FDA launching innovation plan

FDA Commissioner Scott Gottlieb said Wednesday the agency is launching a Medical Innovation Access Plan designed to facilitate biomedical innovation. Speaking to the Senate Appropriations Committee’s subcommittee on agriculture, rural development and FDA, Gottlieb positioned the plan as a tool to lower healthcare costs by reducing expenditures on costly diseases. “Ultimately, the most tangible way we’re going to reduce healthcare costs is by finding new and better treatments for vexing diseases like diabetes and cancer and neurodegenerative ailments like Alzheimer’s,” Gottlieb said.

He also suggested that the initiative could lead to lower drug prices by reducing regulatory uncertainty and eliminating unnecessary regulatory costs. Drugs, Gottlieb said, “are priced to some measure of the cost of the capital -- including the investment capital -- that’s required to discover and develop them. And the risk and time and cost of the regulatory process are a big part of that equation.”...