The Food and Drug Administration in recent weeks said it would decline to clarify laws that ban the foreign importation of prescription medicines, despite growing evidence of the overseas schemes.
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.”
