Impediments to drug development.
There is a continual need for new products for wound care, as well as a desire by scientists and clinicians to translate information into wound healing improvements for patients. Pharmaceutical and biotechnology companies devote immense resources to fulfilling these needs and desires. However, there are many impediments to drug development that are poorly understood by caregivers, patients, and the public at large. Among these impediments are the tremendous costs involved, the short patent protection time, and regulatory issues. In addition, there is a marked attrition of potential drugs as they progress through the various stages of development. When the costs, time, regulatory issues, and attrition impediments are overcome, the problems with reimbursement become an impediment. This is especially true in the elderly population in which most chronic wound healing problems occur. Finally, academic societies such as the Wound Healing Society and its members pose an impediment to drug development. There is a need to interact with various governmental agencies and industry to facilitate translating science to patient care. This has not been done with a strong, uniform voice. These are but a few of the impediments that prevent scientific advances from resulting in new products available at the bedside to improve the quality of life of our patients.
Robson
Martin C
MC
Institute of Tissue Regeneration, Repair, and Rehabilitation, Bay Pines, and the Department of Surgery, University of South Florida, Tampa, Florida, USA. mcrobson@earthlink.net
D001709:Biotechnology; D002986:Clinical Trials as Topic; D016527:Drug Costs; D015195:Drug Design; D004345:Drug Industry / Q000191:economics; D006801:Humans; D007880:Legislation, Drug; D012051:Reimbursement Mechanisms; D012955:Societies, Medical; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration; D014945:Wound Healing / Q000187:drug effects*