“Breakthrough Therapy”: New Pathway in FDASIA May Point The Way To Future Reforms
This article was originally published in RPM Report
A new FDA designation process for “breakthrough” drugs is one of the few “innovation” features of the FDA Safety & Innovation Act. It is likely to be very attractive to biotech sponsors, though its impact on actual product approvals is uncertain at best. The real “breakthrough,” though, may be in the collaborative model that led to the legislation – and that is an important message for sponsors hoping for bigger reforms ahead.
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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.
A Friends of Cancer Research proposal to create FDA drug-device review teams in oncology, cardiology and neurodegenerative disease could find a home in the next round of FDA reform legislation. PDUFA VI. Current and former agency officials are cautiously optimistic about the idea, but combining review operations with different statutory underpinnings will be challenging.