WASHINGTON — The Food and Drug Administration put patients' lives at risk by halting enforcement of 30-year-old requirements that medical device makers meet federal laboratory standards prior to testing their products on humans, a watchdog group charges in a new report.
The rules at issue cover studies on an array of devices, including life-saving products such as defibrillators, pacemakers, coronary stents and heart valves.
The report by the nonprofit Project on Government Oversight is to be released Wednesday and says several agency officials left their jobs because they were so upset over the policy to forgo enforcement of requirements that the tests adhere to Good Laboratory Practices.
"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," the report says.
It calls the agency's decision to halt lab inspections on animal studies and other early research "stunning in its contempt for the protection of patients" and its failure to comply with federal regulations.
The report offers the latest harsh critique of the FDA's regulatory performance during the Bush administration. In 2007, a group of experts from industry, academia and the government warned that the agency was understaffed and overworked, raising "incalculable risks" to the public safety.
In a statement late Tuesday, Siobhan DeLancey, an FDA spokeswoman, said: "In recent years, we have not conducted as many inspections specific to GLP as we have in the past. 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."
In a letter to POGO in May, Casper Uldriks, the head of regulatory guidance for the FDA's Center for Medical Devices and Radiological Health, said the FDA's enforcement is adequate.
Uldriks noted that the agency requires manufacturers to submit documentation at three stages of the approval process vouching that their studies met the Good Laboratory Practice regulations. The FDA relies on those assurances and doesn't actually inspect those labs prior to any human studies.
POGO's report doesn't provide the precise timing of the decision by the FDA's medical device center to stop enforcement of the laboratory standards for non-clinical tests, but traced to at least early 2006.
On Aug. 31, 2006, Michael Marcarelli, director of the center's Division of Bioresearch Monitoring, sent an 11-page memo to Linda Kahan, the center's deputy director, documenting instances in which major manufacturers were found by agency inspectors to have failed to comply with testing standards.
Marcarelli, who began drafting the memo in January of that year, cited multiple agency legal opinions concluding that the 1978 Good Laboratory Practices carries the force of law.
Manufacturers' non-compliance, he wrote, is "a major problem in the medical device industry that is based upon the lack of communication with industry and FDA reviewers."
He recommended that the agency immediately resume inspections on labs testing the most critical medical devices.
However, the report said, Kahan called an emergency meeting soon after receiving the memo and said there would be no change in the center's enforcement policy.
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