Anti-Counterfeit Drug Initiative Workshop and Vendor Display (Docket No. 2005N-0510)

The Food Marketing Institute (FMI) commends the Food and Drug Administration (FDA) on the Agency’s work and outreach with respect to implementation of the pedigree requirements of the Prescription Drug Marketing Act (PDMA) and respectfully submits the following comments in response to the Federal Register notice as well as the discussion at the recent public workshop that was held on the use of electronic track and trace technology to combat counterfeit drugs. 71 Fed. Reg. 1759 (Jan. 11, 2006). Our comments address the implementation challenges created by the PDMA as well as the solutions that are achievable through the use of electronic track and trace technology to combat counterfeit drugs. In addition, we are providing some suggestions regarding the application of the “authorized distributor of record” standard.