^®: CRE Regulatory Action of the Week

FDA Faces Anti-Counterfeiting Test
For almost 16 years the FDA has failed to implement a "valuable tool" Congress provided the agency to prevent counterfeit drugs from flooding the United States. The valuable tool is a law requiring that pharmaceuticals possess "pedigrees," paper trails documenting the chain of custody for drugs from the manufacturer to the pharmacy or other dispensing agent. A recent article in the Hartford Courant details the so far successful efforts by some pharmaceutical wholesalers and members of Congress to have FDA indefinitely delay implementation of the paper pedigree requirements despite the agency's "dire warnings about counterfeit prescription drugs..." Support for the pedigree requirements from manufacturers and others is discussed in the article as well as Florida's recent adoption of state pedigree law. The FDA pedigree requirements will go into effect April 1st unless the agency further delays the effective date of their Final Rule.