On Wednesday, the Massachusetts House voted 113-40 to pass its recently released transportation funding package. This package would raise roughly $600 million through increased fees and taxes to help provide the resources necessary to address the current status of our roads, bridges, and the MBTA. It also appropriates approximately $14.4 billion in transportation-related capital projects.
Also last week, the Executive Office of Health and Human Services (EOHHS) released its final regulations relative to Drug Manufacturer Negotiations and Accountability, 101 CMR 801.00, as authorized by the FY2020 budget. Through these regulations HHS has the authority to directly negotiate for supplemental rebates with a drug manufacturer; to determine a target value for any high-cost drug that was the subject of a failed negotiation; and may refer a manufacturer to the Massachusetts Health Policy Commission (HPC) if no supplemental rebate agreements are agreed upon. While the final regulations don’t differ greatly from the ones initially proposed, the final regulations have positive changes about what criteria will be used to determine drug value. They also extend the time from 14 days to 30 days the time EOHHS must wait before sending a letter about failed negotiations.
The United States House of Representatives passed an $8.3 billion bipartisan spending bill aimed at fighting the coronavirus outbreak. While numerous biotech companies in Massachusetts and beyond have already begun developing vaccines and therapies, this bill will help fund the research and testing needed to augment efforts to stop the spread of the virus.
On Monday, MassBio and Bayer announced the Center for Regulatory Excellence, a first-of-its-kind forum for startups and academia to interact with and learn from regulatory experts. The Center will provide formal mentorship and regular seminars to ensure early identification and mitigation of regulatory issues and optimize the chances of regulatory success.