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Industry keeping an eye on drug risk-management model

This article was originally published in The Silver Sheet

Executive Summary

CDRH may be moving toward imposing more risk-management measures on moderate-risk devices, on the model of recent statutory risk-management authorities for drugs, industry lawyers say. On the drug and biologics side, Title IX of the FDA Amendments Act of 2007 authorizes FDA to require sponsors to submit a Risk Evaluation and Mitigation Strategy (REMS) to manage a known or potential serious risk. This has raised questions as to whether CDRH also may seek expanded risk-management authority, lawyers from the Washington, D.C., firm Sidley Austin said during a Nov. 13 teleconference hosted by the firm and F-D-C Reports/Windhover Information. The attorneys say that CDRH has steadily been exercising "REMS-like" powers over more devices. They point to CDRH public health notifications warning of risks associated with specific devices and recommending special physician training. However, Susan Gardner, director of FDA's Office of Surveillance and Biometrics (OSB), was circumspect on whether the device center will gravitate toward the REMS model. "As part of our post-market transformation, we continue to address improvements in our ability to assess product risk both pre- and post-market," she says
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