The Department of Health and Human Services (HHS) this week gave Congress more budget details for a proposed National Institutes of Health (NIH) reorganization that would create a center devoted to bench-to-bedside research. A key budget document is still pending, however, and whether Congress will approve the center in time for it to launch in October remains unclear.
The plan announced in December for a National Center for Advancing Translational Sciences (NCATS) has raised concerns that NIH may be venturing too far into drug development. Many researchers have also been upset by NIH Director Francis Collins's decision to create NCATS in part by abolishing another component of NIH, the National Center for Research Resources (NCRR).
Some senators and a key House of Representatives staffer have questioned the reorganization. At a Senate hearing in April, Senator Richard Shelby (R-AL) complained that NIH had not yet submitted details of NCAT's budget.
HHS has now provided some of those details in a 6 June letter to the relevant Senate and House appropriations subcommittees. HHS Secretary Kathleen Sebelius explains that NCATs will "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."
An attached table describes how the new center will change the president's 2012 budget request. As expected, NCATS will get NCRR's $480 million Clinical and Translational Science Awards; NIH's $50 million Therapeutics for Rare and Neglected Diseases program, and the Cures Acceleration Network, which has no funding now but would get $100 million. NIH also now wants NCATS to house its $18 million Office of Rare Disease Research. Including other programs, NCAT's budget would be $722 million.
The table does not list a few program slated for NCATS that are now part of the NIH director's Common Fund, including the $100-some million Molecular Libraries. But those programs could remain part of the Common Fund but be administered by NCATS, according to an HHS official.
As for the rest of the $1.3 billion NCRR, the table closely matches a chart that NIH released in February. Among other changes, a large chunk of funding ($303 million) that includes primate centers and other comparative medicine programs would go to the NIH director's office. The National Institute of General Medical Sciences would get the $231 million IDEA awards and $97 million in biotechnology programs. NIH's minority health institute would take over the $60 million Research Centers in Minority Institutions.
The table doesn't give Congress what it really needs, however—a formal budget amendment from the White House Office of Budget and Management. Until that document is submitted, appropriations committee staffers can't include the reorganization in their draft bills for NIH's budget for the 2012 fiscal year that begins 1 October. And time is running out: The House subcommittee plans to mark up its bill on 26 July.