In Law360, FDA Regulatory Attorneys Examine How COVID-19 May Spur Passage of Lab Test Reform Legislation

A Law360 article authored by FDA regulatory partner Greg Levine, counsel Beth Weinman and associate Michael Purcell (all of Washington, D.C.), examine how the COVID-19 pandemic may spur passage of new legislation to create a comprehensive framework for U.S. Food and Drug Administration regulation of “in vitro clinical tests,” a newly defined product category that would include both laboratory developed tests and other in vitro diagnostics.

The authors review key features of the newly proposed VALID Act of 2020, highlight changes in the bill from previous regulatory and legislative proposals for diagnostic reform, and discuss how the significant delay in the availability of COVID-19 diagnostics during the current pandemic is being used by the bill’s sponsors to illustrate the critical and immediate need for a complete overhaul of the regulatory framework for in vitro diagnostics. Whether the current crisis is able to move this complex legislative proposal forward in an accelerated time frame remains to be seen.