Watchdog: Bush FDA decision put patients in danger

[babylonsister]

Watchdog: Bush FDA decision put patients in danger

By Greg Gordon | McClatchy Newspapers


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.

more...

http://www.mcclatchydc.com/251/story/62375.html

[hlthe2b]

1. Yet, Cheney managed never to get one of these defective devices....

Sometimes it seems there is no justice in the world.

[Why Syzygy]

2. kick