Unbiased Analysis of Today's Healthcare Issues
FDA has two competing priorities. On the one hand, they want to collect as much data as possible to insure drugs are safe and effective; on the other hand, patients want access to innovative medicines as quickly as possible. To try to balance these priorities, FDA often will approve treatments based on evidence from surrogate…
The Economist has an article on the evolution of FDA regulation of pharmaceutical treatments. Brining a drug to market costs billions of dollars. FDA commissioner Scott Gottlieb aims to cut this cost by expediting the drug approval process in three key ways. First, he wants the agency to rethink how much information the FDA demands…
An interesting paper from some of my colleagues at Precision Health Economics: Approval of new drugs is increasingly reliant on “surrogate endpoints,” which correlate with but imperfectly predict clinical benefits. Proponents argue surrogate endpoints allow for faster approval, but critics charge they provide inadequate evidence. We develop an economic framework that addresses the value of…