This report by the Project On Government Oversight lays out a case against the officials in charge of a Center of the Food and Drug Administration—the Center for Devices and Radiological Health (CDRH)—charged with overseeing the safety of medical devices. A crucial internal document of August 2006 obtained by POGO reveals a decision made by senior CDRH officials that puts patients' lives at risk. These officials decided, without public notice, to ignore the long-standing Good Laboratory Practice (GLP) regulation.
The GLP regulation sets specific requirements for the testing of medical devices, including life‑sustaining devices such as cardiac defibrillators, pacemakers, replacement heart valves, and coronary artery stents. The requirements for GLP testing are supposed to be met before CDRH deems these devices safe enough to be implanted in humans for the first time. But with CDRH ignoring the enforcement of the regulation, manufacturers and testing facilities are now trusted to monitor their own GLP compliance.
CDRH's decision to not enforce the GLP regulation has weighed heavily on Center scientists, many of whom believe that enforcement is required not only on regulatory but also on ethical grounds. In 2006, the head of CDRH's Division of Bioresearch Monitoring confronted Center management about the lack of enforcement. The response was swift and decisive—there would be no return to the previous policy of enforcement. That CDRH would not be enforcing the GLP regulation was reiterated by a Center employee at a meeting of the Society of Quality Assurance, a position that astonished those in attendance.
The decision by top CDRH officials to not enforce the GLP regulation 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. It was also made without public notice.
The deliberate disregard of the GLP regulation can be understood better when viewed as one of a range of serious problems in the FDA as a whole. The FDA's troubles start with its budget, which has not kept up with its growing responsibilities. For years, the agency has been underfunded, understaffed, and overworked. The gross inadequacy of the FDA's budget has resulted in an agency that "can no longer fulfill its mission without substantial and sustained additional appropriations."1 Some critics of the FDA say that manufacturers' requests for evaluation of drugs and devices are processed by the FDA too hastily and with a bias toward approval. They see the FDA leadership as frequently bowing to political influence and to the wishes of the industry it regulates, leading the agency to exert improper pressure on FDA scientists during their process of evaluating the safety of medical devices.
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.
Summary of Recommendations
- 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 without prior public announcement.
- The GAO or the HHS IG should audit those records related to GLP which may contain evidence of device manufacturers' compliance or noncompliance with the GLP regulation.
- After auditing has established the facts, CDRH should implement a program of GLP enforcement.
- If serious violations of the GLP regulation are found, either during the audit recommended here or after resumption of enforcement actions by CDRH, the range of possible responses should extend beyond the usual Warning Letter and should include referral for possible criminal prosecution if circumstances warrant it.
- The possible role of GLP noncompliance should be considered whenever a device malfunctions either during clinical testing or after marketing.
- Senior FDA officials should require full transparency in all agency actions other than those whose public disclosure is 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.
- Congress and the administration should at least double the budget of the FDA by 2012.