Dendreon isn't the only developer that has a beef with the FDA. Pharmalot writes up the case of Pharmacyclics CEO Richard Miller, who has found a soap box on some high profile news outlets to take the agency to task for rejecting the company's cancer drug. Miller's been on CNBC and on the op-ed pages of the Wall Street Journal to make the case that experimental drugs for terminal diseases should be treated differently than traditional meds.
"The FDA seems to be using a one-size-fits-all approach and seems to be regulating drugs that are intended for serious disease, life-threatening diseases, the same way they might regulate a drug that's used to treat a headache," says Miller.
- read the report [1] from Pharmalot
Related Articles:
Industry exec says FDA approval process too strict. Report [2]
FDA quick to reject drugs as it gets more cautious. Report [3]
Links:
[1] http://www.pharmalot.com/2008/01/pharmacyclics-the-fda-and-the-deadly-dilemma/
[2] http://www.fiercebiotech.com/story/industry-exec-says-fda-approval-process-too-strict/2007-08-01
[3] http://www.fiercepharma.com/story/fda-quick-reject-drugs-it-gets-more-cautious/2007-08-20