PDUFA Draft Makes Changes to FDA Mission, Regulatory Pathways
Posted 14 March 2012 | By
A new draft of the Prescription Drug User Fee Act (PDUFA) legislation that provides nearly half of the US Food and Drug Administration's (FDA) funding makes several significant changes to the agency, reports BioCentury.
A discussion draft circulating among House Republicans "includes an updated FDA mission, language intended to expand accelerated approval and incentives for antibiotic drug development."
The accelerated approval language is reportedly similar to legislation separately introduced by Senator Kay Hagan (Transforming the Regulatory Environment to Accelerate Access to Treatments Act) and Reps. Cliff Stearns and Edolphus Towns (Faster Access to Specialized Treatments Act).
The bill would also make substantial changes to FDA's mission, which is currently focused almost exclusively on promoting public health.
The new mission would expand this language to include "advancing medical innovation; promoting economic growth and job creation; promoting predictability and allowing flexibility; identifying and using the most innovative and least burdensome tools for achieving regulatory ends; and incorporating a "patient-focused benefit-risk framework that accounts for varying degrees of risk tolerance, including for people living with a life-impacting chronic disease or disability," reports BioCentury.
Read more:BioCentury - House PDUFA draft modifies FDA mission