BISMARCK – Thousands of Americans struggling with rare and life-threatening diseases are stuck waiting for new cures to make their way through the U.S. Food and Drug Administration’s (FDA) arduous approval process. This unfair delay often leaves patients with terminal or untreatable diagnosis with no options. But by creating conditional pathways to expedite treatment options, barriers to timely care can be safely reduced for those who cannot afford to wait.
U.S. Senator Kevin Cramer (R-ND) joined U.S. Senators Mike Braun (R-IN) and Kirsten Gillibrand (D-NY) in introducing the Promising Pathway Act 2.0 to give hope to these patients by giving them treatment options without unnecessary delay. Specifically, the legislation would allow for a two-year, conditional approval of an eligible drug intended to treat rare and terminal illnesses, prior to obtaining full approval by the FDA.
“The current Food and Drug Administration process forces patients to fight and advocate for themselves in a system not designed to work for them,” said Cramer. “The Promising Pathway Act 2.0 removes barriers, giving providers flexibility and patients and their families hope at the time it’s needed most.”
Additional cosponsors include U.S. Senators Joe Manchin (D-WV), Eric Schmitt (R-MO), Alex Padilla (D-CA), J.D. Vance (R-OH), Cory Booker (D-NJ), Josh Hawley (R-MO), Peter Welch (D-VT), and Lisa Murkowski (R-AK). The legislation is endorsed by more than 100 organizations.
Click here for bill text.