Heidi Alexander: “while we are waiting for Senator Murphy, let me salute Senator Kirk for his leadership from the very beginning. He has…”

“while we are waiting for Senator Murphy, let me salute Senator Kirk for his leadership from the very beginning. He has pointed out to the committee and the Senate that, as the Mayo Clinic has said, regenerative medicine is a game changer for stroke victims, for heart disease, and for people with retinal disease. Thanks to Senator Kirk, Senator Collins, Senator Manchin, and Senator McConnell, we have legislation that takes an important and responsible step forward to recognize the promise of regenerative medicine. This bill includes $30 million to the National Institutes of Health for clinical trials to support regenerative medicine. Then there are two other provisions in the bill. One of them allows the Food and Drug Administration to make regenerative therapeutic products eligible for the FDA's existing accelerated drug approval pathway. We have had great success over the last 4 or 5 years with an accelerated pathway for drugs, similar to what Senators Burr and Bennet and others got enacted into law. We are doing the same thing with combination drugs and devices in this legislation. Now Senator Kirk has added regenerative medicine to the accelerated pathway, and I salute him for that leadership. The PRESIDING OFFICER. The Senator from Illinois.”