The Promising Pathways Act

With COVID-19 taking up so much of the news cycle, it can be easy to forget about those living with debilitating illnesses like ALS. Even as scientists continue researching a coronavirus vaccine and working to make the impact as small as possible on America, I believe we need to continue providing cutting-edge treatment and medications to those with chronic illnesses. Unfortunately, the approval process for many of these prescription drugs is time-intensive and burdensome, causing those who need the medicine most to experience delays in care.

This is why I joined several of my colleagues in introducing the bipartisan, bicameral Promising Pathways Act. It's important because the Food and Drug Administration (FDA) refers to the clinical trial process for prescription drugs in phases, i.e. Phase I, II and III. Early clinical trials (Phases I and II) establish and confirm safety while providing a considerable amount of data, often enough to statistically predict successful confirmatory trials. Confirmatory trials (Phase III) further test effectiveness and are the last step to a drug entering the market for patients' use. However, Phase III trials are extremely time-consuming and expensive, in some cases costing billions of dollars. If the FDA determines a drug doesn't meet its standards, small pharmaceuticals attempting to bring innovative drugs to market can go bankrupt during Phase III trials.

The Promising Pathways Act would allow pharmaceutical companies to petition the FDA for provisional approval if the drug has cleared early stage clinical trials, already having proven safety. The company could then sell their drug at a market acceptable rate, give patients access to innovative treatments and compete with large, monopolistic pharmaceuticals to lower consumer cost. Sen. Mike Braun has introduced a companion bill in the Senate, and I hope that we can quickly get this legislation signed into law so that critically ill Americans can access the medication they need.