“I am delighted to say that Congress has passed legislation reauthorizing the four user fee programs that provide critical funding to the FDA for its human medical products activities,” FDA Commissioner Dr. Robert Califf said on Twitter.
He later tweeted: “It means that we will not need to begin the notification process for user fee-funded staff.”
The reauthorization generally maintains the existing fee structure, but it includes a new mechanism where the FDA will be able to increase fees in later years if it meets goals related to timely review of submissions.
Trade group AdvaMed also applauded the passage of the fifth iteration of the Medical Device User Fee Amendment (MDUFA V).
“The bipartisan passage of this historic five-year agreement sets the stage for a new era of innovation in health care, ensuring greater predictability, consistency, accountability, and communication between FDA and the medtech innovators who are changing the way patients seek and receive life-saving care. We are in a golden age of medical technology innovation, and the improvements made by MDUFA V will serve as a catalyst for even greater health care transformations,” AdvaMed CEO Scott Whitaker said in a news release.
Said Medical Device Manufacturers Association CEO Mark Leahey said: “While more work needs to be done to strengthen our nation’s leadership in medical technology innovation, this legislation represents a significant investment in the MDUFA program, and MDMA remains confident that FDA will effectively leverage the additional resources to accelerate patient access to safe and effective medical technologies.”
The reauthorization that passed left out additional proposals from the Senate. Said Califf: “While the user fee reauthorization package passed by Congress did not include additional policy changes that we believe would benefit public health, we remain committed to working with Congress on these policies.”