Prescription Drug User Fee Act and PDUFA Briefing March 7

Source:Hoosiers Work for Health

This week, PhRMA President & CEO John Castellani weighed in on this year’s must-pass legislation on the reauthorization of the Prescription Drug User Fee Act (PDUFA) by issuing a statement that calls for balance in addressing the biopharmaceutical development process, not sweeping general approaches. Careful consideration of the benefit-risk balance is essential, he said, especially when evaluating patients with unmet medical needs.

“Where does investment fit in to pursuing complex scientific R&D, working to enhance regulatory flexibility and focusing on safety? I understand that investment in biopharmaceutical R&D can be a daunting proposition. It’s lengthy, it’s costly, and it’s risky. And in an industry in which venture capital investment has historically played an important role, we certainly do not want to dissuade investment that can help lead to both medical advances and job growth.” Read Castellani’s remarks in full HERE.

Hoosiers Work for Health is holding an Educational Briefing on March 7 to discuss the important 2012 federal issues that impact the life sciences industry, including PDUFA. The event will be held March 7 from 9-10 a.m. at Bose Public Affairs Group in the Chase Tower, 111 Monument Circle, Suite 2700. For more information on this event or to register, email Laura McCaffrey at


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