The Vitals

Senate Passes Bill Directing FDA To Consider Patient Perspective In Approvals

August 03, 2017
The Senate passed a bill by unanimous consent Thursday (Aug. 3) from Sens. Roger Wicker (R-MS) and Amy Klobuchar (D-MN) that seeks to increase the patient's role in FDA's risk-benefit determination for drug approvals. The Wicker-Klobuchar bill would add language to the drug law's section on “consultation with external experts on rare diseases, targeted therapies, and generic targeting of treatments,” stating: “(C) as part of the risk-benefit assessment framework in the new drug approval process described in section 505(d), considering...

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