After a decade of remarkable growth, total annual funding for biomedical research in the U.S. has decelerated and may have even fallen when adjusted for inflation. That is the conclusion of a study today published in the Journal of the American Medical Association.
"The era of rapid expansion in biomedical research funding that began in the 1990's has ended," said Ray Dorsey, M.D., a neurologist at the University of Rochester Medical Center and lead author of the study. "Looking back at this period, one of the striking observations is that while research funding increased, the number of novel treatments entering the market remained steady. If research funding levels are to return to a phase of growth, we should examine funding priorities, particularly in health services research, and barriers to the development of new therapies."
The authors compiled data from government sources, trade organizations, and industry financial reports to create a profile of biomedical research funding from 2003 to 2007. Over the five year period, annual research funding increased from $75.5 to $101.1 billion. Adjusted for inflation, funding grew by an average annual rate of 3.4% over the period. Using incomplete data, the authors estimated research funding from the National Institutes of Health (NIH) and industry for 2008 at $88.8 billion, which, when adjusted for inflation, represents a decrease in funding.
The study is a follow-up to a similar analysis published in 2005 by the same authors that showed that biomedical research funding from all sources had tripled in nominal value and doubled when adjusted for inflation between 1994 and 2003. The annual growth rate in funding over the period was more than twice as fast at 7.8%.
This deceleration in funding, if unchanged, has a significant potential impact for the biotechnology and pharmaceutical industries and academic research institutions that rely on government and private funding. As has been noted in other reports, the flat-lining of federal funding for biomedical research in particular has a cascading effect on the national academic research enterprise, leading to scientists spending more of their time chasing funding, influencing career choices of new graduates, discouraging higher risk research, and curtailing the establishment of new scientific programs and construction of new research facilities.
The growth in research funding that began in the 1990s fueled a significant expansion in academic research and many universities became engines for economic growth in their communities. Consequently, the deceleration in research funding could have a profound effect on communities where academic research, health care, and biotechnology have become major economic players.
Approval of New Drugs and Devices Stagnant
While funding has generally increased over the period examined, this growth has not been accompanied by an increase in the number of new drug and device approvals by the U.S. Food and Drug Administration (FDA). For example, the number of new molecular entities, essentially drugs that have not been marketed in the U.S. previously, approved by the FDA in 2003 was 21 and in 2008 was 17. Similar trends were observed for new biologics, as measured by biologic license applications, and devices, as measured by device pre-market application approvals.
"The relative lack of new therapeutic advances has been a decade-long problem that continues to persist despite previous large investments in research funding," said Dorsey. "The current model is not working well if the desire is to approve new novel therapies to improve health. We need to modify incentives to reward risk and increase support for companies pursuing early stage and innovative research."