Financing of U.S. Biomedical Research and New Drug Approvals across Therapeutic Areas

We estimated U.S. biomedical research funding across therapeutic areas, determined the association with disease burden, and evaluated new drug approvals that resulted from this investment.We calculated funding from 1995 to 2005 and totaled Food and Drug Administration approvals in eight therapeutic areas (cardiovascular, endocrine, gastrointestinal, genitourinary, HIV/AIDS, infectious disease excluding HIV, oncology, and respiratory) primarily using public data. We then calculated correlations between funding, published estimates of disease burden, and drug approvals. Financial support for biomedical research from 1995 to 2005 increased across all therapeutic areas between 43% and 369%. Industry was the principal funder of all areas except HIV/AIDS, infectious disease, and oncology, which were chiefly sponsored by the National Institutes of Health (NIH). Total (rho = 0.70; P = .03) and industry funding (rho = 0.69; P = .04) were correlated with projected disease burden in high income countries while NIH support (rho = 0.80; P = .01) was correlated with projected disease burden globally. From 1995 to 2005 the number of new approvals was flat or declined across therapeutic areas, and over an 8-year lag period, neither total nor industry funding was correlated with future approvals.Across therapeutic areas, biomedical research funding increased substantially, appears aligned with disease burden in high income countries, but is not linked to new drug approvals. The translational gap between funding and new therapies is affecting all of medicine, and remedies must include changes beyond additional financial investment

Correlation between a) total, b) industry, and c) NIH research funding in 2005 and projected disease burden in 2015 for high income countries and the world.

<p>Correlation between a) total, b) industry, and c) NIH research funding in 2005 and projected disease burden in 2015 for high income countries and the world.</p

New Molecular Entities Approved by US Food and Drug Administration by Therapeutic Area, 1995–2005.

<p>New Molecular Entities Approved by US Food and Drug Administration by Therapeutic Area, 1995–2005.</p

Research support, sponsors, and FDA new drug approvals from 1995 – 2005 for a) all therapeutic areas, b) neuroscience research, c) oncology research, d) cardiovascular research, and e) endocrine research.

<p>Research support, sponsors, and FDA new drug approvals from 1995 – 2005 for a) all therapeutic areas, b) neuroscience research, c) oncology research, d) cardiovascular research, and e) endocrine research.</p

Total Number of Drugs Approved by US Food and Drug Administration by Therapeutic Area, 1995–2005.

<p>Total Number of Drugs Approved by US Food and Drug Administration by Therapeutic Area, 1995–2005.</p

Funding for Biomedical Research by Therapeutic Area, 1995–2005.

*<p>Adjusted for inflation by the Biomedical Research and Development Price Index.</p

Research support, sponsors, and FDA new drug approvals from 1995 – 2005 for a) infectious disease (non-HIV) research, b) HIV research, c) gastrointestinal research, d) respiratory research, and e) genitourinary research.

<p>Research support, sponsors, and FDA new drug approvals from 1995 – 2005 for a) infectious disease (non-HIV) research, b) HIV research, c) gastrointestinal research, d) respiratory research, and e) genitourinary research.</p