The Right to Try – Why Accelerated Approval is Needed for Eteplirsen
December 3, 2015
Darcy Olsen, author of The Right To Try was a guest speaker on a recent NPR Diane Rehm’s show, talking about Jenn McNary’s story. Guest speakers included FDA representative Dr. Peter Laurie who speaks on the role of Expanded Access programs. The show highlights how difficult access (compassionate Use, clinical trials, expanded access) is to potentially life saving drugs in our country today. It also walks through how some decisions are made providing that access, what role pharmaceutical companies can have, how patients and families also can play a role and what role the FDA is trying fulfill. This is a hot topic in healthcare today. Given it takes about 15 years to get a drug to market, this debate seems to beg the question, would faster approvals, via paths like accelerated approval, solve some of these issues?