Experts Talk Breakthrough, Limited Population Approvals In NEJM Debate

A recent New England Journal of Medicine article, penned by Harvard professors and researchers who highlighted potential shortfalls of increasing accelerated approvals under new and proposed FDA pathways, drew strong backlash from stakeholders pushing these ideas. Officials from key stakeholder groups countered assertions that these programs lower approval standards and that drug sponsors do not adequately follow-up with postmarket studies. In March, Harvard Medical School research fellow Jonathan Darrow, and professors Jerry Avorn and Aaron Kesselheim, raised concerns that...