Gaps within the drug distribution system make it increasingly vulnerable to bad actors, such as counterfeiters and terrorists. Congress intended the Prescription Drug Marketing Act (PDMA) of 1987 to close these gaps, but the PDMA has not fully succeeded. Important PDMA provisions that require tracking of drugs throughout the distribution chain in the form of "pedigrees" were set to be implemented as of Dec. 1, 2006, although a recent court order has stayed complete implementation. However, these PDMA requirements do not apply uniformly to all drug distributors in the United States. Moreover, since paper pedigrees can be forged, the pedigree system might not be sufficient to prevent the introduction of counterfeit drugs into the U.S. distribution system. Proposed bipartisan legislation in Congress, the Reducing Fraudulent and Imitation Drugs Act of 2006 (abbreviated hereinafter as "R.F.I.D. Act") addresses some of these concerns, but the legislation has not yet been enacted and it is unclear whether it will be. Thus, many loopholes remain in current FDA regulations.[...] This Note argues for immediate enactment of the R.F.I.D. Act or its equivalent (or alternatively, for Congress to amend the PDMA directly) to mandate the use of e-pedigrees by all distributors and manufacturers. This is not an impossible requirement to fulfill given the immediate availability of e-pedigree technology. The Note also encourages continued industry movement towards RFID as an e-pedigree solution, as well as implementation of the R.F.I.D. Act or its equivalent to protect consumer privacy. Part I of this Note discusses threats facing the U.S. drug supply from counterfeit drugs. Part II describes how counterfeits are introduced into U.S. drug supply chains. Part III discusses problems with the PDMA, and introduces the R.F.I.D. Act as a potential solution. Part IV describes use of RFID to secure the drug supply and current challenges facing its implementation. Part V discusses current use of barcodes within the pharmaceutical industry and the potential use of barcodes as a supplement to paper pedigrees.
The R.F.I.D. Act of 2006 and E-Pedigrees: Tackling the Problem of Counterfeit Drugs in the United States Wholesale Industry,
Mich. Telecomm. & Tech. L. Rev.
Available at: https://repository.law.umich.edu/mttlr/vol13/iss2/12