Senate HELP Committee approves more Cures-related bills

The Senate Health, Education, Labor and Pensions Committee today approved seven more bills for inclusion in an Innovations package, which could serve as a companion to the House-passed 21st Century Cures bill. The Medical Electronic Data Technology Enhancement for Consumer’s Health Act (S. 1101) would exclude from Food and Drug Administration regulation as a medical device most software used for electronic patient records; clinical laboratory testing; medical recommendations; or administrative, operational or financial records in health care settings. The other approved bills would add Zika virus to an FDA program that awards vouchers to sponsors of new drug and biological products (S. 2512), permanently extend the program to rare pediatric diseases (S. 1878), and address medical countermeasures (S. 2055), regulation of combination drug-device products (S.1767), drug packaging (S. 1597) and breakthrough medical devices (S. 1077). The committee last month approved for inclusion in the package legislation (S. 2511) aimed at making electronic health records more interoperable. It plans to mark up additional legislation on April 6 before bringing the package to the floor.