Michael Werner is a Partner in our Washington D.C. office.
A little-noticed provision buried in the Senate health reform bill's 2,400 pages could have a dramatic impact on the ability of companies, medical centers and research institutions to perform medical research, especially on products for rare diseases and other currently unmet medical needs.
Specifically, the bill creates a new Cures Acceleration Network (CAN) within the U.S. National Institutes of Health (NIH) to accelerate development of "high need cures" (defined as a product that "is a priority to diagnose, mitigate, prevent, or treat harm from any disease or condition and for which the incentives of the commercial market are unlikely to result in its adequate or timely development"). The bill authorizes $500 million for grants, contracts and awards.
Potential grantees include: public or private research institutions, medical centers, biotechnology and pharmaceutical companies, patient advocacy groups, disease advocacy organizations and others.
The purpose of the CAN is to:
- conduct and support basic and translational research
- award grants and contracts to develop cures
- reduce the barriers between laboratory discoveries and clinical trials for new therapies
- facilitate review in the U.S. Food and Drug Administration (FDA) for the high need cures funded by the CAN, through activities that may include:
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- the facilitation of regular and ongoing communication with the FDA regarding the status of activities conducted under this section
- ensuring that such activities are coordinated with the approval requirements of the FDA, with the goal of expediting the development and approval of countermeasures and products
- connecting interested persons with additional technical assistance
Funds are designed to:
- promote innovation in technologies supporting the advanced research and development, and production of high need cures, including through the development of medical products and behavioral therapies
- accelerate the development of high need cures, including through the development of medical products, behavioral therapies and biomarkers that demonstrate the safety or effectiveness of medical products
- help the award recipient establish protocols that comply with FDA standards and otherwise permit the recipient to meet regulatory requirements at all stages of development, manufacturing, review, approval and safety surveillance of a medical product
The legislation creates a board with 24 members to oversee the CAN and report to the NIH director. The board is required to be diverse and include representatives with expertise in basic research; drug development; private financing (recognized leaders in professional venture capital or private equity investing); disease advocacy groups; and others. Also included as ex officio members are representatives from government agencies such as NIH, HHS, AHRQ, VA, DoD and NSF.
The board will advise and provide recommendations to the NIH director regarding grant awards, and submit reports identifying significant barriers to successful translation of basic science into clinical application. The NIH director is required to respond to the board's recommendations, including the steps he will take to implement board suggestions.
The program is authorized for $500 million but the money will have to be provided through the annual appropriations process. According to the legislation, awards will be capped at $15 million for the first year of the award, but entities can apply for additional money in future years. The legislation creates several types of grants; one requires a grantee to provide matching funds of $1 for every $3 received from the federal government.
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