White Papers for Food and Drug Administration (FDA)

Not as Easy as It May Appear Using RFID to Fulfill PDMA's Elusive Pedigree Requirement

Harvard Law School

In the most recent stay of the final rule implementing the pedigree requirement of the Prescription Drug Marketing Act (PDMA), the Food and Drug Administration (FDA) recommended that the drug wholesaler industry voluntarily adopt Radio Frequency IDentification Technology (RFID) to fulfill the pedigree requirement of the Act. In so doing, FDA expressed a desire to exert minimal regulatory oversight over the implementation of this technology. This paper reviews the potential regulatory and policy implications of using this technology to satisfy the pedigree requirement of the Prescription Drug Marketing Act and explores whether it is likely that the electronic pedigree generated using RFID technology will be the talisman that will address the concerns of industry while fulfilling the purposes of PDMA

View the White Paper

Share or bookmarklet this web page at: