From Nature magazine

Francis Collins, director of the U.S. National Institutes of Health (NIH), is in danger of missing a self-imposed deadline for his hallmark priority: establishing an NIH center dedicated to speeding new treatments from the lab to the clinic.

Collins vowed that the $723-million National Center for Advancing Translational Sciences (NCATS) would be up and running on 1 October — in time for him to oversee its first year in operation. (Should Republicans capture the White House in November 2012, Collins could be out of a job.) But Congress must explicitly approve it in a 2012 spending bill — a document that has yet to be written and which the distracted, highly polarized body seems unlikely to pass before the new fiscal year begins on 1 October.

So the NIH and the administration are developing a plan B: drafting an 'anomaly' that would allow the translational-medicine center to launch on a reduced budget. The anomaly would be part of a stop-gap law, known as a continuing resolution, that keeps the government funded at 2011 levels while law-makers finish drawing up 2012 spending bills.

As to whether the maneuver will work, Kathy Hudson, the NIH deputy director for science, outreach and policy, says "we're optimistic". But the bar for an anomaly on a stop-gap funding bill can be high. Anomalies are usually limited to urgent matters such as emergency services that are set to expire and can't wait for a regular spending bill. The NIH's rush to launch the center has also come up against vocal opposition from Denny Rehberg (Republican, Montana), who chairs the House spending subcommittee that funds the NIH and who in June demanded more details from the agency about its plans. (He has since received them.) Rehberg's position gives him significant, but not insuperable power; and NCATS' ultimate goal of speeding cures to patients is a popular one in Congress.

However, the fact remains that NCATS needs affirmative attention from a preoccupied Congress. "We're keenly aware that we need to have a line item for NCATS — that it does need to be expressly written into appropriations language," says Margaret Anderson, the executive director of FasterCures, a think tank in Washington DC that focuses on speeding new therapies.

Collins, who early in his tenure declared translational medicine to be one of his top priorities, has pushed hard for the creation of the center, which would focus on accelerating and improving the process of drug and device development. He first encountered resistance on the NIH campus, when it became clear that setting up the center would mean dismantling and dividing up the pieces of the National Center for Research Resources, a $1.3-billion NIH institute devoted to infrastructure and training. In Congress, Rehberg and others have questioned whether the agency is pushing the government into an area — drug development — that they say should be the preserve of industry. Collins has said that NCATS will "complement — not compete with" the private sector.

On 15 June, after Collins announced a search for a director of the new center, Rehberg wrote to Kathleen Sebelius, who heads the Department of Health and Human Services, the NIH's parent agency, pronouncing himself "very troubled" by the search. Without an official budget amendment outlining the financing of the center and explaining other details of the NIH's plans that would "allow us to review the proposal fully", Rehberg wrote, "we cannot responsibly take any action on this matter".

Under the Freedom of Information Act,Nature has obtained Sebelius's 6 July response to Rehberg's letter, which ran, with attachments, to 79 pages of minute detail about the structure, finances and goals of the proposed center (see In her covering letter, Sebelius told Rehberg that the NIH has confined itself to "preliminary planning" with the aim of an efficient launch in 2012, and adds that the agency will not hire a director "until NCATS is established". Rehberg has not responded to multiple requests for comment over the 12 weeks since he wrote to Sebelius.

But Congress's broader budget troubles seem as likely to delay NCATS as the skirmish with Rehberg. David Moore, a veteran congressional observer and senior director for governmental relations at the Association of American Medical Colleges in Washington DC, says that the increasingly charged atmosphere around spending issues on Capitol Hill makes it impossible to predict the chances of Congress passing a bill — whether a stop gap measure or a full 2012 law — in time for NCATS to launch on 1 October. "We think it's going to happen. We just don't know how or when," he says.

This article is reproduced with permission from Nature magazine. The article was first published on September 5, 2011.