Reagan-Udall To FDA: Launch Task Force With CMS, NIH On Postmarket Trials

The Reagan-Udall Foundation is calling for FDA to spearhead an interagency task force that includes CMS and the National Institutes of Health to devise a way to collect post-market data that meets product reviewers, payers and researchers' needs. The call comes amidst a heated debate over whether CMS is second-guessing FDA’s approvals by limiting coverage and imposing its own post-market requirements, and as the broader health care system grapples with how to collect and use real-world data. The non-profit group...