Rare Diseases Deserve Access to Accelerated Approval – Call Congress TODAY!

  • Posted by Melinda L on July 27, 2013 at 4:30pm

It only takes a few minutes to make a call and make a difference!

fdaRare Diseases Deserve Access to Accelerated Approval – Call Congress TODAY!


The FDA recently issued a draft guidance on the Expedited Approval Programs which they say fulfills the FDASIA mandate on Accelerated Approval for Rare Diseases, however the guidance does not address specific issues related to rare disease drug development as required by FDASIAThis is unacceptable!  

 URGENT ACTION is needed from the patient community to ask Members of Congress to sign onto the Congressional Letter urging FDA to improve access to Accelerated Approval for Rare Diseases!  Please take five minutes to call and/ or email your Member of Congress today!

Not sure who your representative is, just click here:

http://www.house.gov/representatives/find/   &  add your zip code

Call and ask to speak to the staffer who works on Healthcare issues.

You can use the following script. Just add your information:

Hello my name is [ —     ]  and I live in [ —-  ]   As a constituent , I am [calling /writing] regarding an urgent request for my Representative, [Rep. ??], to sign onto the Congressional letter urging the FDA to fully implement the rare disease requirements in the Food & Drug Administration Safety and Innovation Act known as FDASIA. As someone who struggles [or has a child] from the effects of CMT, a degenerative neuromuscular disorder, this issue is very important to me.

The letter simply asks the FDA to ensure that rare diseases have access to the Accelerated Approval pathway, which is required by FDASIA. To sign onto the letter please contact Tom Power in Rep. Bilirakis’ office 202-225-5755. Thank you for your time.

To find out more information about the FDA’s draft guidance, FDASIA and Accelerated Approval go to:  www.everylifefoundation.org/action-alert-accelerated-approval

This entry was posted in Charcot-Marie-Tooth disease and tagged , , , , , , , , , , , , , . Bookmark the permalink.

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