U.S. Senate Hearing on Promising Pathways Act FDA Reform

On Thursday, Oct 26, the U.S. Senate Committee on Aging hearing on “Unlocking Hope: Access to Therapies for People with Rare, Progressive, and Serious Diseases” heard witnesses offer support of the bipartisan Promising Pathway Act (PPA), S-1906, H.R. 4408, to reform the Food and Drug Administration.

The sponsors are Senators Mike Braun (R-IN), Kirsten Gillibrand (D-NY), Lisa Murkowski (R-AK), Kevin Cramer (R-ND) and Roger Wicker (R-MS). House members who support the effort include Representatives Mike Gallagher (R-WI), Mike Quigley (D-IL), Bruce Westerman (R-AR), and Eric Swalwell (D-CA).

The hearing was proceeded by a press conference which featured patients unable to access promising, lifesaving treatments and parents who lost children because FDA red tape.

Despite recent FDA reforms, it takes 10-12 years at a cost of some $3 billion to bring new treatments from research lab to patients, much of that time and cost because FDA’s antiquated certification requirements. Among its benefits sought by PPA are:

  • ·Allow for provisional approval of treatments that have been tested as safe but are still in clinical trials, which will allow those suffering from serious ailments but who can’t get into those trials access to health- and life-saving medicines;
  • ·Require real world data on patient experiences with experimental treatments to be logged in a data base which would allow the sponsors to secure quicker approval for beneficial treatments and would alert healthcare providers to promising treatments that could help their patients;
  • ·Open the door for innovative ways to test proposed treatments, cutting costs and approval time, and spurring the development of innovative treatments.

If you are interested in saving lives, reducing misery and costs, and replacing our current “sickcare” system with a true healthcare system, you should explore this approach to increasing patient access to needed treatments; publicize this PPA effort; and contact the bill’s sponsors—see list below—and your own legislators about the important benefits of this reform,

This is an opportunity make a real difference, to be part of a healthspan and longevity.

You can contact me with any questions and thoughts at [email protected]

Edward Hudgins, Ph.D.
Human Achievement Alliance, Inc.
12 Scandia Way, Rockville, Maryland 20850

Contact information

Sen. Mike Braun (R-IN)
404 Russell Senate Office Building
Washington, DC 20510
(202) 224-4814

Staff: Jacob Chebowski

[email protected]

Kirsten Gillibrand (D-NY)
478 Russell Senate Office Building
Washington, DC 20510
(202) 224-4451
[email protected]

Lisa Murkowski (R-AK)

522 Hart Senate Office Building
Washington, DC 20510
Staff: Kaleb Froehlich

[email protected]

Kevin Cramer (R-ND)
313 Hart Office Building
Washington, DC 20510
(202) 224-204
Staff: Ryan Kenyon
[email protected]

Roger Wicker (R-MS)
425 Russell Senate Office Building
Washington, DC 20510
(202) 224-6253
Staff: Phillip Waller

[email protected]

Rep. Mike Gallagher (R-WI)
1211 Longworth HOB

Washington, DC  20515

Phone: (202) 225-5665

Reps. Mike Quigley (D-IL)
2083 Rayburn HOB

Washington, DC  20515

Phone: (202) 225-4061

Bruce Westerman (R-AR)

202 Cannon House Office Building

Washington, DC  20515

Phone: (202) 225-3772

Eric Swalwell (D-CA)
174 Cannon House Office Building

Washington, DC  20515

Phone: (202) 225-5065

Senate Committee on Aging

Democratic/Majority Office
G16 Dirksen Senate Office Building
Washington, DC 20510
[email protected]
Phone: 202-224-5364

Senate Committee on Aging

Republican/Minority Office
628 Hart Senate Office Building
Washington, DC 20510
[email protected]

Phone: 202-224-0185Find Your Senator

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Edward Hudgins