On Wednesday, the House Energy and Commerce committee released a draft bill for their 21st Century Cures Initiative. This is the second iteration of the proposal, following a lengthier version released in January. The legislation is designed to update regulations to help accelerate the development and approval of pharmaceuticals, medical devices and other medical innovations. The Energy and Commerce Health Subcommittee held a hearing on the bill yesterday. House leadership is seeking to have the bill considered by the full House in June, a quick turnaround for a bill that is yet to be fully fleshed out.

Under the threat of withdrawing Democratic support, the bill has been significantly pared down from its previous version and is now more favorable to generics over name-brand drugs. The earlier version included exclusive marketing perks for name-brands by providing 15 years of exclusivity for drugs that address an unmet medical need and another six months of exclusivity for drugs that treat rare diseases. Existing drugs would have also been eligible for additional exclusivity under the previous draft. The draft does include a new $2 billion innovation fund at the National Institutes of Health and supports precision medicine. Still to be hashed out between the parties are provisions on health information technology interoperability and data sharing and Medicare coverage of telehealth services. A summary of the bill is available here and a section by section summary of the draft is available here.

The Senate is also working on similar legislation to streamline the approval of medical innovations. On Monday, Senators Richard Burr (R-NC), Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduced S. 1077, the Advancing Breakthrough Devices for Patients Act, which would expedite the review and approval of breakthroughs in medical technology and devices.