The Senate Health, Education, Labor and Pensions (HELP) Committee approved seven bills this month that are intended to promote biomedical innovation, building on legislation approved by the panel in February. Specifically, on March 9, the Committee approved:
- S. 1878, the Advancing Hope Act of 2015 — to extend and expand an FDA priority review voucher program for rare pediatric diseases.
- S. 1077, the Advancing Breakthrough Medical Devices for Patients Act of 2015 – to expedite FDA review of all classes of breakthrough medical devices.
- S. 1101, the Medical Electronic Data Technology Enhancement for Consumers Health Act – to clarify FDA's role in regulating certain software used in health care settings and various wellness and lifestyle products.
- S. 2055, the Medical Countermeasures Innovation Act of 2015 – to encourage the development of medical countermeasures, including drugs, devices and preventative treatments, to address threats related to chemical, biological, radiological, or nuclear agents or emerging infectious diseases.
- S. 1767, the Combination Products Innovation Act of 2015 – to streamline and clarify the FDA approval/clearance process for sponsors of products that constitute a combination of a drug, device, or biological product.
- S. 1597, Patient Focused Impact Assessment Act of 2015 – to require FDA to develop patient-focused drug development tools and obtain patient perspectives on medical products under development.
- S. 2512 – to add the Zika virus to the FDA Priority Review Voucher Program that encourages treatments for tropical diseases. Note that this bill subsequently was approved by the full Senate on March 18, 2016.
The panel has scheduled a third markup for April 6 to complete committee action on the innovation package.
This article is presented for informational purposes only and is not intended to constitute legal advice.
