FDA approves $294,000/yr cystic fibrosis drug

I know it’s not cardiology related, but I was in a conference today on drug development with Dr. Robert Califf (www.drrobertcaliff.com), and he referenced the recent FDA approval of Kalydeco.  A twice daily oral drug deemed effective in treating patients with cystic fibrosis, Kalydeco may cost as much as $294,000 per year!


Although the jurisdiction of CMS and FDA have traditionally not overlapped, one can imagine how regulatory bodies and payers must work together in a cost-constrained environment.  We need new approaches to drug development and clinical trials that allow effective and safe drugs to rapidly come to market without being cost-prohibitive.


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