FDA’s “Breakthrough” Exceeds Expectations; Will It Break The Bank?
This article was originally published in RPM Report
Drug sponsors are eager to use FDA’s new “breakthrough” therapy development pathway, and the agency is granting designations at a much faster rate than originally expected. But the “all hands on deck” approach required by FDA officials for breakthrough is resource-intensive at a time when the budget sequestration is preventing the agency from accessing all its available user fee funding. Is the popular program at risk?
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Reflecting on the last three-plus years, agency officials say the quality of requests for breakthrough are improving, and review divisions outside of the initial base of oncology are becoming more comfortable with granting designations.
FDA is close to hitting a milestone in the short history of the Breakthrough Therapies designation: 50 indications approved under the abbreviated development and review pathway. In reflecting on the last three-plus years, agency officials say the quality of requests for Breakthrough are improving, and review divisions outside of the initial base of oncology are becoming more comfortable with granting designations.
FDA Office of New Drugs Director John Jenkins is making a case against adding “Breakthrough” user fees to PDUFA VI to better fund the program and cut back on the number of unqualified requests for designation. Rather than seek additional funding for specific programs, FDA wants fewer obligations under the user fee program; the agency is pushing back against industry proposals to add more formal meetings.