GlaxoSmithKline’s $3 billion settlement with the government earlier this month – exceeding Pfizer’s $2.3 billion and Eli Lilly’s $1.4 billion settlements in 2009 and AstraZeneca’s and Novartis’ settlements in 2010 – marked the latest of several cases brought against major pharmaceutical companies, in part, for illegally marketing prescription drugs.
The Glaxo case included marketing practices dating to the late 1990s and extending into the mid-2000’s. FDA inaugurated its “Bad Ad Program” in May 2010, as part of its effort to keep pace with contemporary drug marketing activities. Figures from the Congressional Budget Office suggest that Pharma spends three times more on advertising to health care professionals than to consumers. By encouraging health care professionals to remain vigilant for misleading or inaccurate promotion of prescription drugs – and by making it easier for them to report suspected violations directly to the agency – the Bad Ad Program reveals an FDA conspicuously engaged in an effort to increase its surveillance capability. Not coincidentally, the Bad Ad Program also holds the promise of allowing the agency to reach activities which traditionally the agency has had difficulty penetrating: Interactions in doctors’ offices, local lunch/dinner programs and speaker programs are all examples cited by FDA. The Government Accountability Office had previously concluded (July 2008) that, while FDA attempts to monitor violations outside of its review of formally submitted sales materials, the agency was hampered by its inability to reach the many different forums in which pharma sales representatives can promote products to health care professionals. The Bad Ad Program can address this core difficulty.
From 2010 to 2011 FDA officials attended fifteen (15) medical conferences to spread the agency’s message about the need for and the ease of reporting potential drug marketing violations. According to the agency’s own numbers FDA’s efforts met with some success – health care professionals submitted 188 reports, with almost half justifying comprehensive review by FDA staff, a significant increase from previous years. Some of these reports were highly detailed, with health care professionals providing dates, times, locations and the specific statements made by sales representatives. FDA intends to maintain and extend the Bad Ad Program through continuing education and enhanced outreach to medical, pharmacy and nursing students. The program should therefore be expected to be a long-term feature of the compliance landscape.
This obviously increases pressure on Pharma compliance and regulatory professionals. Sales and marketing personnel are, by nature and training, competitive in promoting the benefits and virtues of their companies’ products. Recent warning letters have shown FDA pursuing not just the promotion of unapproved uses, but also unsubstantiated superiority claims, risk-minimizing statements and unsubstantiated mechanism of action descriptions – exactly the kinds of statements which may be made incautiously, in the heat of the moment, during unguarded and apparently informal conversations with providers. Complicating matters, sales representatives also may be inclined to view their promotional activities with providers as personal and their communications with health professionals as at least somewhat private. The Bad Ad Program, in contrast, reminds and challenges health care professionals to view these interactions very differently. Regulatory and compliance professionals must therefore insist that communication between sales or marketing personnel and health care professionals be viewed and used as (1) primarily educative, as opposed to competitive; and (2) public, regardless of the setting.
This becomes imperative in light of the agency’s shift to a more enforcement-oriented approach, exemplified by FDA’s apparently renewed interest in the Park doctrine (permitting the imputation of misdemeanor offenses to senior corporate officers who are in a position, but fail, to act to prevent violations of the Federal Food, Drug, and Cosmetic Act). FDA’s willingness to resort to Park to curb unlawful marketing practices was expressed most bluntly by FDA’s Deputy Chief of Litigation, Rick Blumberg, who stated publicly in October of 2010 that “[u]nless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion.” Through the Bad Ad Program FDA has the very real possibility of generating the raw material which will allow it to do so.