Scott Gottlieb had this editorial in yesterday's Wall Street Journal discussing the Justice Department's recent criminal prosecutions of pharmaceutical companies for marketing prescription drugs to physicians for "off label" uses. Ted Frank gives his views as well Ed Silverman. Both make good points and there's much to dislike about the heavy handed use of criminal sanctions to enforce corporate behavior in these cases. Yet, Gottlieb's essay falls short.

There is no question that off label uses of pharmaceutical drugs is both endemic and necessary. Moreover, as Daniel Carlat has emphatically suggested finding physician education not sponsored by the pharmaceutical industry is almost impossible; physicians rightly or wrongly rely on drug companies to inform them about the latest developments in pharmaceuticals. But when drug company representatives enter the realm of advising doctors on non-FDA approved uses they are indeed entering treacherous territory. Drug representatives, on the whole, have no medical training and are merely passing along company script when advising physicians about medications. This may be fine when we're talking about FDA approved uses; after all these uses were subjected to rigorous formal trials, peer review, and extensive overview by the FDA. Off label uses are exactly that: not used in conjunction with the science that supports their official use, and hence, almost devoid of the review that gives us assurances that the medicines are safe and effective. As such, the FDA concern about this practice is justified albeit the criminal path may be the wrong method to correct it by.