Taking what is sure to be a step that is sure to raise controversy, the U.S. Government may be taking small steps towards getting into the drug development business. The news is bouncing around the internet after a recent article in the NY Times
As the cost and risk of drug development has increased, including tougher approval scrutiny, and a growing list of approved drugs that turn out to have safety issues, the drug-development pipeline from Big Pharma ist drying up. To spur new drug development, according to a recent report in the NY Times, the Obama administration is proposing a federal National Center for Advancing Translational Sciences (NCATS) within the National Institutes of Health (NIH).
According to Dr. Francis S. Collins, Director of NIH, “NCATS is not intended to be a drug company. It is a facilitator of translational research across the NIH and complementary to translational research already being conducted and supported on a large scale in the individual NIH Institutes and Centers. NCATS will seek ways to leverage science to bring new ideas and materials to the attention of industry by demonstrating their value.”
“The proposal for NCATS is that it will be assembled primarily from existing programs within the National Center for Research Resources (NCRR), the NIH Common Fund, and the National Human Genome Research Institute (NHGRI).” said Collins.
In an the FAQ on the new center the NIH says, ” Rapid progress in scientific research and the increased availability of innovative technologies have generated unprecedented potential for advancing the translation of basic discoveries into therapeutics. At the same time, the process of drug discovery remains a challenging and risk-laden endeavor. These opportunities and challenges have prompted the National Institutes of Health to propose formation of a new Center focused on accelerating the development and delivery of new, more effective therapeutics. This proposed Center is envisioned to be a tremendous resource for the entire translational science community. It would develop and offer innovative services and expertise in moving promising products through the development pipeline, as well as develop novel approaches to therapeutics development, stimulate new avenues for basic scientific discovery, and complement the strengths of existing NIH research activities.”
This sounds like a crossing the old boundry between the NIH and Big Pharma.
With respect to funding, “NCATS, if created, will use novel funding mechanisms to speed promising projects into the translational pipeline; reengineer aspects of the therapeutics development process; increase collaboration with FDA early in drug development; and enhance partnership between NIH, the private sector, and a broad range of stakeholders who are eager to see more therapeutics come to market.”
Again this sounds like blurring the old lines.
The proposal is a significant change from past practice, as such, it bears watching, and the din is sure to increase as stakeholders and politicians begin to weigh in.