Chapter 17: Information Technology FDA Compliance in the Pharmaceutical Industry

Raymond Papp, University of Tampa

USA

EXECUTIVE SUMMARY

Given the recent profitability of and demand for pharmaceuticals, from prescription antibiotics and analgesics like Ciproflaxin™ and OxyContin™ and men's health drugs such as Viagra™ and Vardenafil™ to over-the-counter Senokot™ laxatives and Betadine™ antiseptics, the rush to develop and market new pharmaceuticals has never been greater. The current process is complex and it often takes several years for a drug to reach the market due to the myriad of Food and Drug Administration (FDA) guidelines. Furthermore, the recent FDA guidelines mandating that all New Drug Applications (NDA) be submitted in electronic (paperless) format by the end of 2002 is a catalyst for change in the pharmaceutical industry (FDA Proposes First Requirement for Electronic Submission, 2002; New Drug Application (NDA), 2001). Bayer Pharmaceutical, like its competitors Purdue Pharma and Boots Healthcare, has begun to take steps to assure that its use of information technology will allow it to not only meet FDA guidelines, but achieve its corporate goals of improved efficiency and reduced operating costs.