Aaron Kesselheim, MD, JD, MPH, of the Division of Pharmacoepidemiology & Pharmacoeconomics at Brigham and Women’s Hospital discusses the effects on medical innovation of statutes that provide additional intellectual property rights or related incentives to pharmaceutical, medical device, and biotechnology developers in the U.S.
Kesselheim considers the effects on medical innovation of statutes that provide additional intellectual property rights or related incentives to pharmaceutical, medical device, and biotechnology developers in the U.S. These laws include the Orphan Drug Act, the pediatric exclusivity provisions of the FDA Modernization Act of 1997, the Priority Review Voucher provisions of the Food and Drug Administration Revitalization Act of 2007, the Bayh-Dole Act (and subsequent amendments), and the Hatch-Waxman Act. He examines the evidence of how the implementation of these provisions has affected the quantity and quality of pharmaceutical, device, and biotechnology innovation, as well as any evidence about their effects on health outcomes. He sets an agenda for future public health law research in this important are of health regulation.
Kesselheim published a commentary about this topic, Using Market Exclusivity to Promote Pharmaceutical Innovation, in the New England Journal of Medicine (Nov. 4, 2010.). He also published an article in 2011 in The Milbank Quarterly, An Empirical Review of Major Legislation Affecting Drug Development: Past Experiences, Effects, and Unintended Consequences.