While importation proposals are intended to "make lower-cost but genuine, safe and effective drugs available to U.S. consumers," in practice they would "harm patients and consumers and compromise the carefully constructed system that guards the safety of our nation’s medical products," the former commissioners wrote in an open letter to Congress. Robert Califf, Margaret Hamburg, Mark McClellan, and Andrew von Eschenbach signed the letter.
The former commissioners note that in exceptional circumstances, limited importation has been permitted, but wrote that when they were in office, none of them was "able to conclude that a wider policy of routine importation would increase access to safe and effective drugs for the American public."
The letter directly addresses legislation that seeks to assure the safety of imported drugs by limiting importation to drugs made in FDA-inspected plants. "Allowing importation of drugs purported to be manufactured overseas in FDA-inspected facilities and drugs purported to be manufactured domestically for export to other countries and re-imported from those countries to the United States can not meet the requirements under the existing closed drug manufacturing and distribution system because the drugs could not be tracked and certified by the manufacturer."
Sales of illicit, ineffective, or adulterated products are a lucrative business for organized crime, the letter warns. It would be practically impossible to screen and verify the authenticity of massive quantities of imports, the group wrote, adding that "if spot-checking discovered a dangerous or counterfeit product, in the absence of the closed system currently in use, there would be no way to trace that product to its origin or intervene to protect other consumers before irreparable harm occurs."
The letter also challenges assumptions about cost savings from importation, noting that drugs are allotted to countries based on the needs of their populations, leaving little extra inventory for export to the U.S. It states that importation "would likely have only a small, incremental effect on cost and access for drugs in the U.S. market; further, these small savings might not be passed on to patients, even if consumers are able to obtain a legitimate imported drug."
The letter concludes: "We urge Congress and the many others concerned about the cost of drugs to deal directly with the issues driving the cost of medicines and not to place false hope in measures that will place patients who need treatment at risk and jeopardize public health.