Autoimmunity Research Foundation, Progressive Multiple Sclerosis, MS, FDA

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Progressive MS patients need your help to motivate FDA change.

In April, the FDA incentivized development of a new drug for Pediatric Multiple Sclerosis. It granted 'orphan' designation to defray costs of testing and approving a new drug for kids. But FDA still refuses to help those dying of the progressive phases of MS, refuses to designate 'orphans' for Progressive Multiple Sclerosis.
Modern Genomic Science has already identified potential solutions, but the FDA has no expertise in Genomic Science, and is moving at a snail's pace as it brings the process of 'orphan' designation and approval into the 21st century.
• Please help CureTheProcess.org by contacting your Congressman and Senators now.
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• Click here to write your own email to Congress, specifically about MS.

Prof. Trevor Marshall, President of the Autoimmunity Research Foundation, reports "It is clear that FDA needs to define procedures to acquire the expertise to properly evaluate advanced genomic and molecular science" and adopt "transparency and accountability with sponsors and the public." He offers FDA/OOPD the opportunity to work with the ARF to set clinical endpoints which are more relevant to actual patients and their families, instead of endlessly studying mouse 'models'.

Mary K. Pendergast, J.D., LL.M., FDA Deputy Commissioner from 1990-1998, and architect of the accelerated approval program, explains that Congress has given FDA plenty of freedom, but the FDA needs bold leadership at this critical time. She states "The FDA has all the authority it needs to be wildly flexible when it comes to Orphan Drugs and ... the agency, as a whole, is choosing not to use the flexibility..." and "The law hasn't changed, except to become more flexible. But like barnacles on a boat, the [FDA] requirements have aggregated... over time. But ...you don't have to impose every barnacle..."

Dr Emil Kakkis,, President of the Kakkis Every Life Foundation and CureTheProcess.org describes his experience with FDA drug designation processes, and explains why there is a need to 'CureTheProcess'

Professor Marshall briefly explains the science and the Foundation's discoveries at the Asian Congress on Autoimmunity. There is more detail from the many other scientific conferences he attends around the world. See other videos on the Foundation's YouTube channel:
http://www.youtube.com/user/DrTrevorMarshall
and on Vimeo:
http://www.vimeo.com/user450718/videos

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