An FDA of One

  • by: |
  • 10/26/2007
By now you will have heard about the most recent in a series of FDA leaks. I refer specifically to the Wall Street Journal's "people with knowledge of the matter" -- the matter at hand being Avandia.

I will not speak to the specifics of the leak -- I will not give illegal and unethical behavior one inch of additional space -- nor will I spend any time or energy playing the "I wonder who the leaker is?"game. (Not that I don't have my own suspicions.)

What I do want to address is the growing trend within the FDA of "leaking" internal discussions to the media in order to try to force the agency's hand. If "politicizing" the agency is bad (and it is -- very much so) than it is bad writ large. The ends does not justify the means.

The FDA is an organization of health care professionals. An organization of many. Organizations have hierarchies. And organizations have rules. And rules are meant to be followed. The alternative is chaos -- a state into which the agency mustn't spin. When rogue employees choose to take the law into their own hands -- even when they believe their position is the correct one -- bad things ensue and stakeholder trust erodes. And, yes, one stakeholder is the pharmaceutical industry. Another is the American citizen.

Anonymous leaks are not the acts of whistleblowers -- they are the acts of cowards.

An "FDA of One" is one very bad idea.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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