We’ve been warned. Recent settlements between the U.S. Department of Justice (DOJ) and several FDA-regulated drug and medical device manufacturers serve as a prelude to future DOJ enforcement activity involving off-label promotion.

The DOJ and the U.S. Food and Drug Administration (FDA) are once again focusing on cases where false or misleading promotional messaging for drugs and medical devices appears to encourage the prescribing of products for uses that are unsafe, ineffective or medically unnecessary. For evidence, look no further than publicized prosecution in a number of recent cases, including the settlements by Dusa Pharmaceuticals and Avanir Pharmaceuticals.

In addition, the DOJ acting under the Biden administration has explicitly stated its investigators are going to look more closely at off-label promotion that in the past might have gone unnoticed. That means pharmaceutical and medical device companies should prepare for a dramatic shift in inquiries and enforcement.

Explicit and implicit off-label promotion

The FDA prohibits companies from marketing medical devices and pharmaceuticals for uses unapproved by the agency. Off-label promotion comes in two forms: marketing a device or drug that has not received FDA approval, or promoting an approved device for an unapproved use.

Off-label promotion can be explicit or implicit. Explicit off-label promotion occurs when a manufacturer makes direct claims about a product to promote it for an unapproved use. Implicit off-label promotion occurs when a manufacturer indirectly suggests a device is appropriate for an unapproved use.

Take for example a medical device company that manufactured a product cleared for use as an adjunctive diagnostic screening device. The company received a warning letter from the FDA because the agency suggested its promotional materials implied that the device could be used as a standalone test.

Companies engaging in either kind of off-label marketing face regulatory, civil and criminal consequences. A case involving Pfizer and the promotion of its anti-inflammatory drug, Bextra in 2009 illustrates the severity of the penalties involved. The company settled the case with the government for $2.3 billion and two company executives face prison time in connection.

In recent years, most of the enforcement actions for off-label promotion have focused on drug companies. However, the FDA, the United States Office of Inspector General (OIG) and the DOJ are increasingly paying attention to off-label promotion in the device industry, signaling that device companies may eventually receive the same level of scrutiny as their pharmaceutical counterparts.

What companies can do

Companies have always faced considerable regulatory risk when it comes to product promotion. After all, “false and misleading” is often a judgment call. Companies now will have to be certain their marketing and promotional language steers clear of any gray areas, let alone the red zone of false labeling.

The DOJ has made it clear that printed, broadcast or digital promotional materials on social media must be supported by medical literature or clinical evidence if they are to stand up to scrutiny by regulators and plaintiffs’ lawyers.

A recommended compliance step is to have your materials carefully reviewed before publication by a qualified medical professional, preferably one with impeccable credentials and not salaried by the drug, nutritional supplement or medical device company selling the products being promoted. Factual information is essential in protecting a company against questions which government investigators, the news media or consumer advocates are likely to ask in the future.

There’s no doubt the DOJ will interpret off-label promotion more strictly and judge it more harshly than it has in recent years. Because of this, manufacturers must take a cautious approach and eliminate any claims or activity, including suggestive inferences, that could be considered off-label promotion.