To expedite positive patient outcomes, U.S. Sen. Martha McSally (R-AZ) on June 3 introduced a GOP-led bill that would establish a time-limited provisional approval pathway for certain drugs and biological products.
“Americans suffering from terminal conditions do not have time to wait months on end for the approval of potentially life-saving treatments,” Sen. McSally said.
She is an original cosponsor of the Promising Pathway Act, S. 3872, with bill sponsor U.S. Sen. Mike Braun (R-IN), which would require 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, according to a bill summary provided by Sen. McSally’s office.
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 outcomes, according to the summary.
“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,” said Sen. McSally.
A three-page bill summary provided by the lawmakers notes that FDA drug approval pathways “must be continually rethought and redesigned to promote efficient access to effective treatments for patients with progressive diseases that, if left untreated, may significantly affect their daily lives or lead to premature death.”
Among numerous provisions, S. 3872 stipulates that drugs and biological products granted provisional approval under the pathway established by the bill would be limited to a two-year approval period, renewable every two years, for up to six years, according to the text of the bill.
Additionally, the bill states that full approval may be awarded at any time, for any drug or biological product provisionally approved under the pathway that establishes a 15 percent improvement in an important endpoint compared to standard therapies.
The legislation has garnered the support of the Center for Medicine in the Public Interest, I AM ALS, and The ALS Association, among others.