What Is “False or Misleading” Off-Label Promotion?
In the late 1990s, the drugmaker GlaxoSmithKline obtained some exciting research results about the antidepressant Wellbutrin. Rather than interfering with sex drive and sleep cycle like many competing products, Wellbutrin appeared to have positive side effects, like suppressing appetite and reducing cigarette cravings. GlaxoSmithKline could have sought formal endorsement of these findings from the FDA. Instead, the drugmaker embarked on a marketing campaign that would lead to one of the largest health care settlements in history.
A federal complaint describes how GlaxoSmithKline executives designed and systematically executed “Operation Hustle” to perform follow-up studies and generate buzz about the use of Wellbutrin for conditions that frequently accompany depression, including weight gain, sexual dysfunction, and attention deficit hyperactivity disorder. The firm sponsored group seminars to provide physicians with details about the scientific support for its claims and dispatched sales representatives to doctors’ offices to tout Wellbutrin as a “happy, horny, skinny pill.” Though GlaxoSmithKline’s tests lacked FDA endorsement, the firm’s marketing strategies worked. Sales increased by a third in less than a year.
GlaxoSmithKline’s successful campaign led to a slew of lawsuits accusing the company of promoting drugs for unapproved (“off-label”) uses. None of the complaints, however, actually claimed that GlaxoSmithKline had made false or misleading statements about Wellbutrin. The complaints acknowledged that physicians who prescribed Wellbutrin understood the promotional nature of GlaxoSmithKline’s messaging. One complaint even recounted how a physician described the company’s seminar speaker as a “drug whore.” In fact, despite all the negative publicity, Wellbutrin remains a hugely popular drug, with some prominent physicians endorsing the scientific support for its beneficial side effects.
The Wellbutrin story raises difficult questions about how to distinguish harmful off-label marketing from information that physicians find useful when making prescribing decisions. In particular, how should courts determine whether a physician’s reliance on off-label claims is the result of useful education as opposed to successful duping? Since the Wellbutrin case settled, developments in the federal courts have brought this question to prominence. This Comment provides an answer.