Using healthcare professionals to market products is not illegal, but has gained considerable scrutiny from authorities.
Late last year, the pharmaceutical industry faced a slew of whistleblower lawsuits in federal courts, all with remarkably similar allegations. These complaints uniformly alleged that a large number of drug manufacturers used improper “white coat” marketing techniques to sell pharmaceutical drugs. The complaints alleged that large manufacturers hired nurses and physicians to hawk their products, thereby confusing unwitting patients.
The lawsuits gathered splashy headlines, in large part because the whistleblowers alleged that pharmaceutical companies had made billions of dollars through these allegedly inappropriate practices. These lawsuits are still unfolding in federal courts across the country.
Given the increase of lawsuits and the high stakes that companies face in defending these claims, drug manufacturers would be well served by understanding the rules governing marketing of pharmaceutical products. We outline the basic legal framework and then offer some practical advice to avoid allegations of wrongdoing.
White Coat Marketing, in General
As a general matter, white coat marketing refers to the practice of physicians, nurses, and other professionals advertising or marketing pharmaceutical products. To be clear, using healthcare professionals to market or advertise products is not unlawful or illegal; however, the government has historically viewed white coat marketing more cautiously because physicians and other health care professionals are in a position of public trust, and thus may exert influence when recommending healthcare-related items or services. The government has often argued that, given the nature of these relationships, when healthcare professionals market items to their patients, patients may have difficulty distinguishing between professional medical advice and a commercial sales pitch.
The government has also raised concerns not just where practitioners directly market products to patients, but also where these professionals act as “consultants,” “advisors,” or “researchers” in connection with marketing and research activities. For instance, the government often casts a skeptical eye on arrangements where pharmaceutical manufacturers engage physicians to perform research, data collection, and consulting services, to serve on advisory boards, or to speak at meetings.
Practical Advice on Avoiding White Coat Marketing
Given the government’s skeptical nature of these arrangements, and given the number of lawsuits nationwide, practitioners, and pharmaceutical manufacturers alike would benefit from taking a cautious approach. While there is no exhaustive list of factors that will insulate a provider or manufacturer from government scrutiny, here are a few common-sense suggestions:
Again, these tips will not obviate all potential questions from regulators. But, as the old adage goes, an ounce of prevention is worth a pound of cure. Nowhere is this maxim truer than in the world of modern regulated medicine.
About the Authors
A. Lee Bentley III is a partner at Bradley, operating out of the Tampa, FL and Washington, D.C. offices. Previously, he served as the United States Attorney for the U.S. Attorney’s Office fo the Middle District of Florida in Tampa, where he oversaw more than 120 civil and criminal prosecutors. His office led in the number of qui tam cases prosecuted and helped collect more than $1.2 billion in criminal and civil actions.
Jason P. Mehta is a partner at Bradley, operating out of the firm’s Tampa, FL and Washington, D.C. locations. Mehta joined the practice in 2018, after serving for five years as an Assistant United States Attorney federal prosecutor for the United States Attorney’s Office in Jacksonville, Florida. There, he worked on various civil and criminal litigation matters, ultimately recovering nearly a quarter of a billion dollars for the federal government. Mehta now counsels private healthcare, banking, and other companies on compliance and practice defense strategies.