Gottlieb Speaks to RAPS Regulatory Conference

United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently spoke with attendees of the Regulatory Affairs Professionals Society (RAPS) Regulatory Convergence conference about the steps the FDA is taking to make the clinical end of drug development more efficient and effective. Gottlieb started by speaking and providing an overview of the history of medicine, all the way back to the “germ theory,” first proposed by Girolamo Fracastoro in 1546 through the late 1850s when Louis Pasteur and Robert Koch offered convincing evidence that germs caused disease and the 1870s, when sanitation was finally used in the medical field. Gottlieb goes on to note that there is always a period between when the discovery of “a central principle of biological science” is discovered, to its eventual translation into the tools of clinical medicine. He notes that as science continues to evolve, that time period in shrinking and that primary ideas are more quickly reshaping the way we approach illnesses. Gottlieb stated that the cost of drug development is on “an unsustainable path, where the cost of drug development is growing enormously, as well as the costs of the new medicines.” He also noted his belief that something needs to be done now, to make the whole process less costly – and more efficient – recognizing that if nothing is done, “we won’t continue to realize the practical benefits of advances in science, and in the form of new and better med...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs