FDA and the Fifth Amendment Term Paper

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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, the same dynamics that enable a blitzkrieg of election campaign ads by wealthy PACs can freely operate in the arena the Supreme Court has defined, in which "divergent views regarding detailing and the prescription of brand-name drugs…[are debated through] free and uninhibited speech" (Berman, 2011, p. 35).

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Moreover, a Vermont physician testified that, "information is not in itself harmful, that people will perceive their own best interests if only they are well enough informed" (Berman, 2011, p. 35). This argument is tantamount to the economic theory of efficient frontier, which assumes that one cannot beat the market as all investors share all available information equally. Nobel Prize winning economists in this decade have demonstrated the flawed basis of efficient frontier through behavioral economic: that is to say that, people often make irrational investment decisions and all of the information cannot be shared equally -- the concept is only a theoretical truism. In modern society, access to information increasingly comes with a price. Preferred online content is locked until purchased. Broadcast advertising is skewed toward the dollar. An astute pharmaceutical manager would do well to ask how it is that the pharmaceutical industry, exactly, is exempt from these dynamics and practices.

Regardless of the hue and cry from educators for increased focus on a new literacy that underscores critical thinking applied to the Internet and all it affords, consumers are being conditioned to trust what they read online, to freely offer their own opinions -- whether absent any authentic authority or not -- and to champion those who eschew stuffy, old-fashioned standards of journalism and scientific thought. Consider, for instance, that Sage Publishing -- a long-time stalwart evidence-based research publishing house -- now offers a separate online publishing service to practically any university student who has been shuttled aside by juried periodicals. Just as physicians experience bombardment of lay knowledge about medicine gleaned from the Internet, pharmacists can expect consumers to make requests for drugs and devices that have been popularized outside of conventional scientific bounds.

Taking it a step further, how can the pharmaceuticals industry police itself in the product development stage where research and clinical trials extend for years on….....

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https://www.aceyourpaper.com/essays/fda-fifth-amendment-2153592
   

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