Drug Administration has said in recent weeks that it will refuse to clarify laws banning imports of prescription drugs from abroad, despite growing evidence of overseas programs.
One class of businesses, called alternative financing programs, or AFPs, connect patients whose health plans don’t cover expensive drugs for critical illnesses with more affordable versions of drugs. The programs take drugs from foreign markets that U.S. regulators say is a violation of import laws.
FDA last month responded to a March 2024 citizen petition from Aimed Alliance, a nonprofit health policy organization, asking the agency to issue a definitive position on AFPs and the use of international imports to save on drug costs.
Specifically, the alliance called for the FDA to issue a “guidance document” targeting AFPs that import drugs from abroad; this would further clarify the agency’s policy and potentially eliminate some gray areas in interpreting the law.
In its March 27 letter, the FDA said it shared the Alliance’s concerns and acknowledged that “drugs that evade regulatory measures may be contaminated, counterfeit, or contain completely varying amounts of active ingredients.”
But he rejected the group’s request for a clear position statement and specific guidance on AFPs, saying “this is not allowed at this time”. The agency said issuing this guidance “would not be an efficient use of the FDA’s limited resources.”
“We take complaints seriously and appreciate the information you provide. However, to the extent you are asking FDA to take enforcement action, such actions are not within FDA’s civil petition procedures,” the letter said.
The letter was signed by Michael Davis, deputy director of the FDA’s Center for Drug Evaluation and Research.
Aimed Alliance is one of several patient advocacy groups asking the FDA to crack down on AFPs that use foreign sources to import drugs. The alliance did not immediately respond to CNBC’s request for comment.
A CNBC investigation in November found that AFPs are becoming more common across the country. As part of that investigation, an official with Homeland Security Investigations said AFP’s practices were illegal, while program operators maintain they did not violate the law and helped patients obtain critical medications at little or no cost.
