Navigation Links
How do data exclusivity periods affect pharmaceutical innovation?
Date:1/6/2011

LOS ANGELES, Calif. January 6, 2011 Pharmaceutical companies and generic drug manufacturers have long been at odds over regulations about "data exclusivity," the period of time before generic manufacturers can make use of valuable clinical trial data.

A new study in the January 2011 issue of Health Affairs is the first to calculate the financial and social costs of limiting access to trial data and finds that extending the term of exclusive access will lead to higher drug costs in the short term but also to more than 200 extra drug approvals and to greater life expectancy in the next several decades.

"Elected officials are unlikely to embrace legislation that would result in higher drug prices, but our research suggests that legislation to extend data exclusivity would spur innovation that would benefit future generations," explained Dana Goldman, lead author, director of the Schaeffer Center for Health Policy and Economics at USC and Norman Topping Chair in Medicine and Public Policy at USC.

The pharmaceutical companies that introduce new drugs are currently granted five years of exclusive access to the clinical trial data they submit during the approval process. An extension of three years is available if new applications arise and a six month extension is granted if the drug is approved for use in pediatric populations.

In 2007, the National Academies Committee on Science, Engineering and Public Policy called for extending this "data exclusivity" term to the longer period used in Europe, ten to 11 years. But generic manufacturers have argued for shorter limits so that they can bring less expensive versions of drugs to patients sooner.

"Unfortunately, the health policy literature contains no information about the effects such a policy would have on innovation, population longevity and social welfare," said Darius Lakdawalla, research director at the Schaeffer Center at USC and associate professor in the USC School of Policy, Planning and Development.

In the first study to directly address these issues, the researchers estimate that extending the term of data exclusivity to 12 years would increase the lifetime revenue of a drug by 5 percent, on average.

With empirical evidence that profits drive drug innovation, this longer term would lead to an additional 228 drug approvals over the next fifty years and an increase of 1.7 months in average life expectancy, according to the study.

John Romley, an economist with the Schaeffer Center at USC and research assistant professor at the USC School of Policy, Planning and Development, acknowledged the trade-off between current and future generations: "Americans in the early 2020's would bear the cost of increasing drug spending. However, people turning 55 in 2060 could expect increased life expectancy as a result of innovation in the interceding years that is, new drugs brought to market because of lengthier data exclusivity."


'/>"/>

Contact: Suzanne Wu
suzanne.wu@usc.edu
213-740-0252
University of Southern California
Source:Eurekalert

Related medicine news :

1. Gene Activity May Affect Acute Myeloid Leukemia Outcome
2. Vitamin D and parathyroid hormone levels may not affect cardiovascular mortality
3. Depression During Pregnancy Might Affect Baby
4. How MS Affects Kids May Differ by Race
5. Marital Status May Affect Kidney Transplant Decision
6. Research Finds Not All HIV Affects Immune System Same Way
7. Working With Pesticides May Affect Memory and More
8. Sleepless soldiers: Study suggests that military deployment affects sleep patterns
9. Trust in Doctor May Affect Reaction to Medical Error
10. Too Much Hygiene May Affect Immune System, Study Suggests
11. Social Class May Affect Outcome of Depression Treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2016)... Harrisburg, PA (PRWEB) , ... May 04, 2016 , ... ... Commonwealth recently convened in the state capitol for the annual “Hike to Harrisburg” advocacy ... Society (PATS) and The Winter Group, PATS lobby Group. The goal for the ...
(Date:5/3/2016)... (PRWEB) , ... May 04, 2016 , ... ... than 40 national and global construction firms representing the Construction Industry Safety Initiative ... joined forces with one purpose: to inspire everyone in the industry to be ...
(Date:5/3/2016)... ... May 03, 2016 , ... In April, Amerec launched a new website ... help find the best steam and sauna solutions. , First, the Amerec website has ... improvement brings all of the site’s features, especially the Steam Builder Tool , ...
(Date:5/3/2016)... Irvine, California (PRWEB) , ... May 03, 2016 ... ... of its innovative brainsalvation tool – a web application that helps people assess ... medical research, the brainsalvation™ web app will provide users a “Risk Reduction Score™” ...
(Date:5/3/2016)... NJ (PRWEB) , ... May 03, 2016 , ... ... BCBSNJ) today announced that it has been honored as one of the nation’s ... the 2016 InformationWeek Elite 100. Horizon received the recognition for technology achievements that ...
Breaking Medicine News(10 mins):
(Date:5/3/2016)... YORK , May 3, 2016 ... (MRI) Market Size, Share, Development, Growth and Demand Forecast ... Open), by Field Strength (High Field, Very High Field, ... Application (Brain, Head and Neck, Spine, Musculoskeletal, Vascular, Breast, ... the global magnetic resonance imaging (MRI) market was valued ...
(Date:5/3/2016)... 3, 2016 Global and ... a basic overview of the industry that covers ... surgical mesh report explores into the international and ... report on Surgical Mesh market spread across 150 ... and figures is available at http://www.reportsnreports.com/reports/470569-global-and-chinese-surgical-mesh-industry-2016-market-research-report.html ...
(Date:5/2/2016)... 2016  Deerfield announced today it led the ... Inc. Graybug Vision is an early stage pharmaceutical ... care for ocular diseases including wet age-related macular ... first developed at Johns Hopkins University and has ... Graybug Vision is developing ophthalmology products ...
Breaking Medicine Technology: