FDA and the Fifth Amendment

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). 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 end, and where potential profit is a key driver of decisions made at every level? Competition among pharmaceutical companies escalates when a drug patent is about to expire, and may well press decision-makers to forgo options that are best for patients for options that are best for stockholders (Ofek & Laufer, 2008).

The 23 andMe personal genome service (PGS) poses a unique challenge to a pharmaceutical manager as it is being marketed directly to consumers in the same manner as health related products that cannot be associated with the potential for drastic harm or dramatic benefit (Quelch, 2014). For instance, a television ad for a gel pad to increase comfort when sitting can make claims that range from improved spinal alignment to increased energy throughout the day without jeopardizing the health of the consumer who purchases the product.

The PGS being marketed by 23 andMe can pose considerable harm to consumers who attribute greater levels of confidence to the genetic data derived from the test results (Quelch, 2014). As a research driven agency, the U.S. FDA well appreciates the significance of false positive and false negative findings, for which robust statistical processes are routinely engaged in order to achieve levels of confidence that can be communicated within the scientific community -- and appropriately interpreted for consumers.

Without seeming prejudicial regarding the apparent hubris of executives from high tech companies or venture capitalists bent on the next best deal, it is difficult to ignore the fact that the CEO of 23 forMe, Anne Wojcicki, is the wife of Google co-founder, Sergey Brin, and that the vice president of marketing, Neil Rothstein, is formerly of Netflix (Quelch, 2014).

In light of the fact that her expertise is not medical research, it is more than a little disconcerting that Wojcicki is quoted as saying, "We're direct to the consumer not because it's easy, but because that's how you create a revolution" (Quelch, 2014, p. 1). The manner in which a revolution triggered by digital disruptive technology occurs, and the manner in which a revolution in medical science can occur are -- and must be -- decidedly different.

As a potential middle-party distributor for medical devices, a pharmaceutical manager must be acutely aware of the distinction, and what it means to the consumers who rely on the pharmacy as agents of scientific authority. The flagrant disregard of the FDA regulations by 23 andMe is disturbing, but it does not appear to be cut from the same cloth as the bribery described by Quelch (2013) in the GlaxoSmithKline in China case. It is common knowledge that bribery.