A greater investment in comparative effectiveness research appears inevitable, whether or not Congress creates a federally funded agency to conduct head-to-head trials. The Vytorin debacle is only the most recent reason why industry is wary. But there are steps pharma can take to prepare for the next big thing in health care policy. Despite Vytorin, Merck is one of the companies leading the way.

An abbreviated pathway for follow-on biologics just missed getting tacked onto the FDA user fee/drug reform legislation. It will be years before proponents get another shot at creating an abbreviated approval pathway for the biotech copycats. So who won and who lost?

A draft EU guideline explains how disease registries can be used to supplement evidence in the pre-authorization phase and provide infrastructure for post-authorization evidence generation.