Senate HELP Committee approves final bills for medical innovation package

The Senate Health, Education, Labor and Pensions Committee today approved the last five in a package of bipartisan bills expected to serve as a companion to the House-passed 21st Century Cures Act. Today’s bills include provisions aimed at helping the National Institutes of Health and Food and Drug Administration hire and retain talent (S. 2700); approving antibacterial drugs to treat serious medical conditions in limited populations (S. 185); implementing a Precision Medicine Initiative (S. 2713); promoting the inclusion of minorities in clinical research (S. 2745); and streamlining administrative requirements for NIH researchers and grant recipients (S. 2742). Committee Chairman Lamar Alexander (R-TN) said senators continue to negotiate an NIH innovation fund as part of the package, which also includes legislation aimed at making electronic health records more interoperable (S. 2511); requiring makers of reusable medical devices such as duodenoscopes to submit proposed cleaning instructions and validation data to the FDA before marketing (S. 2503); and excluding from FDA regulation as medical devices most software used for electronic patient records (S. 1101). Commenting on S. 2511 in February, AHA expressed concern with the bill’s information blocking provisions and recommended additional actions to improve interoperability.