Comparative effectiveness and the FDA
Speaker comments:
Is more knowledge better? Should I have access to everything? Should drugs not be provided until they are proven to be better? And how strong does the data need to be to prove this?
These presumptions are all in the aim of increasing effectiveness at a decreased cost. Will the need for evidence stifle innovation? Healthcare cannot be divorced from politics.
Audience comments:
Pharma should have the responsibility to design their trials with the policy and access in mind, because formularies are not decided by trained academics.
It is important to tease out externalities, such as tort law and financial limitations, to allow for the standardization of care
Key quotes:
“CMS has to lead the way. The private sector won’t.”
We “must embrace an upper limit on healthcare to get traction to move. This will reveal the opportunity costs”
