What Standards Will Apply To Federal Drug 'Unsales' Force?

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Proponents of health care “reform” have invested an enormous amount of time and effort proclaiming how pharmaceutical company sales representatives (colloquially known as “detailers”) and their visits to medical professionals increase the cost of patient treatments and, in turn, health care in general.  For this reason, state and federal regulators have piled on laws and rules dictating what these detailers can and cannot say and do to educate physicians about their products.  Some states, most prominently Pennsylvania, have programs where purportedly independent clinicians, pharmacists, and others pay visits to doctors to essentially counter what they hear from drug detailers.

This counter-detailing, or academic detailing, is now poised to move forward at the federal level as a way to circulate government-manufactured “comparative effectiveness” research funded by the 2010 Recovery Act and advanced in ObamaCare.  The aim of comparative effectiveness is to reduce health care costs, an especially compelling goal for our government, the number one purchaser of medical treatments in America.  This fact begs the question: can academic detailers, paid by federal taxpayers and distributing federally-funded research be considered unbiased or neutral?  And, if that is the case, what safeguards exist to ensure that this federal “unsales” force isn’t sacrificing the highest quality patient care in favor of saving money?

In fact, at this point, no such safeguards exist.  Peter Pitts, a former FDA Associate Commissioner who is currently President of the Center for Medicine in the Public Interest, explores this question and puts forward many more important queries in a Washington Examiner op-ed, “What a Difference Two Words Can Make in Health Care.”  Those questions include:

·  “Will these studies be peer-reviewed before release?”


·  “If academic detailers stray into off-label conversations, to whom does Food and Drug Administration send a letter?”

· “Who will determine the difference between “communicating” these findings and “promoting” them?”

These are all issues worthy of consideration by those who oversee federal implementation of the health care reform law.

Cross posted at Washington Legal Foundation's The Legal Pulse.


Cory L. Andrews is Vice President of Litigation for Washington Legal Foundation. Before joining WLF, Mr. Andrews was an appellate attorney at the law firm of White &...