ARTICLE | Politics & Policy

Patient advocates discuss PDUFA VI aims

July 16, 2015 1:19 AM UTC

At a public meeting Wednesday on PDUFA reauthorization, patient advocacy organizations called for expanding and adding rigor to FDA's efforts to integrate patient perspectives into regulatory decision-making. Negotiations for PDUFA VI will start this September among FDA and industry, patient and consumer groups; PDUFA V will sunset on Sept. 30, 2017.

Jeff Allen, executive director of Friends of Cancer Research, said at the meeting that PDUFA VI goals could include "developing methodological considerations for areas such as the collection of patient experience data outside of the development process, quantifying benefit-risk balances for different diseases, or for incorporating patient-reported outcome tools for different contexts of use within drug development." ...