On Tuesday, November 22, Merck announced that it had reached a half-billion-dollar agreement with numerous state governments and with the federal government to settle civil charges that the company had illegally promoted Vioxx for off-label uses and that it had misrepresented the drug's risks.

The question of “misrepresenting” the drug’s risk may be set aside for the moment. The main point of interest here is the matter of off-label uses, which I have written about before . This is clearly a matter of criminalizing behavior that ought to be legal.

But there are two ways of writing about the criminalization of behavior that ought to be legal. One can argue that current law violates certain norms (over-criminalization) or one can argue that a certain justifiable legal impulse has gone off the rails over the course of its history (creeping criminalization).

Here, taking the first approach, is an excellent article by Greg Conko of the Competitive Enterprise Institute. He argues that, in the matter of “off-label promotion,” current law violates certain constitutional norms—because it typically restricts legitimate commercial speech by company representatives addressing physicians, speech that informs the physicians of clinically proven, safe, and effective uses of pharmaceuticals. To me, Conko’s argument is utterly convincing.

But to many readers, I suspect, Conko’s argument may sound like legalistic casuistry on behalf of drug companies that are recklessly seeking profit. A more convincing argument, I believe, would begin with the state of fraud in nineteenth-century America, captured memorably by Herman Melville’s The Confidence Man and several of Mark Twain’s hilarious short stories (such as “The Canvasser’s Tale,” about a travelling salesman who sold echoes). It would then expose the FDA as the child of a fanatical, German-educated regulator who drew fraudulently (sweet irony) on legitimate and commonsense notions of fraud. And it would expose current FDA law as the Public Choice product of a power-seeking bureaucracy that has continually expanded the FDA’s mandate ever since its origins.
In that perspective, I believe, today’s pharmaceutical companies could more convincingly be presented as victims, rather than victimizers.


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