Navigation Links
The respective roles of the public and private sectors in pharmaceutical innovation

NEW YORK -- Research conducted by Columbia Business School Professor Frank Lichtenberg, Courtney C. Brown Professor of Business, Finance and Economics, Healthcare and Pharmaceutical Management Program, and Bhaven Sampat, Assistant Professor in the Department of Health Policy and Management at the Mailman School of Public Health of Columbia University, identifies the respective contributions of direct and indirect government support in research and development of new pharmaceutical drugs. Although industry supplies the bulk of the funds devoted to research and development, the public sector primarily the National Institutes of Health (NIH) supports most of the nation's basic biomedical research. The research, recently featured in Health Affairs, finds direct government funding to be important to research and development for the most innovative new drugs, which typically proceed through the Food and Drug Administration's (FDA) "priority-review" process for approval. However, direct government funding is less important for research and development of so-called standard-review drugs that proceed through the FDA's normal review process. The researchers' analysis can help determine the merits of various policy proposals, such as those that would attempt to recapture a share of drug profits and return them to the government through recoupment or march-in authority. March-in proposes that taxpayers should not have to pay twice for publicly funded research once through taxes, and once through monopoly prices or restricted access to drugs.

The paper focuses on patents for drugs approved between 1988 and 2005. The analysis studies a range of publicly available data from federal agencies including the Patent and Trademark Office, the National Library of Medicine, the FDA, and the Agency for Healthcare Research and Quality (AHRQ). Of the 478 drugs in the sample, 379 were covered by at least one patent. There were 1,073 distinct patents on these 379 drugs.. The researchers identified public-sector patents to be ones assigned to a government agency, which generally resulted from research conducted inside that agency, and all of those with government interest statements. Most derived from academic laboratories that had received government funding, generally through extramural research grants. The recipients of federal research grants are required to acknowledge government funding in their patent applications.

The researchers' analysis found striking differences between priority-review drugs and standard-review drugs in terms of the proportion receiving a public-sector patent. The direct government role is much more pronounced for the most innovative drugsthose receiving priority review. The data also show that the indirect impact of government funding is much larger than the direct effect. Although fewer than 10 percent of drugs had a public-sector patent, far larger proportions of drugs had patents that cited a public-sector patent, a government publication, or both. In all cases, the public-sector influence was much greater on priority-review drugs than on those receiving a standard review.

Professor Lichtenberg explains the significance of the study. "This analysis underscores why it is important to distinguish between the direct and indirect roles of government funding in pharmaceutical innovation. For example, policies such as recoupment and march-in would apply only to drugs in whose development the government had played a direct role."

Contact: Sona Rai
Columbia Business School

Related biology technology :

1. Sigma-Aldrich (Nasdaq: SIAL) Reports Q4 and Full Year 2010 Diluted EPS of $0.76 and $3.12, Respectively. Q4 and Full Year 2010 Adjusted Diluted EPS Were $0.83 and $3.31, Respectively. Q4 Sales Set New Quarterly High. 2011 Diluted EPS Expected to be
2. Sigma-Aldrich (Nasdaq: SIAL) Reports Q3 2010 Diluted EPS of $0.76. Diluted EPS Increased by 9% and 19% on a Reported and Adjusted Basis, Respectively. Q3 Sales Performance Remains Strong; Full Year 2010 Diluted Adjusted EPS Outlook Raised to $3.20 -
3. Enerkem adds two new executive roles to growing North American presence
4. Wireless Health 2010 Explores the Roles of Wireless Technologies in Clinical Services
5. Chandler Chicco Companies Acquires Haas & Health Partner Public Relations and SanCom Creative Communication Solutions, Creating Unrivalled Healthcare Communication Capability in Germany
6. Two Top Biological Imaging Centers Offer Powerful Free Online Tool to Researchers, Educators, and Public
7. Nutra Pharma Announces Publication of a New Mechanism Study of Alpha-Cobratoxin in the Treatment of Pain
8. Clionsky Neuro Systems (CNS-Neuro) Announces Publication of Study Finding Elderly Patients Unable to Recognize Their Memory Loss
9. Northwest Bio Announces Interview of CEO Linda Powers in Todays CEO/CFO Publication
10. United States Holds Global Lead in Breast Cancer Research Publications as China Surges to Forefront, According to Report
11. Pfizer, Sanofi and Genentech Feature Prominently in the Oncology Edition of PharmaDeals New Publication Series; Essential Deal Trends
Post Your Comments:
(Date:6/23/2016)... , June, 23, 2016  The Biodesign Challenge ... envision new ways to harness living systems and biotechnology, ... Art (MoMA) in New York City ... 130 participating students, showcased projects at MoMA,s Celeste Bartos ... Paola Antonelli , MoMA,s senior curator of architecture and ...
(Date:6/23/2016)... ... 2016 , ... Supplyframe, the Industry Network for electronics hardware ... . Located in Pasadena, Calif., the Design Lab’s mission is to bring together ... built and brought to market. , The Design Lab is Supplyframe’s physical representation ...
(Date:6/23/2016)... ... , ... In a new case report published today in STEM CELLS Translational ... lymphedema after being treated for breast cancer benefitted from an injection of stem cells ... this debilitating, frequent side effect of cancer treatment. , Lymphedema refers to ...
(Date:6/23/2016)... 23, 2016  Blueprint Bio, a company dedicated to ... medical community, has closed its Series A funding round, ... "We have received a commitment from Forentis ... need to meet our current goals," stated Matthew ... runway to complete validation on the current projects in ...
Breaking Biology Technology:
(Date:6/1/2016)... June 1, 2016 Favorable Government ... Administration and Criminal Identification to Boost Global Biometrics System ... released TechSci Research report, " Global Biometrics Market ... Forecast and Opportunities, 2011 - 2021", the global biometrics ... 2021, on account of growing security concerns across various ...
(Date:5/9/2016)... 2016 Elevay is currently known ... freedom for high net worth professionals seeking travel for ... connected world, there is still no substitute for a ... sealing your deal with a firm handshake. This is ... advantage of citizenship via investment programs like those offered ...
(Date:4/26/2016)... DUBLIN , April 27, 2016 ... of the  "Global Multi-modal Biometrics Market 2016-2020"  report ... ) , The analysts forecast ... a CAGR of 15.49% during the period 2016-2020.  ... a number of sectors such as the healthcare, ...
Breaking Biology News(10 mins):