ASCO submitted a letter to the U.S. House Energy and Commerce Committee responding to the committee’s second white paper on its 21st Century Cures Initiative, 21st Century Cures: An Update on the President’s Council of Advisors on Science and Technology (PCAST) 2012 Report on Propelling Innovation.
The letter to Representatives Fred Upton (R-MI) and Diana DeGette (D-CO) from ASCO President
Peter P. Yu, MD, FASCO, praises the PCAST report, but notes that the U.S. Food and Drug Administration (FDA) could take “a more coordinated approach to change.” For example, the ASCO letter suggests expanding FDA’s Sentinel Program to collect data on patients provided access to therapies approved under a proposed provisional approval process.
ASCO recommendations include supporting federal initiatives such as the National Center for Advancing Translational Sciences and the Reagan-Udall Foundation, creating a new designation for drugs shown to be safe and effective in a specific subgroup of patients, and improving FDA benefit and risk monitoring tools.
To learn more about the 21st Century Cures Initiative, please visit: energycommerce.house.gov/cures. ■
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