21st Century Cures draft proposes wide reforms

The U.S. House Energy & Commerce Committee released a discussion draft Tuesday of 21st Century Cures legislation that proposes sweeping changes to FDA regulation of drugs, medical devices, clinical research and reimbursement.

The draft includes a provision allowing FDA to approve a drug with breakthrough designation on the basis of a single Phase II study, contingent on postmarket clinical trials and/or data from observational studies and registries. FDA could withdraw breakthrough approvals if sponsors failed to provide the required data, if evidence emerged showing the drug was not safe or effective, or if the sponsor disseminated false or misleading promotional material. ...