Haystack Project Pushes for Smart Reform, Not Lower Standards in Rare Disease Drug Approvals

 
 

In an Inside Health Policy article, the Haystack Project responds to FDA Commissioner Marty Makary’s proposal for faster rare disease drug approvals without randomized trials. While supporting quicker access, Haystack warns that lowering standards could hurt patients by leading to insurance denials. They advocate for alternative evidence pathways that maintain the FDA’s rigorous “substantial evidence” standard and call for Congressional action. Read here.


 

 Haystack Project working with Janet Woodcock on a New Rare Disease FDA Approval Pathway

 

Don’t have time to watch? Find the transcript here.

IN THE PRESS:

Read Pink Sheet Article here.

Read Inside Health Policy Articles here and here.

Read BioCentury Article here.

Wednesday, October 23, 2024: Capitol Hill Event - When Exceptions Need Their Own Rule: A New Rare Disease Approval Pathway

moderated by Janet Woodcock Haystack Project’s mission-focused advisor

Panelists:

Kara Berasi Haystack Project, CEO

Jeanne Ireland Former Senior Advisor to the Commissioner, FDA

David Fox Former Associate Chief Counsel, FDA

Tam Roshan Lal Chief Medical Officer, Uncommon Cure

 

Mark your Calendar for the follow-on Capitol Hill Event