May 11 2011

NCATS Program Needs Further Study

U.S. Senator Richard Shelby (R-AL), ranking Republican on the Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (Labor/HHS), today made the following statement at a committee hearing to examine the Fiscal Year 2012 Budget Request for the National Institutes of Health.

Excerpts of Shelby’s statement are immediately below in bold, followed by the full text of his prepared remarks:

I support federal investment in basic biomedical research and development.  Research carried out by the NIH and its network of 325,000 researchers at 3,000 institutions across the country serves the nation with the goal of improving human health. 

“As research becomes more expensive and private capital dries up, it is critical to ensure support for translational research – that is, research that moves a potential therapy from development to the market.  The NIH has developed an interesting proposal with the establishment of the National Center for Advancing Translational Sciences (NCATS) program.  NCATS is intended to fill the gap between advances in scientific understanding of disease and the process to turn new scientific insights into products. 

“The question remains, however, as to whether NCATS is the right approach to solving this issue.  Will NCATS be the right mechanism for taking valuable discoveries that the taxpayer has funded and giving it a greater opportunity to make it into the marketplace?  As we review this proposal, we need to consider the fact that NIH is not a drug developer or an expert in the therapeutics world.

“I believe that NCATS is a matter we should contemplate, but we must ensure that the steps forward are measured and in the best interest of all stakeholders.”

OPENING STATEMENT OF SENATOR RICHARD C. SHELBY
Fiscal Year 2012 NIH Hearing
May 11, 2011

“Mr. Chairman, thank you.  I appreciate you holding this hearing today to discuss the vital mission carried out by the National Institutes of Health. 

“We live in a world where there are thousands of debilitating and life-threatening diseases – all that could use additional funding for research and clinical trials.  I support federal investment in basic biomedical research and development.  Research carried out by the NIH and its network of 325,000 researchers at 3,000 institutions across the country serves the nation with the goal of improving human health. 

“As research becomes more expensive and private capital dries up, it is critical to ensure support for translational research – that is, research that moves a potential therapy from development to the market.  The NIH has developed an interesting proposal with the establishment of the National Center for Advancing Translational Sciences (NCATS) program.  NCATS is intended to fill the gap between advances in scientific understanding of disease and the process to turn new scientific insights into products. 

“I believe the need for an entity to straddle the worlds of research and industry is clear.  In the private market, pharmaceutical companies will abandon drug development projects that are not initially successful, become too complex, or do not provide a lucrative path forward.  For example, since 1949 there have only been two major drug discoveries in mental health – lithium and Thorazine. 

“Sixty years later, researchers still do not know why these drugs actually work.  Hundreds of genes have been shown to play roles in mental illness – too many for focused efforts by drug developers.  Therefore, many drug manufactures have dropped out of the mental health field. 

“In particular, pharmaceuticals for rare and neglected diseases are often ignored because private companies avoid this small market with little profit appeal, leaving patients with no treatment options.  Even promising new drugs discovered through basic research often struggle during the translational stage of the process because it is expensive, time-consuming, and prone to failure.  These barriers inhibit both the scientists dedicated to improving health and the patients who ultimately need improved cures and care.

“The question remains, however, as to whether NCATS is the right approach to solving this issue.  Will NCATS be the right mechanism for taking valuable discoveries that the taxpayer has funded and giving it a greater opportunity to make it into the marketplace?  As we review this proposal, we need to consider the fact that NIH is not a drug developer or an expert in the therapeutics world. 

“Dr. Collins, I would like to continue to work with you to make a thoughtful, informed decision regarding NCATS.  Unfortunately, the fiscal year 2012 budget request does not provide adequate details on the reorganization.  It is May 11th, and we have not received a budget amendment or specific structural details on NCATS – a program NIH wants to implement by October 1st.  How can the Subcommittee be expected to support a program that does not yet exist in budget documents?

“I understand that the transition from basic research to clinical application requires interdisciplinary and multidisciplinary expertise.  Research that aims to transform science is inherently difficult.  If it were easy the need for transformation would not exist.  NCATS may be the answer to solve this complex issue.  But it also may not.

“Dr. Collins, I believe that NCATS is a matter we should contemplate, but we must ensure that the steps forward are measured and in the best interest of all stakeholders, especially those who are in need of treatment and care.  I look forward to working with you and the Chairman on this important issue. 

“Thank you, Mr. Chairman.”