U.S. Senators Patti Murray (D-Wash.) and Elizabeth Warren (D-Mass.) are challenging an FDA budget proposal that would ease the approval process for certain medical devices.
In a June 24 letter to Acting Commissioner Dr. Ned Sharpless and Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health, Murray and Warren target the “progressive approval for devices” program included in the agency’s fiscal year 2020 budget that would expand the conditional approval pathway for animal drugs to human medical products. Former FDA Commissioner Scott Gottlieb had “assured us” this expansion would not take place, the senators wrote.