Off-label marketing is the promotion of drug use for unapproved applications to gain more profit while putting patients’ health and wellbeing at stake. Off-label marketing is a type of pharmaceutical fraud that can result in legal action and heavy fines.

In the United States, the Food and Drug Administration (FDA) regulates marketing campaigns enacted by drug companies. The FDA works to catch any pharmaceutical fraud schemes that employ off-label marketing for higher profits and takes action against companies found violating laws and regulations.

Drug companies who fail to comply with the FDA may face lawsuits, criminal fines, and other punishments, which can cost these companies a lot of money and possibly ruin their reputations.

What Is Off-Label Drug Promotion?

Off-label marketing is an umbrella term covering all sorts of drug marketing schemes that promote off-label drug use. Off-label drug use is when a patient takes a medication to treat a symptom or a condition that the medication was not approved to treat. The term also refers to prescribing a drug in unapproved dosages or to an unapproved patient group.

Drug manufacturers or physicians who do not comply with the FDA-approved uses of a drug can be charged with unlawful off-label promotion under the False Claims Act and the Department of Justice. The approach behind this law is to make sure that the pharma industry prioritizes safe and effective treatment of patients over business profits.

Actions Recognized as Off-label Marketing

Whether you work in the pharma industry or rely on prescription drugs and medication for different health conditions, recognizing the signs of off-label marketing is essential. We have listed some common signs that indicate off-label marketing.

  • Drug advertisements that hint at unapproved benefits or include misleading content
  • Drug companies who pay incentives to their sales representatives for selling higher numbers of particular medications
  • Offering free samples of prescription drugs for off-label purposes
  • Providing doctors with kickbacks for prescribing certain drugs
  • Influencing the decisions of insurance providers by giving them false information about drugs
  • Going through patient charts to filter out target consumers and market the drug to them through different channels
  • Paying doctors to support off-label usage of medications by pretending to be the author of the content that encourages off-label use.
  • Paid lectures in support of off-label drug use given by physicians or medical professionals

Why Is it Illegal to Sell Drugs for Purposes Not Approved By the FDA?

Drugs are supposed to benefit patients by treating different health conditions while avoiding any unwanted reactions. That is why the FDA approves drugs for defined health conditions in a specific group of patients after determining the drug’s effectiveness, side effects, and other features.

Thus, it encourages the approved dosage for the approved group and prohibits unapproved usage. However, when drug manufacturers and others selling medications prioritize their business over a patient’s wellbeing, they employ off-label marketing methods.

Off-label drug use can lead to many serious medical complications, which is the primary reason why it is illegal for pharmaceutical companies to engage in off-label marketing.

What Is Whistleblowing and How Does it Relate to Off-Label Marketing?

It is a national responsibility to report offensive activity related to off-label drug marketing. In pharmaceutical terminology, the act of reporting off-label marketing and other such offenses is known as whistleblowing. This term refers to the actions taken to raise concern against any wrongdoing or malpractices prevailing in the pharmaceutical industry.

The term also covers the discussion and reporting of substantial risks occurring due to drug usage. If you witness any activities that are considered off-label drug marketing, you can take action by contacting a whistleblower attorney and reporting the misconduct to proper authorities.

It is important to note that it can be challenging to spot illegal off-label drug promotions due to several factors. Companies might rely on verbal commandments that are different from written regulations while communicating with their sales team or doctors. Even with written communication channels, companies can delete the conversations to avoid legal action.

Similarly, doctors prescribing drugs based solely on the symptoms instead of looking at the patient’s history with a particular health condition may also not get caught. Nevertheless, the FDA and other legal authorities can catch pharmaceutical companies involved in such crimes with proper investigation.

Whistleblower Info Center Is Here to Help!

If you witness signs or have evidence that a pharmaceutical company is marketing medications for off-label purposes, it is important to report the behavior and stop the malpractice. However, you must go about doing so the correct way.

If or when companies catch wind that you are exposing their fraudulent activities, they will try to utilize any loophole they can find to avoid having to pay fines and punitive damages and being subjected to criminal punishments. Evidence has to be appropriately collected, and you need to taken action through the proper legal channels.

A whistleblower attorney who is well-versed in all facets of whistleblower law and False Claims Act liability cases will be able to help guide you through what will almost certainly be a long and tumultuous process. Whistleblowing is a noble act, and there is potential that you could receive financial rewards for your troubles, but nothing is guaranteed.

If you decide to go through with blowing the whistle, make sure to reach out to Whistleblower Info Center for legal guidance throughout the entire process. Give us a call at (888) 764-8645 or email us at We’re here to help!