FDA Practicing Stealth Comparative Effectiveness? What's So Stealth About it?
Posted on Fri, Dec 04, 2009 @ 11:14 AM
The In Vivo Blog has a very interesting discussion about a recent Pink Sheet/CMS 
Summit Panel discussion that suggested that the FDA may be practicing "stealth" comparative effectiveness through an increasingly greater focus on superiority data (rather than, I presume, non-inferiority data). Read it here at In Vivo.
The blog raises a number of interesting points, not the least of which is the question that is on many people's minds, including physicians, patients and industry: "is the FDA becoming too conservative?"
I believe that this question needs to be considered as part of the overall discussion, debate and analysis of issues such as the decline in new molecular entities, fewer first action FDA approvals, and fewer treatment options available for patients who need them.
A decline in R&D productivity has contributed to these issues to be sure, but I don't believe that industry is to blame for all of it. Open and honest discussion and debate is in the best interests of everybody, especially patients.