Post-Market Drug Regulation in the Age of Big Data: What Path to the Promised Land?

FDLI's Food and Drug Policy Forum; 4(10), 1-14, 2014

14 Pages Posted: 29 Oct 2014  

Ryan Abbott

University of Surrey School of Law; University of California, Los Angeles - David Geffen School of Medicine

Date Written: October 29, 2014

Abstract

This article argues that an administrative bounty proceeding should be established to motivate third parties to submit data on drug safety and efficacy to the food and drug agency. The administrative bounty proceeding should be modeled after the Federal Claims Act qui tam regime, and the federal government should pay petitioner rewards based on a portion of the money that the government will save by avoiding adverse effects and medically ineffective therapies in patients with government health insurance.

Keywords: big data, post-market drug regulation, false claims act, food and drug agency, market incentives, health care financing

Suggested Citation

Abbott, Ryan, Post-Market Drug Regulation in the Age of Big Data: What Path to the Promised Land? (October 29, 2014). FDLI's Food and Drug Policy Forum; 4(10), 1-14, 2014. Available at SSRN: https://ssrn.com/abstract=2514601

Ryan Benjamin Abbott (Contact Author)

University of Surrey School of Law ( email )

Guildford
Guildford, Surrey GU2 5XH
United Kingdom

University of California, Los Angeles - David Geffen School of Medicine ( email )

1000 Veteran Avenue, Box 956939
Los Angeles, CA 90095-6939
United States

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