The USA’s Genetic Alliance (GA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have announced an initiative to explore the use of a technology-enabled, crowd-sourcing approach to patient engagement with ongoing patient-focused drug development efforts under the Prescription Drug User Fee Act (PDUFA).
As part of the reauthorization of PDUFA, the US Food and Drug Administration committed to gain the patient perspective on 20 disease areas in public meetings to be held between 2012 and 2017.
Sascha Haverfield, vice president of scientific and regulatory affairs at PhRMA, said: “PhRMA is fully supportive of FDA’s efforts to advance patient-focused drug development and seeks to contribute additional patient-driven data that reflect a range of patient perspectives on issues such as severity of conditions and unmet medical needs over time.”
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