July 20, 2012

FDAGate — The Latest Lapse in Government Enforcement

By Gordon Schnell 

In what quickly has become the most recent “gate” scandal in Washington, the evidence continues to mount that the FDA acted to stifle whistleblowers within its own ranks.  It all began several years ago when a half-dozen FDA scientists and doctors objected to certain imaging devices for mammograms and colonoscopies because of the high levels of radiation they believed the equipment emitted.  The scientists and doctors were overruled by their supervisors and the FDA approved the sale of these medical devices. 

 Not happy with the FDA’s decision, the scientists and doctors complained to various lawmakers, journalists and even President Obama.  It was not just their distress over the FDA’s decision to approve these dangerous devises.  It was also about their broader concern that the FDA had become a “broken” agency no longer fit to fulfill its consumer protection mission.  This was a rather troubling observation coming from those inside the agency tasked with protecting public health and safety.

Rather than air and address these concerns openly, the FDA took a different approach — one of containment and damage control, harassment and abuse.  It began an extensive spying campaign on these disgruntled employees, monitoring and intercepting their personal emails, copying documents off of their thumb drives, and even following their messages line by line as they were being typed.  The software the FDA used to track these renegade scientists was apparently the same kind marketed to parents to keep tabs on their children’s computer activity. 

The agency also reached out repeatedly to the Inspector General’s Office of the Department of Health and Human Services requesting an investigation into the whistleblowers’ supposed disclosure of confidential business information.  The IG’s Office denied each of the FDA’s requests.  It also went out of its way to stress that the scientists and doctors did nothing wrong in publicly airing their public safety concerns.

The Office of Special Counsel, an independent agency that looks into government wrongdoing, is now investigating the FDA’s conduct in all of this.  So are a number of government officials, including Senator Charles Grassley (R-Iowa), Washington’s most ardent supporter of whistleblowers and their role in government oversight.  The Senator recently hammered the FDA for acting “more like the East German Stasi than a consumer protection agency in a free country.” 

As troubling as the FDA’s alleged spying activity is, what is even more disturbing is what it says about the state of government enforcement these days.  We’re talking about the agency that is supposed to be on the frontline of ensuring that our drugs and medical treatments are safe and effective.  But it will not even tolerate honest and open debate among the very medical specialists on whom it is supposed to rely.  Worse off, the agency has clearly evinced a deep-seated hostility towards whistleblowers.  Yet these are the people who are uncovering about 85 percent of healthcare fraud these days which on last count was topping $60 billion a year. 

The FDA fiasco seems to be just the latest symptom of a growing breakdown in government enforcement.  But this one goes well beyond the recent string of financial failures that have slipped through Washington’s grip.  Hopefully, it will serve as a wakeup call to the drug regulator and be a stark reminder that the agency is supposed to be about consumer protection above all else.  For when it comes to our health and safety, there should be no holes in our regulatory safety net.

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