May 2010

Yes, We CAN: Healthcare Law Includes New NIH Grant Program

 

President Obama signed the new healthcare law in March, and, while most of the raucous year-long debate focused on costs, level of federal control over the economy, death panels, creeping socialism and other broad issues both real and imagined, a little-noticed provision is in the new law due to an amendment inserted in the bill last summer during Senate debate. The author was Sen. Arlen Specter, D-Pa., and the new National Institutes of Health program is called the “Cures Acceleration Network” or CAN.

If fully funded at the authorized level, the program will be a significant one: The authorization level is $500 million the first year, and at comparable amounts for the next decade.

The goal of CAN is to “award grants and contracts to eligible entities…to accelerate the development of high need cures, including through the development of medical products and behavioral therapies.” A “high need cure” is 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.”

CAN’s functions include conducting and supporting revolutionary advances in basic research and translating scientific discoveries from bench to bedside; awarding grants and contracts to eligible entities; providing the resources necessary for government agencies, private companies, academic institutions and investigators to develop high need cures and reducing the barriers between laboratory discoveries and clinical trials for new therapies.

The law also mandates an increasingly close relationship between the Food and Drug Administration and NIH. Another CAN function is to facilitate review in the FDA for the high need cures funded by CAN through activities such as regular and ongoing communication with FDA; assuring that such activities are coordinated with FDA approval requirements with the goal of expediting product development and approval and connecting interested individuals with FDA technical assistance programs.

A New Board

A CAN Board also will be established. The board will consist of 24 members serving four-year terms. At least one eminent individual in each of the following fields must be appointed to the board: basic research, medicine, biopharmaceuticals, discovery and delivery of medical products, bioinformatics and gene therapy, medical instrumentation and regulatory review and approval of medical products.

An additional four individuals from private venture capital firms also will be appointed, as well as eight representatives of disease advocacy organizations.

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