House panel advances user fee bill

A U.S. House panel yesterday advanced the Lower Chamber’s version of the bill to reauthorize the user fee deal between the medical device and drug industries and the FDA. Medical device and drug companies pay user fees to have the FDA review their products. The last Medical Device User Fee Act in 2012 doubled user fees from $295 million over 5 years to $595 million, in exchange for performance goals set for the FDA. Although the parties hammered out the 4th MDUFA iteration last August, earlier this year the Trump administration proposed doubling the fees to $2 billion for calendar 2018. In return, the Trump budget would contain “a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products.” The bill, 1st floated April 14 by the House Energy, Labor & Pensions and the Senate Energy & Commerce committees, would increase to total user fee program to $1.17 billion for fiscal 2017, which begins Oct. 1, adding about $400 million. Yesterday the House committee approved a markup version, adding amendments on medical device servicing, the review process for imaging techniques that use contrast agents; a process for reclassifying medical device accessories; a voluntary pilot program on medical device safety and effectiveness; and a provision seeking to lower prescription drug prices. The House markup version, which now advances to the full chamber, also included technical correct...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Wall Street Beat Capitol Hill User fees Source Type: news