Much hand wringing and speculation over the FDA’s recent Vanda decision. And the big question being asked is:
Is this the end of the dynamic duo of safety/efficacy and the beginning of a new Holy Trinity that includes comparative effectiveness?
Most reporting went something like this (courtesy of the Washington Post):
“Vanda Pharmaceuticals' stock tumbled 73 percent Monday after federal regulators rejected the
In fairness, the FDA didn’t actually say anything. This is how Vanda chose to represent the communications it received from the agency.
But rather than looking at this through the lens of comparative effectiveness – perhaps a better way to think about it is via comparative safety. Should inferior performance in some settings (for example if you won't know about it for weeks) be a molecule killer? The debate isn’t only (or primarily) whether it's bad to be worse – but also whether it can be easily monitored.
A tough situation for the FDA and a potential opportunity for those who would exploit this situation to call for a NICE-like system in the U.S. – such as Senators Baucus and Conrad and their “Comparative Effectiveness Research Act of 2008”
But it’s really just the latest example of why dogmatic approaches to drug regulation don’t work -- and why the Critical Path program is so essential.
Nobody said the FDA’s job was an easy one.
