July 15,2005

Chairman Grassley comments on Institute of Medicine report on safety of medical devices for children


TO: Reporters and Editors
FR: Jill Kozeny, 202/224-1308
RE: Institute of Medicine Report - “Safe Medical Devices for Children”
DA: Friday, July 15, 2005

Sen. Chuck Grassley, Chairman of the Committee on Finance, issued the followingcomment about a report to be released on Monday, July 18, at 4 p.m. by the Institute of Medicine.

Sen. Grassley’s comment is embargoed until the release of the IOM report. The reportassesses postmarket surveillance and safeguards on medical devices used for pediatric care. Sen.Grassley has conducted oversight of the Food and Drug Administration over the last 18 monthsand called for administrative and legislative changes to make the agency more responsive to newinformation about safety risks with drugs and devices.

“This report exposes a fissure in the FDA’s safety mission when it comes to surveillanceof medical devices for children. It documents how the FDA is neither properly monitoringpostmarket studies nor making important postmarket research publicly available. These are thesame kinds of problems we’ve seen with postmarket review of medicines. The Institute ofMedicine spells out remedies that should be pursued to better protect children who rely on FDAapprovedmedical devices, and I intend to work to help improve the situation.”