November 29, 2012

Another Bad Report Card for the Beleaguered FDA

By Gordon Schnell

The Food and Drug Administration (FDA) admittedly has a lot on its plate.  Tasked with regulating the country’s food and medicine supply, not to mention the ever-evolving array of medical devices and procedures, the FDA is the federal agency perhaps most responsible for ensuring our health and well-being.  If the agency does not perform up to task, a lot of people are affected.  So it is no wonder that over the years, the agency has faced some serious questioning, even within its own ranks, as to whether it is always acting as the vigilant watchdog it is supposed to be. 

It was only a few months ago that the FDA was rocked with allegations that it spied on and retaliated against several of its own scientists and doctors who reported to lawmakers their disagreement with the FDA’s approval of certain medical imaging devices.  The concern was not simply over the FDA’s decision to approve what these doctors saw as dangerous devices.  It was also about their concern that the FDA had become a “broken” agency no longer fit to fulfill its consumer protection mission.  See FDAGate — The Latest Lapse In Government Enforcement

This broader concern about the FDA’s capability and competence is a recurring theme these days with all of the fraud that is occurring in the pharmaceutical and medical device community.  It seems as if every month or so the Department of Justice is entering into nine and ten-figure settlements with one major company or another for engaging in a host of fraudulent endeavors to beef up their bottom lines.  See What Is Going On With Big Pharma?  The chronic misadventures of these industry players, all on the FDA’s watch, certainly begs the question as to whether the FDA is doing all it can to rein in this recidivist activity and be the strong regulator on which we all depend.

According to a report released last week by the Partnership for Public Service and funded by the Pew Charitable Trusts, the FDA has a long way to go.  This report was a follow-up to a November 2007 study by the FDA Science Board which the FDA commissioned to assess how well the agency was doing its job.  The results of that study were pretty dismal, finding that the agency lacked sufficient scientific expertise and was not positioned to meet its current or emerging regulatory responsibilities.  Click here to see the study. 

The new report shows that the FDA has made some progress since the 2007 findings.  The agency’s budget and workforce have increased significantly.  And the agency has taken steps to improve their staff training and development.  But apparently the agency is still suffering from some serious workforce failures — the FDA’s hiring process still takes too long and does not necessarily attract the highest quality candidates; the FDA is still not doing enough to train new employees; and the agency is still failing to foment an environment of career growth and opportunity. 

The bottom line conclusion from the report is that all of these failings are continuing to inhibit the FDA from fulfilling “its public health obligations to the American public and its responsibilities to the industries it regulates.”  It then lays out a series of recommendations to help the agency sure up these deficiencies and get the agency closer to where it needs to be to properly carry out its mission.  It appears that the agency has already begun to take steps to incorporate some of these suggestions.

Whether all of the negative attention the FDA suffers through is fair remains an open question.  Ironically, as the report points out, it is this very kind of negative imaging which reinforces the problems the agency faces in attracting and keeping the very best talent.  But what is clearly not in dispute is the critical need to get the agency to a point where it has the money, talent, resources and drive to do everything that needs to be done to ensure that the food we eat, the drugs we take, and the medical tools and procedures we use are as safe and effective as they are supposed to be.

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