FDA declines to issue specific guidance on health programs’ foreign drug imports

A class of businesses called alternative funding programs, or AFPs, connect patients whose health plans don’t cover expensive medications for critical diseases with more affordable versions of the drugs. The programs obtain the medications from foreign markets in what U.S. regulators say is a violation of import laws.

The FDA last month responded to a March 2024 citizen petition from Aimed Alliance, a non-profit health policy organization, that requested the agency to issue a definitive position on AFPs and the use of international importation to save on drug costs.

Specifically, the Alliance wanted the FDA to issue a “guidance document” aimed at AFPs that import drugs from overseas, which would have further clarified the agency’s policy and potentially eliminated some gray area in the interpretation of the laws.

In the letter, dated March 27, the FDA said it shared the Alliance’s concerns and acknowledged drugs that have “circumvented regulatory safeguards may be contaminated, counterfeit, or contain varying amounts of active ingredients altogether.”

But it denied the group’s request for a clear position statement and specific guidance about AFPs, saying that “it’s not warranted at this time.” The agency said “it would not be an efficient use of FDA’s limited resources” to issue that guidance.

“We take complaints seriously and appreciate the information that you have provided. However, to the extent you are asking FDA to initiate an enforcement action, such actions are not within the scope of FDA’s citizen petition procedures,” the letter said.

The letter was signed by Michael Davis, deputy director for the FDA’s Center for Drug Evaluation and Research.

Aimed Alliance is one of several patient advocacy groups that have asked the FDA to crack down on AFPs using foreign sources to import medications. The Alliance did not immediately respond to a request for comment from CNBC.

A CNBC investigation in November revealed the proliferation of AFPs across the country. As part of that investigation, a Homeland Security Investigations official said AFP practices were illegal, while the program operators maintain they are not breaking the law and help patients obtain critical drugs for little or no cost.