statementofglaxosmithklineontheanti-counterfeitdrug.docVIP

Statement of GlaxoSmithKline on the Anti-Counterfeit Drug Initiative of the Food and Drug Administration Docket Number 2003N-0361 November 3, 2003 GlaxoSmithKline welcomes the opportunity to comment on FDA’s initiative on Drug Product Anti-Counterfeiting as well as the FDA Open meeting held on October 15, 2003. GSK is one of the world’s leading research-based pharmaceutical and biotechnology companies. Our company is devoted to inventing medicines that allow patients to lead longer, happier, healthier, and more productive lives. GSK is committed to doing its part to protect the integrity of the American drug supply so that pharmaceuticals patients receive meet the FDA-approved standards for safety, purity and potency. GSK believes that a closed distribution system is the best way to assure the integrity of the US pharmaceutical supply. A closed system may be defined as one where product is shipped directly from the manufacturer to the distributor and then on to the pharmacy and ultimately, the patient. Each business transaction in the supply chain would be recorded and a pedigree, ultimately tracing each lot back to the manufacturer would be maintained. Importation from within a manufacturer’s supply chain would be allowed and only reimportation under the rigorous definition of the Prescription Drug Marketing Act (PDMA) would be permitted. Unfortunately, the modest pedigree requirements promulgated by the FDA under the PDMA have been stayed twice for reasons unrelated to any public health considerations. In fact, it is safe to conclude that the reluctance to implement this regulation may contribute to some of the ease by which counterfeit drugs enter the marketplace. The estimated number of dispensing sites in the United States (approximately 80,000 by some estimates) means that the drug distribution system is complex. There are multiplicities of both licensed primary and secondary distributors. Secondary buying and selling of packaged pharmaceutica