Breakthrough Therapy Designation is an expedited approval pathway which was established as a part of the Food and Drug Association Safety and Innovation Act of 2012. This was a program created to collect user fees from the medical industry to fund reviews of new drugs, medical devices, generic drugs and copied biological medical products. The requirements to receive approval from Breakthrough Therapy Designation program
It can be applied to a serious or life-threatening disease or condition and it must be predicated on preliminary clinical evidence demonstrating substantial improvement over existing therapies on one or more clinically endpoints.
Other programs called the Fast-Track Designation, Accelerated-Approval Pathway, Priority-Review Designation are programmed with similarities on approving life-threatening and very serious diseases.
Rules for drug approval and submissions
All three programs are very different and have a part to play in the Federal Drug Administration process. All in all the FDA has approved 46 drugs in 2017 saying “innovation drives progress”.
Giapreze, for example, is a drug to increase blood pressure in adults with shock approved on December 21, 2017.
Check out this list of drugs approved : FDA 2017 Approval List
You can also check out this webcast to understand the process : Ke Liu, MD, PhD
Dr.Pazdur in interviews stated that most drugs that are trying to be passed simply do not get the go-ahead because the communication isn’t there and the clinical proof that the drug makes a difference aren’t evident. The adequate preliminary evidence is critical to receive approval in any program, and communication can help with the review decision also.