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ALEXANDRIA, Va. — A federal report on the rise of counterfeit drugs drew comment this week from the National Association of Chain Drug Stores, which welcomes the government’s efforts to tackle the issue but opposes the mandate for a national track-and-trace system.
NACDS said Thursday that the report, "Counterfeit Pharmaceutical Interagency Working Group Report to the Vice President of the United States and to Congress," was prepared by the Office of Intellectual Property Enforcement Coordinator (IPEC); Food and Drug Administration; U.S. Customs and Border Protection; U.S. Immigration and Customs Enforcement; the departments of Justice, State and Commerce; and the Agency for International Development on counterfeit pharmaceuticals.
The report discusses a number of issues and efforts to combat counterfeit drugs, including importation, ports of entry, international law enforcement efforts and partnerships, international public awareness campaigns, according to the association.
NACDS applauded government efforts to raise public awareness about fake drugs, illicit online drug sellers and drug safety, as well as initiatives and policies to crack down on such illegal activity.
"The report recognizes that there are thousands of illegal web sites that sell unapproved or counterfeit drugs without a valid prescription, which pose a threat to patient health," NACDS president and chief executive officer Steve Anderson said in a statement. "We also welcome the report’s support for the private-sector initiative that would share information on the illicit web sites, fund educational campaigns, establish a list of legitimate online pharmacies and share information with law enforcement.
"NACDS has been engaged in federal and state policy initiatives to further safeguard the supply chain. The association advocated for legislation enacted in 2008 that cracks down on rogue online pharmacies and distinguishes between such sites and legitimate sites operated by licensed pharmacies," he explained. "NACDS also helped to enact state legislation that strengthened wholesale distributor licensure requirements and increased penalties for intentional distribution of counterfeit drugs."
However, Anderson noted, NACDS believes a solution calling for a track-and-trace system wouldn’t be effective at this time and would be too expensive for pharmacies and others in the pharmaceutical supply chain.
"NACDS does not support the report’s proposal to mandate a track-and-trace system in the U.S.," he stated. "The operational processes surrounding a mandated track-and-trace system are still under development and cannot achieve their desired purpose at this time, which will prove extraordinarily costly for pharmacies and other supply chain operators."
Anderson added, "Following the release of this report, we look forward to working with FDA as it provides recommendations on next steps for preserving the integrity of the pharmaceutical supply chain."
