Pharmaceutical Law
Perhaps one of the greatest ethical challenges of pharmaceutical marketing will be a result of overreach of the Justice Department with respect to its interpretation of the First Amendment. Indeed, in his dissenting opinion in Sorrell v. IMS Health, Inc., Justice Breyer argued, "If the Court means to create constitutional barriers to regulatory rules that might affect the content of a commercial message, it has embarked upon an unprecedented task -- a task that threatens significant judicial interference with widely accepted regulatory activity" (Berman, 2011, p. 36). A pharmaceutical manager would do well to observe how contemporary views about free speech and the robust influence of money -- whether legitimate or corrupt -- have on the pharmaceutical industry. The influence of the digital age on commerce and communication cannot be overstated. The strength of this influence is particularly evident in the article on off-label promotion (Berman, 2012) and the case of 23 andMe (Quelch, 2014).
That pharmaceutical companies are pressing to communicate and disseminate information about their off-label products on the basis of First Amendment rights is a clear indication that the tacit -- if not overt -- permissibility of digital culture has the capacity to threatens established safeguards. Indeed, with the ruling that First Amendment rights apply to corporations as entities, the Supreme Court further conditioned the public's acceptance of commerce having a non-regulated voice. A belief that the FCA's regulations unfairly and unreasonably curtail choice is underscored by the position of pharmaceutical companies (and ostensibly by consumers), and is illustrated by Allergan's statement that their freedom of speech can act "to assist physicians in evaluating the risks and benefits if they choose to use [Allegan's drug] off-label." In essence, this position asserts that FDA regulations are superfluous. What appears to be missing from recent Supreme Court decisions is recognition that digital communication overrides conventional boundaries of audience. That is to say that, the Supreme Court's view that the prescriber identifiable information need not be prohibited from marketing and promotion of prescription drugs, assumes a "sophisticated and experienced" audience of prescribing physicians: the exclusivity of this conceptual audience cannot be guaranteed in the digital age. Moreover,...
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