Featured Research

from universities, journals, and other organizations

How do data exclusivity periods affect pharmaceutical innovation?

Date:
January 6, 2011
Source:
University of Southern California
Summary:
A new study 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.

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.

Related Articles


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."

Jesse D. Malkin at Precision Health Economics and Tomas Philipson of the University of Chicago are also authors on the study. The research was sponsored by the National Institute on Aging through its support of the Roybal Center for Health Policy Simulation and INTERPAT, an association of research-based pharmaceutical companies.


Story Source:

The above story is based on materials provided by University of Southern California. Note: Materials may be edited for content and length.


Journal Reference:

  1. Goldman et al. The Benefits from Giving Makers of Conventional 'Small Molecule' Drugs Longer Exclusivity Over Clinical Trial Data. Health Affairs, January 2011

Cite This Page:

University of Southern California. "How do data exclusivity periods affect pharmaceutical innovation?." ScienceDaily. ScienceDaily, 6 January 2011. <www.sciencedaily.com/releases/2011/01/110106164618.htm>.
University of Southern California. (2011, January 6). How do data exclusivity periods affect pharmaceutical innovation?. ScienceDaily. Retrieved November 28, 2014 from www.sciencedaily.com/releases/2011/01/110106164618.htm
University of Southern California. "How do data exclusivity periods affect pharmaceutical innovation?." ScienceDaily. www.sciencedaily.com/releases/2011/01/110106164618.htm (accessed November 28, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Friday, November 28, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Ebola Leaves Orphans Alone in Sierra Leone

Ebola Leaves Orphans Alone in Sierra Leone

AFP (Nov. 27, 2014) — The Ebola epidemic sweeping Sierra Leone is having a profound effect on the country's children, many of whom have been left without any family members to support them. Duration: 01:02 Video provided by AFP
Powered by NewsLook.com
Experimental Ebola Vaccine Shows Promise In Human Trial

Experimental Ebola Vaccine Shows Promise In Human Trial

Newsy (Nov. 27, 2014) — A recent test of a prototype Ebola vaccine generated an immune response to the disease in subjects. Video provided by Newsy
Powered by NewsLook.com
Pet Dogs to Be Used in Anti-Ageing Trial

Pet Dogs to Be Used in Anti-Ageing Trial

Reuters - Innovations Video Online (Nov. 26, 2014) — Researchers in the United States are preparing to discover whether a drug commonly used in human organ transplants can extend the lifespan and health quality of pet dogs. Video provided by Reuters
Powered by NewsLook.com
Today's Prostheses Are More Capable Than Ever

Today's Prostheses Are More Capable Than Ever

Newsy (Nov. 26, 2014) — Advances in prosthetics are making replacement body parts stronger and more lifelike than they’ve ever been. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:

Strange & Offbeat Stories

 

Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins