President OKs Incentive for Pediatric Drug Development
President Obama on Monday signed into law the Food and Drug Administration Safety and Innovation Act that includes provisions by U.S. Rep. Michael McCaul to offer incentives to drug companies to develop treatments for rare childhood diseases and pediatric cancers.
The White House released a statement announcing Obama's action.
"Today is a milestone for children who suffer from cancer and other rare pediatric diseases," said McCaul, founder and chairman of bipartisan Congressional Childhood Cancer Caucus. "This law will help pharmaceutical companies overcome market failures and change the way they look at developing treatments for children who currently don't have any, or don't have treatment specific to their disease."
White House press secretary Jay Carney said the legislation would increase the ability of the FDA to "provide timely and expedited review and approval of applications for prescription drugs and medical devices."
The law allows the FDA to provide vouchers to drug manufacturers so they can obtain speedier approval for profit-making medications in return for developing drugs for the small and unprofitable market of rare childhood diseases.
Congress estimates that participating drug manufacturers can gain up to $500 million in additional sales on patent-protected medications by taking advantage of expedited FDA review that can cut the approval process from an average of 10 months to six.