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Using Patent Data to Assess the Value of Pharmaceutical Innovation

Published online by Cambridge University Press:  01 January 2021

Aaron S. Kesselheim  and
Jerry Avorn
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Extract

Only 19 new molecular entities and 3 biologics were approved by the Food and Drug Administration (FDA) in 2007, the lowest rate in 24 years. This disappointing output occurred despite steady clinical trial and regulatory review times, the FDA maintaining high approval rates, and the pharmaceutical industry consistently reporting increasing revenues. A government report suggests that fewer new drug applications have been submitted to the FDA by the pharmaceutical industry in recent years. These data have rekindled the debate as to the origins of pharmaceutical innovation and the comparative importance of public and private sources in contributing to drug discovery. The pharmaceutical industry contends that its research is responsible for most new medicines, and that the primary public institution supporting U.S. biomedical research, the National Institutes of Health (NIH), supports medical innovation “distinct from the process of drug development.”

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 37 , Issue 2 , Summer 2009 , pp. 176 - 183
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

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