Orrin Hatch: “I appreciate that question. We must continue to urge the FDA to fully implement its relatively new authority. Every one…”

“I appreciate that question. We must continue to urge the FDA to fully implement its relatively new authority. Every one of us in this body represents constituents who are battling rare diseases, and I urge the FDA to consider this flexibility as applied in reviewing all candidates' therapies. I will continue to work closely with my Senate colleagues to ensure that the FDA uses the tools, authorities, and resources required to provide patients and physicians with new treatment options. I have also contacted the FDA frequently during the past year to encourage the agency to listen to the voices of patients during the agency's evaluation process. When the Senate considers the nominee for FDA Commissioner, I will continue to stress the importance of incorporating a balanced and flexible approach when weighing risks, benefits, and outcomes, especially when dealing with small patient populations with such rapidly progressing prognoses. Patients with limited or no treatment options are depending on FDA to utilize the flexibility outlined in FDASIA. This law, which provides full and fair review of new drug therapies in a timely manner, gives hope to patients suffering from life threatening diseases and, of course, their families as well. I ask Senator Klobuchar, how can we move forward into the next user fee agreement?”