Senators question proposed device approval changes

U.S. Senators Patti Murray (left) and Elizabeth Warren 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. “We strongly oppose the expansion of the conditional approval pathway to human drugs and devices, and we are seeking clarification on whether the FDA is pursuing this policy despite then-Commissioner Gottlieb’s commitments to the contrary,” the letter says. The FDA established the conditional approval pathway for animal drug development in 2004, allowing drugs for “minor species” or for “minor uses in a major species” to bypass the traditional FDA approval process without fully demonstrating their effectiveness. They have five years to meet the “substantial evidence” of effectiveness standard. In August 2018, the Animal Drug User Fee Act (ADUFA) further expanded the conditional approval pathway by creating a 10-year pilot program that allows other anim...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Featured Food & Drug Administration (FDA) News Well Regulatory/Compliance U.S. Senate Source Type: news