"Should the FDA evaluate and oversee the truthfulness and veracity of drug product claims or should this be left to decisions by the courts and/or self-regulation by manufacturers? This question now extends to EHRs..."

In Reply—Electronic Health Records and Drugs Prescribed for Off-label Indications

Tim K. Mackey, MAS, PhD

University of California, San Diego, CA

Bryan A. Liang, MD, JD, PhD

Global Health Policy Institute, San Diego, CA

"Importantly, the problem identified by Dr Porter is emblematic of a larger battle in our medical legal and regulatory environment. As detailed in our June commentary in this journal on the court decision Amarin v FDA1 and as discussed in subsequent commentaries in journals such as the New England Journal of Medicine2 and JAMA Internal Medicine,3 recent court decisions have consistently eroded the FDA's regulatory authority over off-label promotion activities. This is happening despite hundreds of millions of dollars in off-label fraud and abuse settlements successfully prosecuted by the US Department of Justice, many of which involved egregious off-label marketing that has directly endangered patients (such as promoting a drug for an indication or patient population with a “black box” warning).4

At the heart of this debate is a simple question: Should the FDA evaluate and oversee the truthfulness and veracity of drug product claims or should this be left to decisions by the courts and/or self-regulation by manufacturers? This question now extends to EHRs, with court decisions like Amarin stripping away the FDA's ability to vigorously regulate how commercial entities like EHR data vendors market and disseminate off-label information. It also raises a more fundamental issue: should commercial free speech be constitutionally protected, even when it potentially endangers public health?

Collectively, we argue that leaving important scientific and clinical decisions about off-label promotion in the hands of commercially driven entities endangers the checks and balances of the FDA's drug approval processes that emphasize safety and efficacy. It also compromises the important role of clinicians as the learned intermediary because the easing of off-label regulation, the retreat of FDA oversight, and more selective US Department of Justice enforcement will likely lead to the proliferation of poor-quality off-label information that clinicians will have to navigate and interpret."