You raise a very interesting point. The challenge here may be that the wide availability of LDTs that are, at least for now, not addressed by FDA, makes the need for a "breakthrough" status for diagnostics less compelling. Keep in mind that the Breakthrough Drug provisions were created by Congress in last year's Food & Drug Administration Safety & Innovation Act (FDASIA). Thus, until someone pushes Congress for a similar program for diagnostics and unless FDA did so administratively, this is a glimmer in your eyes.
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Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
F: +1 619 923 2648
C +1 760 815 4762
maswit@duanemorris.com Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.
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Original Message:
Sent: 08-14-2013 15:57
From: Joy Frestedt
Subject: IVD "breakthrough" products?
If a truly "breakthrough" IVD cannot use the "breakthrough" designation with the FDA to expedite regulatory approval of IVDs, then any thoughts about how to raise this issue about the need for more expedited pathways for certain IVDs as a necessary component of the FDAs processes?
It seems this "breakthrough" pathway (or something similar) should be developed and available for IVDs with equally compelling arguments meeting the "breakthrough" definition: 1) IVD supporting a treatment for a serious/life-threatening disease/condition and 2) IVD with a substantial improvement over current technology.
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Joy Frestedt PHD, CCTI, RAC, FRAPS
President and CEO
Frestedt Incorporated
Saint Louis Park MN
United States
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Original Message:
Sent: 08-14-2013 15:40
From: Michael Swit
Subject: IVD "breakthrough" products?
The breakthrough therapy designation only applies to drugs (including biologics). Thus, IVDs are not eligible.
______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
F: +1 619 923 2648
C +1 760 815 4762
maswit@duanemorris.com
Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.
Please follow me on LinkedIN and Twitter:
http://www.linkedin.com/in/michaelswit
https://twitter.com/FDACounsel
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Original Message:
Sent: 08-14-2013 15:21
From: Joy Frestedt
Subject: IVD "breakthrough" products?
Has the US Food and Drug Administration (FDA) declared any in vitro diagnostics to be "breakthrough" products? See the associated article in Regulatory Focus. If you are aware of any FDA-designated breakthrough IVDs, please comment here or contact me at jf@frestedt.com.
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Joy Frestedt PHD, RAC, FRAPS
President and CEO
Frestedt Incorporated
Saint Louis Park MN
United States
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