Medical Affairs Focus

Thoughts on Global Medical Affairs

OffTopic: The FDA Monitoring and Whistleblowing Scandal

Have you been following this issue?  It gets more and more fascinating the further you dive into it.  A excellent and definitive analysis can be found here, but for those of you too busy to read six small print pages, allow me to summarize:

The Setting:

Late in the 2nd Bush Admin, at the Center for Devices and Radiological Health (CDRH)

The Baseline Concern:

Some first-line reviewers felt that computer-aided cancer screening diagnostics should not have been approved for use based on their interpretation of the risks associated with by-product radiation and their lack of confidence in the data within the application

The Baseline Grievance:

 The first-line reviews saw their recommendations overturned by their senior management, who granted approval.

The Work to Resolve the Grievance:

 The first-line reviews complained to Office of Special Counsel (OSC), OIG,  members of Congress and eventually to the New York Times about the situation.

OK, already a nightmare but at least fairly clear.  Government employees are permitted under the law to ignore certain confidentiality requirements if the safety of the public is at risk.  They are not, however, allowed to disclose non-safety related confidential information publically.  This is where the first line may have been crossed.

The NY Times Gets Involved:

The NY Times publishes an article describing the situation and including certain confidential information contained in the application and that may not have been directly related to safety concerns.

The Companies React:

The companies whose confidential information is now plastered over the front page of the NY Times demands that this stop.

 FDA Senior Management Reacts:

FDA senior management arranges to have the FDA-issued computers of a number of potential leakers secretly monitored – every website visit, every key stroke, every file downloaded.

Quick aside: to be fair to the FDA, every time an employee logs onto their FDA computer they are forced to read the following “You have no reasonable expectation of privacy regarding any communications or data transiting or stored on this information system….”  Seems to me its hard to argue that they did not have fair warning.

FDA Senior Management Finds the Leakers/Whistleblowers:

Some of those first-line responders are clearly found to be communicating with the NY Times and other media outlets.  They also find correspondence with Congress, OSC and OIG.

FDA Senior Management Terminates the Leakers/Whistleblowers:

Over the next couple of years the contracts of the leakers were not renewed.

Leakers/Whistleblowers Sue FDA for Wrongful Termination:

A lawsuit is, of course, already pending on this.

So far this is a really sad situation, but at least understandable.  Now, however, its all about to blow up.

FDA Contractor Screws Up Big Time:

An FDA document management vendor makes a world-class screw up – posting thousand of pages of information that was secretly captured from the computer monitoring on an unsecured website.  A terminated leaker/whistleblower discovers this accidentally while Googling her own name.

Everyone Blows a Gasket:

With the documents revealed, all sorts of groups blow a gasket.  The leakers/whistleblowers claim their rights were infringed.  Congress is furious because some of the communication that was monitored included communication to Congress.  The OSC and the OIG are very upset because some of the communication was to them.  Neither Congress nor OSC/OIG communications are supposed to be monitored.

And this is where we are today.

Frankly, this whole situation is a major fiasco.  It makes the FDA look like the most dysfunctional organization in the government, and that is saying something.  Clearly CDRH needs to be stripped down to the floorboards and rebuilt with a functional culture.

Why am I taking a “blame everyone” perspective instead of supporting the leakers/whistleblowers.  Normally that would be where my heart was at, but it was just released that those same leakers/whistleblowers had filed a secret lawsuit in court against the manufacturers whose products they felt were unsafe.  And this lawsuit was filed while those leakers/whistleblowers were still employed by the FDA reviewing exactly these products.  And those same leakers/whistleblowers demanded at least 15% of what would be a multi-billion dollar settlement.  Not what you would consider an impartial set of reviewers.

So, this is a pox on both houses situation.  We deserve and should expect better from the FDA.

What do you think?  Anything I missed?  Leave your comments below.

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