FDA ROLE IN DESIGN OF COST-EFFECTIVENESS STUDY PROTOCOLS
This article was originally published in The Gray Sheet
Executive Summary
FDA ROLE IN DESIGN OF COST-EFFECTIVENESS STUDY PROTOCOLS is possible, Susan Alpert, director of FDA's Office of Device Evaluation, said Nov. 15 at a Blue Cross/Blue Shield conference on technology assessment in Arlington, Virginia. Noting that it has been "rumored that there might be a role for either FDA or another agency within [the Public Health Service] to look at cost effectiveness" of devices and drugs, Alpert said, "we would see a role for ourselves in designing" cost-effectiveness protocols "because clinical protocols and the evaluations of the products ...are in fact within our purview."