Articles by Levick Experts

Off-labeling, the practice of prescribing drugs for purposes other than those specifically approved by the Food and Drug Administration (FDA), is an increasingly common practice for doctors, but is can be a prescription for disaster for drug manufacturers, opening up a floodgate of legal issues and potential lawsuits.

Hard numbers are difficult to come by, but estimates of the practice involve anywhere from 20%-70% of all prescriptions written annually in the U.S. Even at the low end, the numbers are staggering in terms of potential liability. 

Physicians commonly prescribe drugs for uses not explicitly approved by the FDA when there is evidence from, say, a medical journal that a pharmaceutical is effective in treating a medical condition not specified on its label, or when no FDA-approved drug exists to treat a condition. 

A watershed event occurred in 2004 when Pfizer pleaded guilty to illegally marketing Neurontin – approved to treat postherpetic neuralgia – for unapproved use. Pfizer settled with the Department of Justice for $430 million, the second-largest ever in a healthcare fraud prosecution.

Because off-labeling increases the use of a drug, and therefore profits, it gives industry critics ammunition to support charges of corporate greed and irresponsible marketing. At the same time, off-labeling creates additional exposure when problems are uncovered that might not have otherwise become causes of action: with Neurontin, for example, an alleged high suicide risk.

To protect themselves, pharmaceutical companies must be seamless in every aspect of the communications process. At the very least, they must be extremely circumspect in a drug’s potential future applications or benefits if the label doesn’t support their claims.

It’s difficult to comply with laws if you don’t know what they are. Internal communications are therefore particularly important in proactively dealing with problems in areas like off-labeling. Define for all decision-makers – particularly decision-makers involved in product marketing – the correct language and parameters of what can be claimed or suggested in all marketing materials.

On the communications front, leverage the in-house prophylaxis. For example:  

• Document all internal communications and training to support a future legal defense and, just as important, to show interested outsiders, including the media, that the company has been sufficiently aware of off-labeling hazards to take extra steps to protect the public.
• Rehearse your crisis team for the next Neurontin-type disaster. Use similar fact patterns to that signal lawsuit, as it was the worst-case off-labeling scenario. If you can withstand an attack like the one on Pfizer, you can parry lesser sorties as well.
• Simultaneously advance arguments in favor of off-labeling. Strategically use those arguments to tell a more multifaceted story about off-labeling. The counter-offensive is already well underway as Internet scans clearly show. (Check out The Independent Institute, for example, at http://www.independent.org. This high-end public policy group posted an op-ed by a University of California at Berkeley scholar named Scott Esposito, who eloquently described the benefits of off-labeling in the Pittsburgh Tribune-Review.)

Pharmaceutical companies can thus fight on two fronts by planning ahead to counter legal attacks based on specific lawsuits and allegations – while seeding public opinion with the health benefits of off-labeling. Use the high-authority experts who are already out there to aggressively and responsibly disseminate your messages for you. The messages include:

• Off-labeling allows doctors to successfully determine the efficacy of drugs on their own and thus expand treatment options.
• Off-labeling puts more choice in the hands of the public.
• Off-labeling allows for responsible experimentation. Remember, public frustration with the FDA is just as frequently over treatments that people need but cannot get, as it is over drugs alleged to have been ill-advisedly approved.

AIDS activists and similar organizations are lobbying health-care providers to reimburse patients for off-label treatments. Pharmaceutical companies should look for ways to support them and, in so doing, forge alliances with groups that are often at odds with industry practices. The benefits of such alliances extend beyond off-labeling. It’s a great way to turn some enemies into friends or at least moderate their enmity.

Public communications, like politics, can make for some strange bedfellows.