NACDS Comments on Newly-Released Report on Pharmaceutical Supply Chain Integrity

Alexandria, Va. - The National Association of Chain Drug Stores (NACDS) today commented on a report prepared by the Office of Intellectual Property Enforcement Coordinator (IPEC), the Food and Drug Administration (FDA), U.S. Customs and Border Protection, U.S. Immigration and Customs Enforcement, the Departments of Justice, State, 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, and others.

NACDS President and CEO Steven C. Anderson, IOM, CAE issued the following statement:

"Pharmacy is committed to providing patients with safe and high-quality medication. We share the goal of improving the public awareness of the risks posed from counterfeit drugs and illicit online drug sellers.

"The report recognizes that there are thousands of illegal websites that sell unapproved or counterfeit drugs without a valid prescription, which pose a threat to patient health. We also welcome the report's support for the private sector initiative that would share information on the illicit websites, 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. NACDS also helped to enact state legislation that strengthened wholesale distributor licensure requirements and increased penalties for intentional distribution of counterfeit drugs.

"NACDS does not support the report's proposal to mandate a ‘track and trace' system in the U.S. 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.

"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."