House E&C Seeks Quick Advice On FDA's LDT Role As It Drafts Cures Bill

The House Energy and Commerce Committee this week asked stakeholders to provide detailed feedback by Jan. 5 on key issues surrounding FDA's controversial plan to regulate laboratory developed tests, including ways Congress potentially could step in to shape FDA and CMS' regulatory roles over LDTs as part of the committee's soon-to-be-released draft 21st Century Cures legislation. In a white paper distributed Tuesday (Dec. 9), E&C lawmakers point out that FDA issued a framework to “fundamentally alter the regulatory landscape” of...