U.S. Food and Drug Administration Headquarters, Silver Spring, Maryland, November 4, 2009.
Jason Reid | Reuters
The Food and Drug Administration announced in recent weeks that it would decline to clarify the law banning the importation of prescription drugs overseas, despite mounting evidence of a conspiracy abroad.
A group of companies called Alternative Funding Programs (AFP) connects patients whose health insurance doesn’t cover expensive drugs for serious illnesses with more affordable drugs. The program obtains medicines from foreign markets, which U.S. regulators say violates import laws.
Last month, the FDA responded to a March 2024 public petition from the Aimed Alliance, a nonprofit health policy organization, asking the agency to issue a final opinion on AFP and the use of international imports to save on drug costs.
Specifically, the alliance asked the FDA to issue a “guidance document” for AFPs that import pharmaceutical products from overseas. This could further clarify FDA policy and eliminate gray areas in interpreting the law.
In a March 27 letter, the FDA said it shared the alliance’s concerns and acknowledged that “drugs that circumvent regulatory safeguards may be contaminated, counterfeit, or contain different amounts of active ingredients.”
But the group rejected its request for a clear position statement and concrete guidance on AFP, saying it was “unwarranted at this time.” The agency said issuing that guidance “is not an efficient use of FDA’s limited resources.”
“We take complaints seriously and appreciate the information you provide. However, to the extent that you are asking FDA to initiate enforcement action, such action is not within the scope of FDA’s public petition process,” the letter reads.
The letter was signed by Michael Davis, deputy director of the FDA’s Center for Drug Evaluation and Research.
The Aimed Alliance is one of several patient advocacy groups asking the FDA to crack down on AFP’s use of foreign sources to import medicines. The alliance did not immediately respond to a request for comment from CNBC.
A CNBC survey in November found a sharp increase in AFP across the United States. As part of that investigation, Homeland Security Investigations officials said AFP’s actions were illegal, but program operators maintain they are not breaking any laws and are helping patients obtain critical medicines at little or no cost.
