Kay Hagan: “today I am proud to introduce the Transforming the Regulatory Environment to Accelerate Access to Treatments, TREAT…”

“today I am proud to introduce the Transforming the Regulatory Environment to Accelerate Access to Treatments, TREAT, Act. This bill empowers the Food and Drug Administration to ensure consistent processes and a clear and effective pathway that will encourage the development of innovative treatments to benefit patients, particularly subpopulations and those with rare diseases, and improve the public health. Without question, the FDA plays a critical role in helping to ensure that new medicines are safe and effective. At the same time, by promoting investment in and development of innovative treatments for unmet medical needs, the FDA can positively influence our national strategy to identify and treat serious and life-threatening diseases and improve the quality of life for millions of Americans. In order for FDA to accomplish this goal, however, Congress needs to give the agency the tools necessary to transcend existing barriers, reform its processes, and provide greater clarity, consistency, and transparency to industry. The bill accomplishes this in three ways. First, it provides the FDA with the authorities and tools that are reflective of the agency's responsibilities and that are necessary to ensure maximum operational excellence by updating FDA's mission statement and creating a management review board.…”