Pete Domenici: “I rise in support of S. 830, the FDA Modernization Act. This bill provides comprehensive--and long overdue reform to the…”

“I rise in support of S. 830, the FDA Modernization Act. This bill provides comprehensive--and long overdue reform to the FDA. The primary focus of S. 830 is to streamline and strengthen the FDA's review and approval of lifesaving drugs and medical devices. One important mechanism for doing this is the Prescription Drug User Fee Act [PDUFA]. PDUFA authorizes the FDA to use fees collected from prescription drug manufacturers to expedite the FDA's review of drugs. The fees collected go to hiring new employees to increase the FDA's resources for reviewing new drugs. With all of the advances in science and medicine, we must ensure the swift review of new drugs for life-threatening diseases. When there are backlogs and delays in drug approval, American lives can be lost. For example: The 7-year delay in the FDA's eventual approval of beta blocker heart medicines cost the lives of 119,000 Americans; and The FDA's 3 rac{1}{2}-year delay in approving the new drug Interleukin-2 (IL-2) cost 25,000 Americans to die of kidney cancer, even though the drug already had been approved for use in nine other countries. This bill is good because it will give Americans access to lifesaving medication, without needless delay.”