Skip to Content
    Call Our 24/7 Helpline 800.272.3900

    Statement of Support for FDA’s Accelerated Approval Pathway

    Statement of Support for FDA’s Accelerated Approval Pathway

     
    March 16, 2022
     
    The Honorable Frank Pallone
    House Energy & Commerce Committee
    Cannon House Office Building
    Washington, D.C. 20515
    The Honorable Cathy McMorris Rodgers
    House Energy & Commerce Committee 237
    1035 Longworth House Office Building
    Washington, D.C. 20515
     
    The Honorable Patty Murray
    Senate Committee on Health, Education, Labor and Pensions
    428 Dirksen Senate Office Building
    Washington, D.C. 20510
    The Honorable Richard Burr
    Senate Committee on Health, Education, Labor and Pensions
    428 Dirksen Senate Office Building
    Washington, D.C. 20510

    Dear Chairman Pallone, Ranking Member McMorris Rodgers, Chairman Murray and Ranking Member Burr:

    We write today to convey our strong support for FDA’s Accelerated Approval pathway and to convey to Congress the importance of preserving and strengthening this critical tool for bringing therapies to patients currently living with unmet medical need. At each turn when Congress has legislated on accelerated approval the pathway has been reaffirmed and the Agency has been encouraged to fully harness the promise of the pathway on behalf of patients. Lives have been saved, extended and improved.

    Millions of American families are grateful for these past actions by Congress and fully expect this Congress to continue to support and encourage the use of accelerated approval for all of the patients who today live with unmet medical needs. Who are these patients? They are Americans living with rare diseases, 95% of which currently have no approved treatments. They are Americans living with conditions like Alzheimer’s where treatments are just beginning to emerge but the unmet need remains vast or diabetes where treatments have emerged but there are still unmet needs in disease modifying therapies to address the underlying autoimmunity in type 1 diabetes. They are Americans, many of whom are children, whose disease progression means that the loss of certain core functions and mobility cannot be recovered if novel therapies take too long to clear the regulatory process. They are Americans for whom a curative treatment is on the horizon through game changing cell and gene therapies. And the list goes on.

    As you begin consideration of the FDA User Fee reauthorization the undersigned organizations and our broader community of patients and families wants to be clear about our unequivocal support for preserving the accelerated approval pathway and ensuring that all patients living with unmet need, regardless of their specific condition, can continue to have confidence in the FDA’s utilization of the pathway.

    We stand ready to support any effort you may undertake to reaffirm Congress’ ongoing support for accelerated approval. Just as we stand ready to support those efforts, we also stand ready to defend the pathway against any efforts that would intentionally or unintentionally limit FDA’s ability to utilize the pathway or any efforts that would essentially undermine the use of or confidence in the pathway. HIV went from a death sentence to a chronic disease because of accelerated approval. Many cancers have been beaten back due to accelerated approval. It is only reasonable to continue to offer that same hope and deliver on the same results for the millions of patients still living with unmet need.

    Sincerely,
    Robert Egge
    Chief Public Policy Officer, Alzheimer’s Association
    Executive Vice President, Alzheimer’s Impact Movement
    Cynthia Rice
    Chief Mission Strategy Officer, JDRF

    cc:
    Rep. Bobby Rush
    Rep. Tom O’Halleran
    Rep. John Curtis
    Rep. Anna Eshoo
    Rep. Kathleen Rice
    Rep. Debbie Lesko
    Rep. Diana DeGette
    Rep. Angie Craig
    Rep. Greg Pence
    Rep. Michael Doyle
    Rep. Kim Schier
    Rep. Dan Crenshaw
    Rep. Janice Schakowsky
    Rep. Lori Trahan
    Rep. John Joyce
    Rep. G.K. Butterfield
    Rep. Lizzie Fletcher
    Rep. Kelly Armstrong
    Rep. Doris Matsui
    Rep. Fred Upton
    Rep. Kathy Castor
    Rep. Michael Burgess
    Rep. John Sarbanes
    Rep. Steve Scalise
    Rep. Jerry McNerney
    Rep. Robert Latta
    Rep. Peter Welch
    Rep. Brett Guthrie
    Rep. Paul Tonko
    Rep. David McKinley
    Rep. Yvette Clarke
    Rep. Adam Kinzinger
    Rep. Kurt Schrader
    Rep. Morgan Griffith Rep. Tony Cardenas
    Rep. Gus Bilirakis
    Rep. Paul Ruiz
    Rep. Bill Johnson
    Rep. Debbie Dingell
    Rep. Scott Peters
    Rep. Billy Long
    Rep. Larry Bucshon
    Rep. Marc Veasey
    Rep. Markwayne Mullin
    Rep. Ann Kuster
    Rep. Richard Hudson
    Rep. Robin Kelly
    Rep. Tim Walberg
    Rep. Nanette Diaz Barragan
    Rep. Earl Carter
    Rep. Donald McEachin
    Rep. Jeff Duncan
    Rep. Lisa Blunt Rochester
    Rep. Gary Palmer
    Rep. Darren Soto
    Rep. Neal Dunn
    Senator Bernie Sanders
    Senator Rand Paul, M.D.
    Senator Robert Casey
    Senator Susan Collins
    Senator Tammy Baldwin
    Senator Bill Cassidy, M.D.
    Senator Christopher Murphy
    Senator Lisa Murkowski
    Senator Tim Kaine
    Senator Mike Braun
    Senator Maggie Hassan
    Senator Rodger Marshall, M.D.
    Senator Tina Smith
    Senator Tim Scott
    Senator Jacky Rosen
    Senator Mitt Romney
    Senator Ben Ray Lujan
    Senator Tommy Tuberville
    Senator John Hickenlooper
    Senator Jerry Moran