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June 2011
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NIH provides Congress with revised FY2012 budget proposal to account for NCATS
The National Institutes of Health (NIH) has released much-anticipated budgetary details for how it intends to launch a center for translational research by this fall.
The NIH first proposed the establishment of the new National Center for Advancing Translational Science (NCATS) in December as an entity to help bridge research and industry and speed promising discoveries through the drug development pipeline. It is a signature project of NIH Director Francis Collins, who is ardently pushing to have the center opened by October 1.
Some question the fast pace at which Collins is pursuing the project, along with whether it is appropriate for NIH to play a role in drug development. On the flipside, others in the community have come forward in support of the endeavor, agreeing with Collins that creating a focal point for translational research at NIH will help accelerate drug development, particularly for rare diseases.
One big area of contention stems from the fact that NCATS will require the dissolution of an existing center, the National Center for Research Resources (NCRR).
The specific organizational changes and realignment of resources are detailed in the newly revised NIH budget proposal for fiscal year 2012, which was sent to relevant Senate and House appropriators on June 6. If the changes are approved, they will need to be incorporated as the FY2012 spending bills are drafted this summer.
As expected, more than $553 million in programs from the $1.3 billion NCRR will be transferred to NCATS, including the Clinical and Translational Science Awards (CTSAs), while the rest of NCRR's programs will be distributed among other institutes, and to the office of the NIH director.
NCATS will also house the Therapeutics for Rare and Neglected Diseases program, currently under the National Human Genome Research Institute, the Office of Rare Disease Research, currently under the NIH Office of the Director, as well as the Cures Acceleration Network, a new office created through the recent health care reform law.
Whether Congress will embrace the plan remains to be seen. A handful of House members and key House aide have cast scrutiny over the proposal, and at a recent congressional hearing on the NIH budget, Sen. Richard Shelby (R-Ala.), the leading Republican on the Senate subcommittee that oversees the agency’s funding, raised questions about whether NCATS is the right approach.
The chair of that subcommittee, Sen. Tom Harkin (D-Iowa), has not yet indicated his position on the specifics of the new proposal.
In a June 6 letter to Harkin, Kathleen Sebelius, the secretary of Health and Human Services, NIH's parent agency, pointed out that the revised proposal does not ask for new money beyond the $31.7 billion that the administration has already requested for NIH in FY2012. She went on to emphasize that "NCATS is expected to offer innovative approaches to the development pipeline, provide novel approaches to diagnostics and therapeutics development, stimulate new avenues for basic scientific discovery, and complement existing NIH and private sector research."
Given the difficulty Congress had in finalizing the FY2011 budget, there is no telling when it might accomplish business for FY2012, meaning NIH may have a long wait before it can proceed with its plans to open the center.
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