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
Date Written: October 29, 2014
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: Suggested Citation