Indiana Health Law Review, Vol. 9
96 Pages Posted: 19 Apr 2011 Last revised: 28 Jul 2013
Date Written: April 17, 2011
Both the safety of human subjects participating in medical research and the consumers of the research's products are of vital importance to the public's health. Unfortunately the current methods of over-seeing drug development and protecting whistleblowers makes it difficult for those involved in drug production or sales to bring forward information about hidden dangers. While some risks cannot be anticipated, others may be suppressed because they are against the manufacturer's financial interest.
Protecting the public is difficult because U.S. law divides human subjects' safety oversight into two separate jurisdictions: first, research funded by agencies of the Federal Government and second, drug trials paid for by pharmaceutical companies. This article addresses the latter. The Food and Drug Administration (FDA) controls every aspect of the development, production and marketing of a drug to be sold in the United States.
This article identifies the dangers to the public during drug testing and the marketing of a new drug, reviews the existing options for protecting those with knowledge, and proposes that the FDA adopt a new rule to encourage those with information to bring it to the FDA's attention. Extending and reforming protection for whistleblowers is a particularly effective intervention because it aligns with long-standing traditions, within science and medicine, for individuals to step forward and report wrong-doing.
It then proposes that the FDA initiate two methods of reform. First the FDA should establish a mechanism for obtaining and reviewing anonymous concerns about the safety of clinical trials or recently marketed drugs. Second, the FDA needs to require sponsors applying for Investigational New Drugs (IDA)s or New Drug Applications (NDA)s to develop real-time monitoring systems which will use interoperable electronic medical records and pharmacy records to track the health of both research subjects and consumers. Finally, Sponsors must certify that they have adopted broad and effective Whistleblower protection as an incentive for employees to come forward and provide information without concern that they will be retaliated against if discovered as its source.
Improving information flow by developing a safe and effective whistleblower procedure will not be an easy task. Drug trials are complex and often occur at multiple test sites, both public and private, in many different states in the United States, as well as overseas. As a result, the pool of potential people with relevant knowledge is very large and transcends employment status, job title or physical location.
Direct action by the FDA is necessary because traditional whistleblower protection statutes are usually quite specific and often will only protect disclosures directly related to violations of a specific statute.
Keywords: FDA, Whistleblower, clinical trial, international, human subject, research, Constitution, Pharma, drug, device, biologic, NIH, OHRP
Suggested Citation: Suggested Citation
Bard, Jennifer, What to Do When You Can't Hear the Whistleblowing: A Proposal to Protect the Public's Health by Providing Whistleblower Protection for Medical Researchers (April 17, 2011). Indiana Health Law Review, Vol. 9. Available at SSRN: https://ssrn.com/abstract=1813423