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.
Finally, ex officio members will include a representative from the NIH, the Assistant Secretary of Defense for Health Affairs, the National Science Foundation and the FDA.
The Board will advise the NIH director on significant barriers to successful translation of basic science into clinical application. It also will provide recommendations to the director if such a barrier is identified. If the NIH director does not accept the recommendations, he or she must explain to the board why he or she has not done so.
The CAN will set up a series of grant programs designed to facilitate the development of high need cures that are in compliance with FDA standards regarding the drug development and approval process. Eligible entities include private or public research institutions, academic institutions, medical centers, biotechnology or pharmaceutical companies, disease or patient advocacy organizations and academic research institutions.
There are three types of awards. Cures Acceleration Partnership Awards provide up to $15 million per project for the first year in one lump sum. It appears that additional increments of up to $15 million can be applied for in subsequent fiscal years (not clear whether more than one additional year of funding is allowed). The recipient also must come up with nonfederal matching funds in a ratio of $1 for each $3 of federal funds received. The matching-fund requirement can be waived by the director.
Cures Acceleration Grant Awards also are funded at up to $15 million the first year, with at least one follow-up funding cycle with up to an additional $15 million possible. There is no matching requirement for this type of award.
Cures Acceleration Flexible Research Awards allow the NIH director to use “other transactions” besides contracts, grants or cooperative agreements to carry out the goals and objectives of the award program. No more than 20 percent of the total funds available for the CAN program can be spent in this manner, however.
Concerns have been expressed about the nature of this new program at NIH, and it will be interesting to learn more about what NIH officials think of it in the coming months. (We already are hearing rumblings that it is worrisome to certain IC directors, who wonder where the funding is going to come from in a tight money environment.) The main fear is that this program will become yet another unfunded mandate that NIH is expected to fund out of its existing budget. Another concern is that the program appears to be redundant: There already are programs at NIH designed to implement the goals of this program.
The new 24-member board sets up yet another bureaucratic structure to which the NIH director must report, and the membership seems heavily tilted away from traditional basic research. The trend is even more obvious by the requirement that NIH form a closer relationship with the FDA, which is not necessarily a bad thing, but it does seem to indicate a lessening of interest by Congress in NIH maintaining its historic focus on basic biomedical research.
Nevertheless, the CAN program is now enshrined into law, and the task of the biomedical research community is to make sure it functions in a way that is the least damaging to basic research. For starters, making sure that it is funded adequately with new money will be a goal in the coming year.
Peter Farnham (firstname.lastname@example.org) is director of public affairs at ASBMB.