September 17, 2014

Summer Clearance: More FDA ‘Spygate,’ CAPA Warnings

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Spring is traditionally the time to clean house, but we thought there were at least two items to take a look at again with updates as Summer 2012 winds down: The FDA’s embarrassing ‘Spygate’ scandal where agency officials are alleged to have eavesdropped on their own scientists, and the agency’s continued focus on CAPA in warning letters.

Certainly ‘Spygate’ is the juicier topic, and of more interest to the public at large. As we and others have noted before, it is chilling if the agency even appears to be trying to intimidate its scientists and other experts. Galileo could tell us all about the downsides of that kind of interference.

But it looks like Spygate isn’t going away, and in fact may have been worse then first suspected.  A Forbes contributor, Jon Entine, suggests that the earlier media coverage may have missed the point.

Specifically criticizing coverage in The New York Times, Entine notes that its articles “generated national headlines with its sympathetic portrayal of harassed scientists risking their careers to protect the public interest.” But, Entine suggests, “new revelations suggest the Times slanted the story by leaving out critical context. It appears that dissident employees are involved in what could be seen as an ambulance chasing shakedown scheme to profit from their allegations. In December 2009, while these ‘aggrieved’ reviewers were publicly lobbying the FDA and Congress to crack down on scanning devices, they had secretly filed a whistleblower lawsuit against these very same manufacturers that if successful could make them multi-millionaires.

Yikes.

Entine’s verdict? “The case has exposed the underbelly of what some critics believe is one of the more dysfunctional regulatory agencies in the federal government.”

Sure, CAPA is a relatively tame topic after all that cloak and dagger talk, but day in and day out the agency’s laser-like focus on it is arguably more important to the basic operations of device and pharmaceutical manufacturers. And here’s more evidence that trend isn’t changing: A tough July 17 warning letter to Medtronic hitting the company for assorted CAPA-related problems.

“FDA requests a prompt meeting with you [Medtronic] to discuss the pump motor corrosion failure mode and the scope and timing of corrective actions to address this ongoing problem,” the warning letter advises.  In other words, the agency didn’t like the CAPA program it saw in place there.

That meeting is set for Friday, September 7, just after the Labor Day holiday and the traditional end of the bathing suit season.

I wonder if those Medtronic folks are looking forward to the end of summer.

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