Physicians are legally free to use drugs approved by the FDA for one purpose for another purpose in the treatment of patients. In fact,some “off label” uses of FDA approved drugs represent the “standard of care” in the treatment of certain conditions.
On the other hand, pharmaceutical companies are banned under Sec. 331(a) and (k) of the Food, Drug and Cosmetic Act (“FDCA”) from advertising or otherwise promoting an off label use of a Drug approved under the FDA’s New Drug Approval process. In the case of United States v. Alfred Calonia, 576 F. Supp. 2d 385 (EDNY, 2008) Judge Vitaliano denied Mr. Calonia’s First Amendment motion to dismiss a criminal action against him for promoting the off label use of Xyrem, even though the judge determined that the off label use of the drug was not illegal and the representations of Mr. Calonia were neither false nor misleading. Now following Mr. Calonia’s conviction, the Pharmaceutical industry is mounting a full scale charge on the FDA ban, pushing for the Supreme Court to take the case to determine the constitutionality of those provisions of the FDCA.
The Current constellation of the Supreme Court has been vigorous in its application of the First Amendment to business and election financing issues and it appears that the Calonia case is ripe for a review. A direct concern is Judge Vitaliano’s application of the Supreme Court’s Commercial Speech guidance in Central Hudson Gas v. Public Service Commission of New York, 447 U.S. 557 (1980). Commercial speech, under established precedents, is of a lesser vitality than other speech and under certain circumstances can be constrained when faced with a greater competing government interest that is narrowly drawn. Here the issue is whether the speech promotes unlawful activity or its content is misleading (it does and is not);whether the government has an interest in protecting the public (it does); whether the restriction advances the government interest (it does); and finally, whether the restriction is closely tailored to use less intrusive means to accomplish the ends (???????).
The Supreme Court in Central Hudson, reminded us to be “specially skeptical of regulations that seek to keep people in the dark for their own good.” Congress and the FDA may have to go back to the drawing board on this one.