The Project On Government Oversight released today its latest report, The FDA's Deadly Gamble with the Safety of Medical Devices, laying out a disturbing case against the officials in charge of a Center of the Food and Drug Administration--the Center for Devices and Radiological Health (CDRH)--responsible for overseeing the safety of medical devices.
POGO's report documents the shocking decision by senior CDRH officials to ignore the Good Laboratory Practice (GLP) regulation, a decision that may put patients' lives at risk. This regulation was issued in 1979 to protect patients from unsafe drugs and devices by no longer allowing manufacturers to set their own standards of laboratory testing. Under current practice, manufacturers and testing facilities are left to monitor their own compliance with the regulation.
"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 decision by top CDRH officials to not enforce GLP is stunning in its contempt for the protection of patients and its indifference to standards that comply with federal regulations. Their decision, which was made over the strong objections of CDRH scientists, is no harmless blunder. It is a high‑stakes, unknown‑odds gamble with the lives of patients--particularly those whose survival depends on life-sustaining medical devices such as cardiac defibrillators, pacemakers, replacement heart valves, and coronary artery stents.
The FDA's mission--to protect the public health--depends on vigorous oversight and enforcement as a matter of agency policy. When the FDA fails to enforce certain regulations, the consequences can be lethal.
A summary of the report's recommendations:
- The GAO or the HHS IG should audit records that contain evidence of device manufacturers' compliance or noncompliance with the GLP regulation.
- Congress or HHS IG should conduct an investigation of the decision made by senior CDRH officials to ignore or deemphasize enforcement of the GLP regulation.
- After auditing has established 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.