ROCHESTER, N.Y. (WROC) — With no cure or effective treatment for terminal illnesses like ALS, Senator Kirsten Gillibrand is pushing new legislation called the Promising Pathway Act.
It includes a call on the FDA to expedite the approval of drugs intended for the disease, among others.
Jeff Ballard was diagnosed with ALS in 2017. The motor neuron disease causes the brain to stop sending messages to muscles, causing them to weaken and waste away.
Ballard says while the progression of the disease hasn’t been aggressive, he says it is taking a toll.
“Our urgency in accessing new treatments and promising treatments is different than that of the general population,” said Ballard.
With the proposal of the Promising Pathway Act, Sen. Kirsten Gillibrand, along with Sen. Mike Braun, hopes to accelerate the FDA’s approval process of drugs that can bring promising treatments to those in need.
“We can give patients informed access to new and promising treatments even while research is ongoing,” said Gillibrand, “Such provisional approval would only be granted if the FDA determines there is substantial evidence the drug is safe and effective in pre-clinical trials.”
Gillibrand says the legislation would also include other life-threatening diseases, like Parkinson’s, Alzheimer’s, and more.
Currently, the standard approval process by the FDA takes years to get drugs on the market.
“A 10 to 12-year approval timeline for a drug is literally two to three lifetimes for an ALS patient,” said Ballard.
The legislation is slated to go before the House for approval.
“The Promising Pathway Act is a ray of hope for those diagnosed with rare diseases. It’s bipartisan and common sense,” said Gillibrand.