Improving the efficiency of the later stages of the drug development process : survey results from the industry, academia, and the FDA

Abstract

Drug development in the United States is a lengthy and expensive endeavor. It is estimated that average development times range from eleven to fifteen years and exceed costs of one billion dollars. The development pathway includes basic scientific discovery, pre-clinical testing in animals, clinical development in humans, and an application process. The Food and Drug Administration is responsible for the oversight and approval of drugs going through this process. Numerous financial and economic studies have been conducted that show the benefits to accelerating the drug development process. In 1992, the United States Congress enacted the Prescription Drug User Fee Act I, which mandated faster response times from the FDA in return for user fee payments to the FDA by the drug developing companies. Data on approval times for new drugs indicate that this process was indeed shortened. In contrast, the average drug development process prior to the filing of an application has been increasing in cost and time. The first purpose of this research is to quantify the benefits of accelerated new drug application review time under the Prescription Drug User Fee Acts I and II. The second purpose of the research is to investigate what industry and the FDA can do together to reduce the development process time between the IND and NDA without compromising patient safety and welfare, specifically the Phase II, Phase III, and NDA components. The research indicates that PDUFA has improved approval times in a statistically significant way. Furthermore, the financial and social benefits as measured using net present value have far exceeded the PDUFA costs. Quantitative and qualitative surveys of fifty individuals in large pharmaceutical and biotech companies

(cont.) resulted in the identification of several significant opportunities and useful suggestions for reducing development times in Phase II, Phase III, and the NDA. Specifically, company interviewees indicated that they were willing to pay additional monies for increased interaction and communication with the FDA from Phase II through the NDA in hopes of reducing information asymmetry and increasing information transparency. Other recommendations included a mandatory audit and review of a sample of NDAs post approval to identify best practices, implementation of metrics and performance tracking during clinical phases, and implementation of consistent project management and communication standards across therapeutic divisions.