Senators Introduce FDA ‘Provisional Approval’ Bill
Senators Mike Braun (R-IN), Lisa Murkowski (R-AK), and Martha McSally (R-AZ) have introduced the Promising Pathway Act (S. 3872) that would 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. “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 outcome(s),” the lawmakers say in a release.
The senators say that FDA currently has the legal authorities to establish such a pathway, and they point to the 1990s and the agency’s parallel track system as supporting such a change. Late last year, a first draft of the legislation was released and interested parties were encouraged to submit comments to support any revisions. Based on the feedback, the senators say that for a drug to be eligible, “it must be intended for the treatment, prevention, or medical diagnosis or serious or life-threatening diseases or conditions in which there is a reasonable likelihood that premature death or disability will occur without early medical intervention, a disease or condition that poses a threat of epidemic or pandemic, or a disease or condition that is associated with morbidity that substantially impacts day to day functioning. Additionally, to receive provisional approval status, a drug must demonstrate substantial evidence of safety and relevant early evidence of positive therapeutic outcome(s).”
Read a section by section summary of the Promising Pathway Act