Report: FDA Dropped Early Medical Device Lab Inspections

A report released by nonprofit group The Project on Government Oversight (POGO) has found that the Centers for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has failed to carry out lab inspections of medical devices at the earliest stages.

The inspections in question by the Washington, D.C.-based nonprofit organization that investigates corruption are those in a category that includes internal devices such as stents, external devices such as breast pumps and diagnostic devices, such as thermometers and magnetic imaging machines.

“The FDA’s Deadly Gamble with the Safety of Medical Devices” states the result of not following Good Laboratory Practice (GLP) is putting patients’ lives at risk.

“There are many insiders who are deeply concerned that real harm is being done.Such a decision affecting public health should not have been made behind closed doors,” said Danielle Brian, executive director of POGO.

The report recommends:

• The U.S. Government Accountability Office or the Department of Health and Human Services’ (HHS) inspector general should audit records that contain evidence of device manufacturers’ compliance or noncompliance with the GLP regulation.

• Congress or the HHS inspector general should conduct an investigation of the decision made by senior CDRH officials to ignore or de-emphasize enforcement of the GLP regulation.

• After auditing and establishing the facts, CDRH should implement a program of GLP enforcement.

• The possible role of GLP noncompliance should be considered whenever a marketed device malfunctions, and these findings should be publicized by the FDA.

• Congress and the administration should at least double the budget of the FDA by 2012.

• Senior FDA officials should require full transparency in all agency actions other than those prohibited by regulation or law.

• Congress should pass legislation, and the president should issue an executive order to strengthen federal employee whistleblower protections.

• Congress should pass legislation that would make lawsuits by injured patients possible.

• The FDA’s policy for reviewing 510(k) devices should be reformed, with the goal of eliminating the 510(k) mechanism for all Class III devices.

Officials at the FDA did not immediately return phone calls for comment.

To view the complete report, visit www.pogo.org/pogo-files/reports/public-health/safety-of-medical-devices/ph-fda-20090218.html.