NIH Needs an Act of Congress to Get NCATS Up and Running
BioWorld Today Washington Editor
WASHINGTON – The likelihood that the National Center for Advancing Translational Sciences (NCATS) will open Oct. 1 as originally proposed is looking dim since the National Institutes of Health (NIH) still needs the go-ahead from Congress before it can launch the new center.
While the NIH recognizes the Oct. 1 opening date may not be realistic, "we are very optimistic that we will be able to create NCATS and get it up and running in the 2012 fiscal year," Kathy Hudson, deputy director for science, outreach and policy at the agency, told BioWorld Today.
Made up primarily of existing NIH programs, the new center would be a catalyst for developing a range of novel therapeutics. Rather than focusing on a specific disease group, NCATS will look for ways to improve the scientific process of drug discovery to identify better ways of testing and advancing promising therapies. (See BioWorld Today, Feb. 24, 2011, and June 28, 2011.)
In unveiling the center earlier this year, NIH Director Francis Collins envisioned NCATS as a collaborative effort that would transform the "valley of death" for experimental therapies into a "valley that leads to life" by:
validating many of the new drug targets that have emerged in the past few years, reducing the risk for companies looking to develop them;
validating questionable new compounds and biologics, getting them to a point where they could be handed off to a drug company for further development and commercialization;
re-examining drug candidates industry has dropped to see if they could be developed for other indications;
working with the FDA to develop a regulatory science agenda to accelerate the drug approval process and answering such questions as how to sufficiently test a drug intended to treat a rare disease that affects relatively few people;
enhancing training in relevant disciplines.
NCATS, as conceived, will include NIH programs such as the molecular libraries, Therapeutics for Rare and Neglected Diseases, Rapid Access to Interventional Development and Clinical and Translational Science Awards. It also will include the Cures Acceleration Network (CAN) provided by the Affordable Care Act, if it is funded.
Although the NIH has a detailed plan for the center, it needs Congress' approval to set it up. While such new programs are generally included in the president's budget, NCATS was not part of the 2012 budget President Barack Obama presented to Congress in February. (See BioWorld Today, Feb. 16, 2011.)
The budget did call for $700 million for existing NIH programs that could be used to fund NCATS, Collins said when he announced the new center. It also included $100 million in new funding for CAN. Collins expected the administration to offer a budget amendment for the new center.
However, Congress has yet to pass a fiscal 2012 budget. Since the current fiscal year ends Sept. 30, lawmakers may once again have to resort to a continuing resolution to keep the government running in lieu of a budget.
If that's the case, the NIH hopes to get an "anomaly" included in the continuing resolution that would allow NCATS to open and the other centers to be rolled into it, Hudson said. But if Congress passes a short-term resolution, it's not likely to include the NCATS amendment.
Meanwhile, the NIH is preparing for more budget cuts. Its 2011 funding, provided through a series of continuing resolutions, was about $300 million less than it had received in 2010, marking the second time in its history that the agency had an actual cut, Hudson said.
Despite the cut, NIH breathed a sigh of relief because the reduction was a "paper cut rather than a deep puncture wound," she said, adding that a House bill had proposed a more severe 5 percent cut with proscriptive measures that would have affected the size and number of grant awards.
The wound could be deeper for 2012 as the government approaches a crisis situation in terms of its investment in research. "It's a very unnerving time for people to look at a budget landscape that's so unsteady," Hudson said, referring to researchers who need government awards to help fund R&D for new interventions, cures and diagnostics.
As a result, "we have to figure out how to do business in new innovative ways to make every dollar go further," she added.
FDA Sets Fees for Priority Review Vouchers
Biopharma companies wanting to use a tropical disease priority review voucher in fiscal 2012 will have to pay nearly $5.3 million, in addition to the PDUFA user fee, for the privilege.
The FDA sets the voucher user fee each year based on the cost of conducting a priority review of a new drug or biologic, minus the PDUFA fee. It estimated that cost for fiscal 2011 at more than $7.1 million. The 2012 PDUFA fee is more than $1.8 million.
Under the incentive program, drugmakers that develop treatments for certain tropical diseases are awarded a voucher for a priority review that they can use for another product or transfer to another company.
Code Names Cracked on Orphan Drug Database
The FDA has dropped the code names used on its orphan drug database for a small subset of drugs that had no trade or generic name. The codes have been replaced with descriptive identifiers so the public can more easily identify the drugs.
Published: August 31, 2011
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