The Promising Pathway Act Hits Close to Home for the Senate
Imagine hearing your father has been diagnosed with Amyotrophic Lateral Sclerosis, or ALS—more commonly known as Lou Gehrig’s disease.
Or you get that phone call to learn that your sister has glioblastoma, an aggressive brain cancer.
Or unfathomably, your young daughter is diagnosed with a rare condition.
Then imagine being told by doctors that there is nothing you can do to treat that family member, despite promising new treatment options, simply because the new drug approval process is too long and cumbersome for new effective treatments. All you can do is watch your loved one suffer and get worse with every passing day until they move on from this life. Imagine being told that hope is just beyond reach.
That scenario is not just unbelievable—it’s unnecessary. The government should not be standing in the way of terminally ill patients receiving potentially life-saving treatments. I imagine most would agree that we need our government institutions working for us and not creating needless delays and hopelessness.
Progress in this area was made with the ‘Right to Try’ legislation of years past, but more work needs to be done to ensure that patients receive access to care, and that data from treatment is used to inform research. Congress can give families and researchers new hope through the Promising Pathway Act. This legislation is center stage right now as Congress looks to reauthorize the User Fee Program under the Food and Drug Administration (FDA), which governs the drug approval process.
The Promising Pathway Act (PPA) is simple. Currently, the drug approval process can take 10-12 years on average, though the patients who need access likely only have weeks or months. PPA rethinks the existing pathways between research and patients by expediting access to promising therapies. By increasing clinical trial flexibilities without sacrificing safety or efficacy, the legislation seeks to greatly decrease the clinical trial timeline. Instead of a decade, it would take months to develop safe new therapeutic treatments to treat, prevent, or diagnose serious or life-threatening diseases or conditions.
The past two years have taught us what many families facing terminal illness already knew: Life is precious. It can change in a moment. And we should fight for more time with loved ones, especially when such a possibility is within reach.
The Promising Pathway Act impacts the Senate family in a particularly personal way. Many members and Hill staff have family or friends who have been impacted by life-threatening illnesses with no real promise for expeditious treatments.
Michael Schwartz, who served as the late Senator Coburn’s Chief of Staff in both the House and Senate is one example. Mike lost his battle with ALS just over nine years ago at the age of 63 while working in the Senate.
I worked with Mike and saw his struggle up close. Yet, Mike was the consummate optimist and endless encourager to staff on the Hill, young and old, Democrat and Republican. Most people who worked in the House or Senate over the past three decades likely had the honor to meet, know, or be mentored by Mike. Steady and strong, day in and day out of the House and then the Senate’s tumultuous agenda and debates, Mike led with courage and a constant smile.
Mike was known by Democrats and Republicans alike as a fierce advocate for life. Shortly after his passing, Dr. Coburn praised Mike’s life, deeds, and words, saying “he is one of the kindest, gentlest people anyone has ever met. He has been a light focused on how we do things to honor other people.”
So as Congress considers reauthorization of FDA’s User Fee program, they would best honor Mike and his legacy—and all Americans fighting for more time to find treatments that work. Congress has an unhindered opportunity to truly “honor other people” by bringing hope to tens of thousands of Americans through the Promising Pathway Act.