House report criticizes FDA device procedures

The Food and Drug Administration's medical device approval processwas taken to task this month in a report presented to a congressionalsubcommittee.

The report portrayed the FDA's Center for Devices and RadiologicalHealth (CDRH) as plagued by inefficient use of resources and apervasive bias in favor of device manufacturers.

The report quotes FDA device reviewers as stating that:

• an unofficial 2% limit exists on the number of devicedisapprovals allowed by managers of the CDRH's Office of DeviceEvaluation (ODE);

• device reviewers who disapprove applications havebeen harassed by superiors;

• reviewers spend considerable time and energy helpingdevice manufacturers get through the approval process, an activitythe report characterized as "consulting";

• documentation has been removed from files or destroyed;and

• management of the CDRH is disorganized and confused.

The report was presented to the House of Representatives subcommitteeon oversight and investigations by subcommittee investigator ThomasDorney, who sent confidential questionnaires to FDA device reviewers.

Although many questionnaires are still outstanding, about halfof those that have been returned claim that politics sometimescarries as much weight as science in the device approval process.

"A reviewer who completed the questionnaire (pointed out)the title of the Office of Device Evaluation should be changedto Office of Device Approval," Dorney said.

The chaotic approval process has the effect of penalizing firmswith well-made devices while benefiting companies that aren'tas well prepared or as competent, Dorney said.

FDA representatives at the subcommittee hearing responded byacknowledging that problems exist within the device approval process,but claimed the agency is moving quickly to remedy them. The FDAhas appointed a new ODE director with a strong scientific background,has launched a series of internal audits of the approval processand has appointed an integrity officer.

Reform of the agency's approval process is needed, said subcommitteechairman John Dingell (D-MI). However, any such reform must bedone without "bringing the approval process to a grindinghalt," he said.