Whistleblower Protections for FDA and Private-Sector Employees

Abstract

The goal of this paper is to provide an introduction to the whistleblower protection laws that impact the FDA as well as publicly traded pharmaceutical companies. The paper begins by discussing the recent developments surrounding Merck’s voluntary recall of Vioxx. The discussion focuses on the fact that Merck allegedly knew of the drugs safety issues yet kept it on the market for several years, even seeking additional indications from the FDA. The paper looks at David Graham’s involvement as a whistleblower and examines his best avenue for redress against retaliation, the Whistleblower Protection Act of 1989. Following the discussion of the Whistleblower Protection Act, the paper considers what the options would have been were a whistleblower to come from within a pharmaceutical company instead of from the FDA. That discussion revolves around the Sarbanes-Oxley Act. I outline how and why Sarbanes-Oxley applies to pharmaceutical companies and then move to an analysis of the Act’s statutory language, outlining how one would bring a Sarbanes-Oxley whistleblower claim procedurally. Following this discussion, the paper gives a cursory analysis of other whistleblower retaliation statutes and issues, attempting to alert the reader that there are other avenues available and that additional considerations may be necessary, depending on the particular circumstances surrounding the retaliatory action. The paper concludes by looking at the current whistleblower climate and suggesting that the FDA may need its own whistleblower statute, particularly if courts begin to reign in Sarbanes-Oxley’s currently widening scope.