HHS Importation Study Advises Caution

01/13/2005

The recently released Report on Prescription Drug Importation (available in pdf format by clicking here), compiled by Health and Human Services’ importation task force, offers ample data and hard-boiled analysis to give industry, and consumers, food for thought in considering a more open system of personal and commercial drug importation. Clearly, HHS aims to err on the side of caution, and on the side of the status quo.

What follows are excerpts from the report’s executive summary of particular interest to pharmaceutical manufacturers, on costs, track and trace technologies, and FDA’s capabilities.

On the scope of the problem (p. IX):
“Nearly five million shipments . . . with a value of approximately $700 million entered the U.S. from Canada alone in 2003, via internet sales and travel to Canada by American consumers. This report estimates that an equivalent amount of prescription drugs are currently coming in from the rest of the world . . .

“The majority of these currently imported drugs are unapproved by FDA and do not appear to conform in many aspects to the properly approved and manufactured products available in American pharmacies.”

On resources (p. X):
“It would be extraordinarily difficult to ensure that drugs personally imported by individual consumers could meet the necessary standards for a certification of safety to be made. . . . A commercial importation system could be feasible but would require new legal authorities, substantial additional resources and significant restrictions on the type of drugs that could be imported, which could increase the cost of imported drugs.”

On technology (p. X):
“So-called ‘track and trace’ technologies, such as radio-frequency identification (RFID) and sophisticated bar coding, can provide effective monitoring . . . [but] until they are fully adopted internationally they cannot be adequately relied upon to secure the safety, efficacy, and integrity of the global market to safely import prescription drugs into the U.S.”

On FDA (p. XI):
“FDA currently does not have sufficient resources to ensure adequate inspection of current levels and categories of personal shipments of prescription drugs entering the U.S. . . FDA would need a meaningful investment . . . in new information technology and personnel, as well as appropriate standards to ensure adequate inspection of commercial quantities of drug products, if importation were legalized.”