The Burrill Report


The Burrill Report (February 27, 2012): A Push for Accelerated Approvals (.MP3,13.62 Mb)

Two separate bills seeking to provide accelerated approval for certain drugs have begun their trek through the legislative process in Congress. The first, known as TREAT, comes from Democratic Senator Kay Hagen of North Carolina. It would accelerate approval of drugs for unmet medical needs that significantly advance the standard of care, or are highly targeted for distinct sub-populations. The other, known as ULTRA, was introduced by Republican Representative Cliff Stearns of Florida and Democrtic Representative Ed Towns of New York, and seeks to accelerate approval for therapies for ultra rare diseases. We spoke to Emil Kakkis, founder of the EveryLife Foundation for Rare Disease and CEO of Ultragenyx Pharmaceuticals, about both bills, how they fit into the renewal of the prescription drug user fee act, and what it will take to get them passed.


February 23, 2012
http://www.burrillreport.com/article-a_push_for_accelerated_approvals.html