HER2 Support Group Forums - View Single Post - From the NEJM: The FDA's New “Breakthrough Therapy” Designation

phil · 11-19-2013, 08:24 AM

Thanks for posting this, good info, but for all these attempts to speed up the FDA, This FDA since 2009 has been more obstructive. Why ? because you can pass all the laws you want , but unless there is outside ACCOUNTABILITY , ( wake up Congress HELP Comm. !! ) , the agency can interpret and administer those laws as they see fit.
So we have an FDA that had a" fast track " law since 1997 ( probably a result of that FDAs bungling of the original herceptin approval ) , and an " Accelerated " Appr. law , yet still rejects t dm-1, has no plans to expand the label for perjeta to stage iv's. Start your stop watches on paclociclib, PD0332991, an ER + drug w/ great early stats , granted " breakthrough " status in April. There is a Petition thru "pnr" on Inspire to push This FDA on this drug. Please sign it and pass it on.
This Presidential Admin. is becoming known for the bungling of the ACA . We Stage IV BC Activists are not surprised. We have seen the results of His administrative power vacuum, and lack of accountabilty in His FDA since 2009.

11-19-2013, 08:24 AM	#2
phil Senior Member Join Date: Nov 2010 Posts: 393	Re: From the NEJM: The FDA's New “Breakthrough Therapy” Designation Thanks for posting this, good info, but for all these attempts to speed up the FDA, This FDA since 2009 has been more obstructive. Why ? because you can pass all the laws you want , but unless there is outside ACCOUNTABILITY , ( wake up Congress HELP Comm. !! ) , the agency can interpret and administer those laws as they see fit. So we have an FDA that had a" fast track " law since 1997 ( probably a result of that FDAs bungling of the original herceptin approval ) , and an " Accelerated " Appr. law , yet still rejects t dm-1, has no plans to expand the label for perjeta to stage iv's. Start your stop watches on paclociclib, PD0332991, an ER + drug w/ great early stats , granted " breakthrough " status in April. There is a Petition thru "pnr" on Inspire to push This FDA on this drug. Please sign it and pass it on. This Presidential Admin. is becoming known for the bungling of the ACA . We Stage IV BC Activists are not surprised. We have seen the results of His administrative power vacuum, and lack of accountabilty in His FDA since 2009.