Senate Bill Provides More Certainty To Pediatric Priority Review Program Than 'Cures'

Sen. Robert Casey (D-PA) introduced his own version of legislation to make the FDA pediatric priority review program permanent, as well as modify the definition of “rare pediatric disease” to include any form of sickle cell disease and any pediatric cancers. An industry attorney lauded Casey's bill an improvement over the House version, which excludes foreign-approved drugs for tropical disease indications, and the pediatric review language in the House-passed 21st Century Cures Act by providing more certainty to the program...