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Thursday, November 7, 2024

Senators introduce bill to expedite drug approval for rare diseases

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Senator Kevin Cramer, US Senator for North Dakota | Senator Kevin Cramer Official website

Senator Kevin Cramer, US Senator for North Dakota | Senator Kevin Cramer Official website

Thousands of Americans with rare and life-threatening diseases face delays as they wait for new treatments to pass through the U.S. Food and Drug Administration’s (FDA) approval process. This often leaves patients with terminal or untreatable diagnoses without viable options. However, by creating conditional pathways to expedite treatment options, barriers to timely care can be reduced for those who cannot afford to wait.

U.S. Senator Kevin Cramer (R-ND) has joined U.S. Senators Mike Braun (R-IN) and Kirsten Gillibrand (D-NY) in introducing the Promising Pathway Act 2.0. The legislation aims to provide hope to these patients by offering treatment options without unnecessary delay. Specifically, it proposes a two-year conditional approval of eligible drugs intended to treat rare and terminal illnesses before obtaining full FDA approval.

“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.

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