FDA Has Reduced Enforcement of Standards for Medical Device Laboratories, Report Finds

The Center for Devices and Radiological Health at FDA in recent years has reduced enforcement of "good laboratory practices" for facilities that develop medical devices, according to a report released on Wednesday by the Project on Government Oversight, the AP/Kansas City Star reports. According to the report, CDRH has decreased inspections of labs that conduct clinical trials of medical devices on specialized machines or animals to ensure that the facilities comply with the standards.

CDRH in 2008 conducted only one such inspection, compared with seven in 2007 and 33 in 2005, the report found. In addition, CDRH has scheduled no inspections for 2009, according to the report (Alonso-Zaldivar, AP/Kansas City Star, 2/18). The report also found that several FDA officials have left the agency because of the reduction in enforcement of the standards (Gordon, McClatchy/Kansas City Star, 2/18).

The report did not determine whether the reduction in enforcement of the standards resulted in injuries to patients (AP/Kansas City Star, 2/18). The report also does not indicate when CDRH decided to reduce enforcement of the standards, but traced the practice to as early as 2006 (McClatchy/Kansas City Star, 2/18).

The report states, "The decision ... to not enforce (lab standards) is stunning in its contempt for the protection of patients" (AP/Kansas City Star, 2/18). In addition, the report states, "At present, if a manufacturer knowingly violates the GLP regulation and falsely asserts compliance with GLP, that manufacturer is safe -- safe from discovery, safe from disciplinary action by the FDA, safe from prosecution" (McClatchy/Kansas City Star, 2/18).

Ned Feder, a staff scientist with POGO, said, "A decision of this magnitude by top officials should have been made openly, perhaps on the FDA's Web site, where it could be seen and criticized," not "made behind closed doors" (AP/Kansas City Star, 2/18).

In a statement, Siobhan DeLancey, an FDA spokesperson, said, "In recent years, we have not conducted as many inspections specific to GLP as we have in the past," adding, "We continue to review our inspectional plans, and (the agency) maintains the authority to request additional information on GLP adherence from a manufacturer and inspect any facility for GLP compliance" (McClatchy/Kansas City Star, 2/18).

The report is available online.