Washington, DC (March 6, 2012) –Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood issued the following statement of support for the Faster Access to Specialized Treatments (FAST) Act, H.R. 4132, which was introduced yesterday:
“BIO thanks Representatives Cliff Stearns (R-FL) and Ed Towns (D-NY) for their leadership in introducing the FAST Act to speed access to innovative new therapies and cures to patients living with debilitating and life-threatening diseases such as Parkinson’s, Alzheimer's, diabetes and numerous rare diseases for which there is currently no treatment or cure.
“The legislation will modernize the Accelerated Approval pathway to expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases, while preserving the Food and Drug Administration's (FDA) robust standards for safety and effectiveness.
“Like the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, S. 2113, which was introduced by Senator Kay Hagan (D-NC), the FAST Act will update the Accelerated Approval process at the FDA so that it works in a transparent, predictable way for all therapies intended to treat debilitating conditions for which there is an unmet medical need. Making this change will better enable biotechnology companies to bring new, safe and effective treatments and cures to patients in need at the earliest point in time.
“We look forward to working with Representatives Stearns and Towns, Senator Hagan, and their colleagues to ensure that this critical legislation is enacted.”