Friction between the First Amendment and the FDA’s attempts to regulate off-label drug promotion has existed for decades. It has sparked an ever growing body of case law that often finds the FDA overreaching. One of the more recent examples is the Second Circuit’s decision in Caronia, which vacated a criminal conviction that had been based on the FDA’s application of the Food Drug & Cosmetic Act’s misbranding provisions to off-label promotion. In the decision, the court declined “the government’s invitation to construe the FDCA’s misbranding provisions to criminalize the simple promotion of a drug’s off label use by pharmaceutical manufacturers and their representatives.” We’ve devoted a good number of our cyberpages to Caronia (here, here, hereand no doubt elsewhere) and to First Amendment issues in general (here is a link to a number of posts), ultimately concluding that truthful, non-misleading commercial speech on scientific issues, whether by drug manufacturers or other participants in the scientific community, should not be curtailed.
But that notion needs practical application, a comprehensive regulatory model that sits well with both the Constitution and the FDA’s regulatory mandate. That’s difficult to accomplish. The authors of a recent Journal of Law and the Biosciences article, “Back to first principles: a new model for the regulation of drug promotion,” however, have taken up the task. They have proposed a new regulatory model based on the reality that drug manufacturers engage in different types of communications, not solely commercial speech directed at the sale of drugs. Some communications involve the free exchange of scientific communication amongst professionals and associations within the scientific community, some do in fact involve the sale of a drugs (e.g., approved labeling, sales aids and product websites), and some fall in between. The authors propose different levels of FDA regulation for each type of communication, and at times no regulation at all.
We won’t go any further in describing it. We’ll only muck it up. Suffice it to say that it is a practical and through-provoking proposal. We recommend that you read the article. Here’s a link. Enjoy.