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Writer's pictureAbby's Corner

Introducing Promising Pathway 2.0

Updated: Jun 13

FOR IMMEDIATE RELEASE

May 23, 2024

The new and improved bipartisan Promising Pathway Act will give

patients with terminal diseases hope for new cures and treatments.

Young boy hugs two advocates.
Ben, who suffers from rare Salla disease, attends a rare diseases Promising Pathway advocacy event.

Washington – Today, Senator Mike Braun, Senator Kirsten Gillibrand, and a bipartisan team of Senators introduced the new version of the Promising Pathway Act: a bill to give hope to thousands of Americans struggling with rare and life-threatening diseases.

 

When you’ve been diagnosed with a rare and progressive disease, access to promising treatments is the difference between life and death. 

 

It takes about 6 years on average for a drug to get through the FDA’s fastest drug approval pathway – and even longer before patients can actually take them. Those with diseases like ALS simply don’t have time to wait.

 

That’s where Promising Pathway comes in. We’ll create a conditional approval pathway for drugs intended to treat rare, progressive and congenital diseases. Think of it like a “passing lane” for drugs that have shown safety and evidence of effectiveness for patients with life-threatening diseases who don’t have time to wait.


Three advocates for the Promising Pathway Act pose for a photograph.
The Senate Aging Committee hearing on Promising Pathway Act.

Promising Pathway has seen a groundswell of support from both sides of the aisle and the patient community in the past year. Over that time, Senator Braun’s team has put together changes to the bill to help it become law and better serve patients, resulting in today’s new version.

 

Promising Pathway 2.0 was introduced by Senator Mike Braun, Senator Kirsten Gillibrand, Senator Kevin Cramer, Senator Joe Manchin, Senator Eric Schmitt, Senator Alex Padilla, Senator J.D. Vance, Senator Cory Booker, Senator Josh Hawley, Senator Peter Welch, and Senator Lisa Murkowski.

 

NewsNation’s Kristen Eskow reported on the new version of the bill and spoke to some of the patients this legislation would help:

Reporter answers questions about the Promising Pathway Act
NewsNation | Bill would allow treatment for terminally ill before FDA approval

Here’s the bill text. The bill number will be S. 4426 to follow it on Congress.gov

 

Here’s a look at some of the changes to the bill designed to help more patients and make the legislation a better candidate to become law.

 

Here’s a breakdown of what the bill does and how it will guarantee safety and efficacy.


Promising Pathway 2.0 is endorsed by the following organizations.

List of organizations endorsing the Promising Pathway Act

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