ABSTRACT
Drug development is expensive, time-consuming and very risky. From first discovery to launch and commercialization the process takes from 10 to 15 years of pre-clinical and clinical testing. The Research and Development investment cost for new drugs is much debated, at least in part because the drug industry frequently defends high drug prices over the need to make significant investments in new drug development. US politicians have called for transparency through mandatory disclosure of pharmaceutical company financials, particularly in relation to annual price increases. Traditionally, clinical trials are designed to meet the requirements set by the Food and Drug Administration and equivalent non-US regulatory agencies, such as the European Medicines Agency for Europe, to demonstrate efficacy and safety in the treatment for the indication that is sought for approval. The “Implementation and Adjustment” stage extends from the start of access negotiations through the rest of the drug’s life cycle, including competitive adjustments and generic defense strategies.
