The Food and Drug Administration (FDA), citing a gap between investment in pharmaceutical research and new drug approvals, announced plans Tuesday (March 16) to reform the regulatory path to therapy development.
The plans represent the agency's attempt to reduce the cost of developing drugs by using new diagnostic and imaging technologies to better design clinical trials. “We're not seeing the increases in new products that we expected based on all the advances in science,” said Janet Woodcock, the FDA's director of cross-center initiatives. “The professional staff at the agency is also concerned about how the new scientific knowledge is going to be worked up to apply to product development.”
The FDA estimates that a new drug costs from $800,000 to $1.7 billion to bring to market, but most drugs do not work on most people, Woodcock told