Health Innovation in the Senate Continues

• On March 9, the Senate HELP Committee held its second health innovation executive session and passed a package of seven bipartisan bills.

• During the first executive session, held in February, the committee approved seven bills.

• HELP plans to hold a third and final executive session on April 6, and Senator Alexander is looking to finish the innovation bill quickly.

PROGRESS ON INNOVATION

The Senate HELP Committee is continuing work on its Biomedical Innovation Project, a complement to the House’s 21^st Century Cures initiative. At the first innovation executive session, the committee approved seven bills. Last week, the committee held a second executive session and approved an additional seven bills.

The committee will hold a third executive session on the innovation agenda on April 9.

“Today we marked up seven more bills incorporating about 15 more bipartisan proposals and that — with the seven bipartisan bills passed last month — gives a substantial start to our innovation companion to the 21^st Century legislation passed by the House of Representatives.” – Senator Alexander, 03-09-2016

S. 1878 The Advancing Hope Act of 2015

Senators Isakson, Kirk, Casey, and Brown. The bill extends and strengthens the current FDA pediatric rare disease priority review voucher program. It clarifies the definition of rare pediatric diseases so the treatment gap can be closed for all children with rare diseases; extends program eligibility to all pediatric cancers to encourage the development of life-saving innovations; and removes the sunset provision so the program will continue to be available to companies working to advance treatment options for children.

S. 1077 The Advancing Breakthrough Medical devices for patients Act of 2015

Senators Burr, Hatch, Bennet, and Donnelly. The bill ensures the FDA can help Americans benefit from the latest life-saving research and innovative devices developed by the medical community by providing a clear path by which innovations can get breakthrough devices to patients quickly. Specifically, the bill expedites the development and review of breakthrough products by enhancing existing tools to approve medical devices, such as priority review.

S. 1101 The Medical Electronic data Technology Act of 2015

Senators Hatch and Bennet. The bill provides certainty regarding the regulation of medical software by the FDA and helps boost innovation in health IT. It encourages medical software innovators to continue developing new technology to benefit health care professionals and patients. Specifically, the bill limits and clarifies FDA’s role regarding regulation of administrative and financial software, wellness and lifestyle products, certain aspects of electronic health records, data transfer software for laboratory test results, and software that aids health care providers in developing treatment recommendations for their patients.

S. 2055 The Medical Countermeasures Innovation Act of 2015

Senators Burr, Isakson, Roberts, Alexander and Casey. This bill encourages the development of medical countermeasures, including drugs, devices and preventative treatments, needed to protect the American people in the event of a global pandemic or biological weapon attack. Despite recent improvements in America’s readiness and response capabilities, the Ebola crisis, the Zika virus, and other emergencies at home and abroad make it clear that more needs to be done to ensure our government is fully capable of responding to these threats.

S. 1767 The Combination Products Innovation Act of 2015

Senators Isakson, Roberts, Toomey, Kirk, Cassidy, Casey, and Donnelly. This bill makes innovative medical treatments that currently do not fall under a single categorization – drug, device, biologic – for approval by the FDA available to patients through a streamlined, efficient regulatory pathway. Currently, combination products face delays in the FDA review process because they are often considered to be new products, even when they may present only incremental risk over previously approved or cleared products that have prior findings of safety and effectiveness, and the current device definition often allows for combination products to be incorrectly classified as drugs instead of devices leading to many misclassifications.

S. 1597 Patient Focused Impact Assessment Act of 2015

Senators Wicker, Collins, Isakson, Cotton, Murkowski, Klobuchar, Franken, Bennet, and Donnelly. This bill urges greater transparency of product approval at the FDA by requiring the development of a patient engagement assessment tool as well as new guidance on how patients may submit relevant data to the agency. Specifically, the bill requires the package of information published by the FDA upon approval of a new drug to include documentation of efforts to assess patient engagement. It helps ensure patients’ voices are heard throughout the development of new treatments.

S. 2512 Adding Zika Virus to the FDA Priority Review Voucher Program Act

Senators Isakson, Kirk, Portman, Franken, Nelson, Brown, Menendez, Casey, Murphy, Klobuchar, and Murray. This bill encourages companies to develop a treatment, cure or vaccine for the Zika virus. Specifically, the bill expands the tropical disease product priority review voucher program, which awards a voucher to the sponsor of a new drug or biological product that is approved to prevent or treat a tropical disease, to include the Zika virus. A voucher entitles the holder to have a future new drug or biological product application acted upon by the FDA within six months.