House PDUFA draft modifies FDA mission

A discussion draft of PDUFA reauthorization legislation drafted by House Republicans includes an updated FDA mission, language intended to expand accelerated approval, and incentives for antibiotic drug development. The accelerated approval provisions are similar to those in the FAST and TREAT acts (see BioCentury, March 12).

The bill would extend FDA's mission 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." The bill also completely removes limits on issuance of conflict-of-interest waivers for FDA advisory committee participation that were enacted as part of the FDA Amendments Act. ...