McSally Introduces Bill to Accelerate Life-Saving Treatments for Patients with Chronic Illnesses

Press Release

U.S. Senators Martha McSally (R-AZ), Mike Braun (R-IN), and Lisa Murkowski (R-AK) this week introduced the Promising Pathway Act (S. 3872) to give those struggling with serious and life-threatening illnesses a fighting chance at receiving meaningful treatments.

The Promising Pathway Act requires the U.S. Food and Drug Administration (FDA) to establish a rolling, real-time, priority review pathway to evaluate provisional approval applications for drugs intended to treat, prevent, or diagnose serious or life-threatening diseases or conditions, including those that pose a threat of epidemic or pandemic.

Under this pathway, provisional approval would be granted by the FDA to drugs demonstrating substantial evidence of safety and relevant early evidence of positive therapeutic outcome(s).

"Americans suffering from terminal conditions do not have time to wait months on end for the approval of potentially life-saving treatments," said Senator McSally. "Our legislation allows access to more 21st century therapies by creating another pathway at the FDA that will safely accelerate its approval process for drugs meant to treat chronic or life-threatening diseases for patients battling critical conditions like ALS or advanced stages of cancer."

"There are things we can do right now to help those fighting for their lives every day against terminal illnesses that will also better prepare us for pandemics like the coronavirus," said Senator Mike Braun. "The current system doesn't work for those with serious and life-threatening illness. A provisional drug approval pathway--designed to promote efficient access to effective treatments for patients with progressive diseases--will bring us closer to fixing the system for those who don't have time to wait."

"In the current environment, Americans are all too familiar with the devastating impact of deadly, fast-moving diseases with no known cure. Unfortunately, many have been living with this reality for far too long, as they and their families deal with tragic diseases such as ALS. Accelerating and clarifying FDA approval pathways for promising new treatments is more important now than ever," said Senator Murkowski. "We know that ALS is a tragic disease, but with advances in research, treatment, and advances in clinical trials, my hope is that we are closer to a cure for ALS. Our legislative effort recognizes that patients suffering from life-threatening, fast-moving diseases may benefit from access to promising treatments earlier. While we work towards the day we have promising cures, anything we can do to accelerate pathways to treatment, is a step in the right direction."

"The FDA must be an innovation-enabler. A provisional approval pathway is consistent with the FDA's goal of advancing 21st century patient-focused medicines regulation. The Promising Pathway Act is a public health triple play--Good for patients, good for innovation, good for the broader public health." -- Peter J. Pitts, Former FDA Associate Commissioner, President and Co-Founder of the Center for Medicine in the Public Interest

"Every year thousands of Americans are diagnosed with ALS and told to get their affairs in order. This legislation gets us ever closer to a place where we can say, "you have ALS, here is an effective therapy that will allow you to see your children and grandchildren grow up.' We fight every day to make that day real," says Danielle Carnival, CEO of I AM ALS.

"We are grateful for Senator Braun's commitment to and leadership in the fight to end ALS and to make real treatments for so many now. This critical legislation provides the opportunity to dramatically speed up the race for treatments for ALS patients and so many others by providing a real, long-overdue pathway access to promising therapies," says Brian Wallach, ALS patient and co-founder of I AM ALS.

"The ALS Association strongly supports the Promising Pathway Act to create a faster pathway for new therapies," said Calaneet Balas, president and CEO of The ALS Association. "This bill advances efforts to bring effective treatments to everyone with ALS as soon as possible. We look forward to working together to ensure Congress passes this bill quickly."

"The Promising Pathway Act may serve a critical need we have for accelerated drug approval for children facing terminal brain cancers. For years we've watched promising treatments languish at bureaucratic hurdles set to consider side effects when the alternative for these children was almost certain death. We are hopeful that now these options can be offered as they develop and lives will be saved." --Keith Desserich, Co-Founder of The Cure Starts Now International Cancer Foundation, Founder of the DIPG/DMG Collaborative, President of the Pediatric Brain Tumor Consortium Foundation.

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