Health Innovation in the Senate

• On February 9, the Senate HELP Committee passed a package of seven bipartisan health innovation bills.

• The committee plans to hold two additional executive sessions – one in March and one in April – to discuss other health innovation bills.

• Senator Alexander said he intends a package of these biomedical innovation bills to be the Senate counterpart to the House-passed 21^st Century Cures bill, and hopes that the Senate and House products can be conferenced together this Congress.

MOTIVATION FOR INNOVATION

The Senate HELP Committee has been working on the Biomedical Innovation Project, a complement to the House’s 21^st Century Cures initiative. At an executive session on February 9, Chairman Alexander outlined the goals of the project:

“to get these cutting-edge drugs, medical devices, and treatments into Americans’ medicine cabinets and doctors’ offices more quickly at a lower cost without changing the standards for safe and effective approval. There has never been a more exciting time in medical research than now.” – Senator Alexander, 02-09-2016

The committee has held 10 hearings on the innovation project. At the first executive session on the project, the committee evaluated seven bills.

Senators Hatch, Bennet, and Warren. Help advance therapies to patients with serious or life-threatening rare genetic diseases by allowing innovators to rely on their own data used for previously approved targeted therapies to develop subsequent targeted therapies.

S. 1622 The FDA Device Accountability Act of 2015

Senators Burr and Franken. Attempt to ensure that Americans benefit from new medical devices more quickly by reducing unnecessary burdens in device evaluations and streamlining the review process for clinical trials. Additionally, this legislation modernizes the regulation of diagnostic tests, creating a clearer path for rapid diagnostics.

S. 2014 The Next Generation Researchers Act

Senators Collins and Baldwin. Help attract talented young scientists by promoting funding opportunities and helping to pay back student loans of young scientists at the National Institutes of Health.

S. 800 The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act

Senators Hatch, Murkowski, Isakson, Collins, Kirk, and Bennet. Promote rehabilitation research by ensuring the research plan for the National Center for Medical Rehabilitation Research is updated regularly and that it includes goals and objectives to facilitate research that will help the millions of Americans with disabilities, illnesses, and chronic conditions that require rehabilitation.

S. 849 The Advancing Research for Neurological Diseases Act of 2015

Senators Isakson and Murphy. Help advance our understanding of neurological diseases and help researchers to access data on these diseases in order to discover new therapies and cures.

S. 2503 THE Preventing Superbugs and Protecting Patients Act

Senator Murray. Further encourage and clarify that the FDA requires cleaning and validation data for reusable medical devices and to direct the FDA to clarify when device changes require regulatory clearance.

S. 2511 The Improving Health Information Technology Act

Senators Alexander and Murray. Improve health information technology for doctors and their patients. The bill promotes transparent ratings on usability and security to transform information technology; permits HHS to investigate and establish deterrents to information blocking practices that interfere with appropriate sharing of electronic health information; promotes interoperability; leverages health IT to improve patient care; and empowers patients by improving their access to their electronic health information.

MOVING FORWARD

The committee will hold a second executive session on the innovation agenda on March 9. At this session, the committee will consider the Advancing Hope Act of 2015, the Medical Electronic Data Technology Enhancement for Consumers’ Health Act, the Medical Countermeasures Innovation Act of 2015, the Combination Products Innovation Act of 2015, the Advancing Breakthrough Medical Devices for Patients Act of 2015, and legislation to support the president’s Precision Medicine Initiative and to ensure the NIH has the tools it needs to research treatments that are individualized for patients. A third markup is planned for April 6 to complete committee action on the innovation agenda.