Continuing the Discussion of “Conditional Approval” and the Accelerating Access/Ensuring Safety and Efficacy Dilemma

Last week I commented on an excellent New England Journal of Medicine article by Darrow, Avorn and Kesselheim -New FDA Breakthrough-Drug Category- Implications for Patients, 370 New Eng. J. of Med. 1252-1258 (March 27, 2014)- on the problems of accelerated approval. Then today my attention was drawn to another excellent article on the early access dilemma for critically ill patients: Karl Thiel, Did Chimerix, Inc. (CMRX) Set A Bad Example For Biopharma?, available at http://www.biospace.com/News/Did-Chimerix-Set-A-Bad-Example-For-Biopharma/328076?type=email&source=BE_032614 (visited April 4th 2014). The topic is clearly an extremely important one, and in need of much more serious discussion. Continue reading