The featured article, by John F. Peppin, D.O., F.A.C.P., John J. Coleman, Ph.D., and Kenneth L. Kirsh, Ph.D., examines the history and suitability of the Food and Drug Administration's (FDA) Risk Evaluation and Mitigation Strategy (REMS) for reducing the safety risks associated with the use of opioid medications, including the risks of abuse and overdose. This article highlights recent attempts by the FDA to introduce a class wide REMS for new and existing Schedule II long-acting opioid drugs. A critique of these current REMS efforts and recommendations for the future are also provided.
The article includes a literature review and commentary designed to highlight issues surrounding REMS efforts and to explore possible future directions. Expert opinion is offered to potentially guide future efforts in this arena.
The authors conclude that the stated goal of the FDA's proposed class wide opioid REMS program is to decrease abuse, misuse, addiction and overdose deaths from opioid medications. While the REMS program may have theoretical capabilities for evaluating and addressing problematic drug use among prescribed patients, it is unlikely to reduce the bulk of prescription drug abuse that occurs with non-patients. The authors' recommendations provide some ideas on how the REMS program may be improved to achieve the goals set for it by Congress and the FDA, without limiting access to pain medications for patients who need them.
In the second article, law student Robert Coleman explores whether the health care reform legislation pending at the time of his writing, now known as the Patient Protection and Affordable Care Act of 2010, establishes an administrative body effectively charged with the rationing of health care resources, i.e., a presidentially appointed Independent Medicare Advisory Committee (IMAC) in section...