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

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