Andrew English, David Rosenberg & Huaou Yan, A New Regulatory Function for E-Prescriptions: Linking the FDA to Physicians and Patient Records (Harv. L. Sch. Pub. L. & Legal Theory Res. Paper Series, Working Paper No. 13-44, June 19, 2013).
Abstract: Despite recent improvements in FDA regulation of medical product usage, the Agency still lacks the capacity for directly and immediately sending physicians updated warnings and other advisories and for continuously overseeing their treatment decisions and outcomes. We propose deploying electronic prescription technology to fill this major regulatory gap. Although this technology has received extensive expert and funding support for its ability to better perform the time-honored functions of paper prescriptions, we are the first to consider its use to further FDA regulatory objectives. We make the case that by interfacing the FDA with physicians and computerized patient records, e-prescriptions can greatly improve the Agency’s capacity to inform, guide, and monitor medical product usage. Designed to operate in a check-off format, e-prescriptions would not only provide physicians with salient risk and efficacy alerts, best-practice protocols, and links to studies, but also query and specifically document their reasons for choosing off-label or contraindicated uses. In addition, by automatically requesting reports from physicians and retrieving information from computerized patient records, e-prescription technology can supply the FDA with comprehensive, systematic, and real time data on medical product outcomes, favorable as well as unfavorable. We assess these benefits against the costs of our proposal, including the extent to which a well-designed system would burden physician decisionmaking and expose patients to unnecessary and abusive surveillance of their medical records and treatments.