1. Pink Sheet

“Breakthrough Therapy”: New Pathway in FDASIA May Point The Way To Future Reforms

 
• By Michael McCaughan

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.

If you are looking for the “Innovation” piece of the FDA Safety & Innovation Act, one section of the new law jumps out: Section 902 – “Breakthrough Therapies.”

The provision creates a new section of the FD&C Act, and inserts it directly before the “Fast Track” and Accelerated Approval sections also included in FDASIA. That symbolic position indicates...

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