Promising Pathways Act would speed up drug approvals for terminal patients

ROCHESTER, N.Y. – If you or a loved one has been diagnosed with a life-threatening illness, minutes and days are precious and if there is a treatment that can allow you to have more of them, it’s a gift. That’s why there’s a push to speed up the FDA’s approval of certain drugs that can help those with terminal illnesses. 

The legislation is called the Promising Pathways Act, and it’s sponsored by Senator Kirsten Gillibrand. It was introduced in 2021 and has been gaining steam in Washington since. If passed, it would accelerate the FDA’s approval process for drugs intended to treat diseases like ALS, Parkinson’s, and Alzheimer’s. 

Right now, it can take a decade before a new drug becomes widely available. This legislation could reduce that wait time to several months for those in life or death situations. If approved, any patient eligible would have to agree to be included on an observational registry and would have to consent to the collection of data related their use of the drug until it receives full approval. Patients would also have to agree not to sue the drug manufacturer if it turns out the treatment is unsafe or ineffective. 

Those are terms Jeff Ballard would readily agree to. He is currently living with ALS.

“Those with ALS face many challenges, are given little hope, and have little time,” says Ballard. “Our risk-profile and urgency in regards to accessing new treatments and promising treatments is different than that of the general population. A 10-12 year approval timeline for a drug, is literally two to three lifetimes for an ALS patient.” 

Ballard joined Senator Gillibrand at a press conference on Thursday where she pledged to push the legislation in Washington.

“We don’t have to sacrifice the safety and efficacy of the FDA approval process for rare disease patients to access promising therapeutics. We can give patients informed access to new and promising treatments even while research is ongoing,” Gillibrand says.