Compassionate Use: An Especially Tough Case

Update: Chimerix says this evening that they will make their drug available to the boy in question as part of a new 20-patient open-label trial, after discussions with the FDA. This might have been the best way out of this, if it gives the company a better regulatory path forward at the same time. My guess, though, is that the company's position was becoming impossible to maintain no matter what.

Many of you will have seen the stories of a dying 7-year-old whose parents are seeking compassionate use access to a drug being developed by Chimerix. It's hard reading for a parent, or for anyone.

But I can do no better than echo John Carroll's editorial here What it comes down to, as far as I can see, is that a company this size will go bankrupt if it tries to deal with all these requests. So under the current system, we have a choice: let small companies try to discover drugs like this, without granting access, or wipe them out by making them grant it. Even for large companies, it's rough, as I wrote about here. I don't have a good solution.

Source: In the Pipeline - March 11, 2014 Category: Chemists Tags: Drug Development Source Type: blogs