Last November, the Center for Medicine in the Public held a confab entitled, “PDUFA without the Politics.” Many of the predictions from the event’s expert panelists seem to be coming true.
AS PREDICTED, the current conversation surrounding the reauthorization of the Prescription Drug User Fee Act (PDUFA) must focus on (among other things) the First Principle of Predictability as well as ensuring that the FDA can fulfill its role as an important ally in advancing healthcare in America.
The draft bill extends 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."
AS PREDICTED, the House Republican discussion draft incorporates the Generating Antibiotic Incentives Now (GAIN) Act, which would extend market exclusivity by five years for drugs that treat antibiotic-resistant pathogens
AS PREDICTED, by Representative Michael Burgess at the CMPI conference, 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.
The discussion draft also includes language intended to expand accelerated approval. The accelerated approval provisions are similar to those in the FAST and TREAT acts.
Is there still room for a few more Christmas Tree ornaments? Perhaps permanent renewal of the Best Pharmaceuticals for Children’s Act and PREA?