TREAT Act Introduced
Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act
U.S. Senator Kay Hagan (North Carolina) introduced the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act on February 15, and the National Organization for Rare Disorders (NORD) has issued a press release in support of it.
Senator Hagan’s statement describes the bill thus: “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.”
NORD supports this proposed legislation which, among other things:
•enhances and codifies the accelerated approval process
•addresses concerns of the rare disease community related to conflict of interest provisions
•provides greater clarity, consistency, and transparency in review processes
•encourages innovation and adoption of modern scientific tools in regulatory science
Senator Hagan’s statement mentions the flexibility study conducted by NORD earlier this year and the need to ensure uniformity in the application of flexibility.
For a link to NORD’s press release, including the text of Senator Hagan’s statement, visit the NNPDF’s NewsLine page.