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:1/24/2017)... ... January 24, 2017 , ... OMI Industries, ... officially formed a distribution partnership with Byers Scientific & Manufacturing , a ... , Through the agreement, OMI Industries formulated a special version of Ecosorb® for ...
(Date:1/24/2017)... ... January 24, 2017 , ... Center for Hispanic Leadership (CHL) ... named Hector M. Chavez, Manager, Employee & Labor Relations at City of Hope ... Hispanic Leader of the Month. City of Hope is committed to stay out in ...
(Date:1/24/2017)... ... January 24, 2017 , ... The University of Iowa, ... great care to design a program that provides teachers with the specific skills and ... online teaching certificate is ideal for post-baccalaureate students and HigherEducation.com is working to ensure ...
(Date:1/24/2017)... ... January 24, 2017 , ... The NewKILO JRP, a three-year project of the ... the European Union (EU), was completed in May 2015. The future definition will require ... used in air, which presents some challenges to establishing traceability to the mass scale. ...
(Date:1/24/2017)... ... January 24, 2017 , ... Today, Taza Agua, Costa ... bottles, designed specifically to optimize the drinking experience for K-Cup coffee, tea and ... introducing the world’s first untouched bottled water purposed exclusively for creating a superior ...
Breaking Medicine News(10 mins):
(Date:1/24/2017)... GERMANTOWN, Md. , and GAITHERSBURG, Md. ... XON ), a leader in the engineering and ... health of the planet, today announced that it has entered ... (NASDAQ: GNVC ), a clinical-stage company and pioneer ... Intrexon intends to integrate and expand upon GenVec,s expertise ...
(Date:1/24/2017)... , January 24, 2017 www.Financialbuzz.com ... growing industries in the United States ... in 2016. In addition, Proposition 64, the California Cannabis Legalization ... 42.87% against on November 8, 2016. This outcome means that ... use and to grow a certain amount of cannabis for ...
(Date:1/24/2017)...   QR Pharma , Inc., a privately ... for the treatment of Alzheimer,s, Parkinson,s and other ... world-class key opinion leaders to its Scientific Advisory ... previous roster of impressive advisors in order to ... development of the breakthrough mechanism of action of ...
Breaking Medicine Technology: