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Watch out for off-label drug promotion

While it is true we would never be where we are today without modern medicine, it is also true that pharmaceutical companies are out to make money. Sometimes they do this by putting patient safety at risk.

As a medical professional, you're in the best position to notice when pharmaceutical companies are promoting their drugs for off-label use. If you see this happening, don't be afraid to speak up.

What is off-label use?

The FDA approves pharmaceuticals to be used for specific symptoms and conditions, and in specific dosages. Any use that exceeds the scope of what the FDA authorized is considered to be "off-label."

It is against the law for pharmaceutical companies to promote their drugs for off-label use.

What does off-label promotion look like?

Off-label promotion occurs any time a drug company encourages a physician to use its medications for a non-FDA approved purpose. Some of the most common types of off-label promotion include the following:

  • Giving kickbacks to physicians for off-label prescriptions
  • Sending physicians to vacation destinations to learn about off-label use
  • Paying physicians to serve on "advisory boards" promoting off-label use
  • Teaching prescribers how to code claims to get insurance to pay for off-label use
  • Distributing flyers or other promotional materials encouraging off-label use

Why is off-label use bad?

Off-label use is dangerous because it can put patient's lives and safety at risk. If a usage has not been FDA approved, there is no way of knowing that it is safe.

Off-label usage also costs taxpayers money when Medicaid funds are used to pay for treatments that would otherwise not be covered.

What can you do about it?

The federal government encourages medical professionals to report off-label promotion when they encounter it.

In fact, the government actually offers a financial reward for doing so. Whistleblowers who report this type of misconduct can be awarded a substantial percentage of the penalty paid to the government. It is against the law for employers to retaliate against employees for reporting off-label use or promotion.

If you've witnessed off-label use or promotion in your facility, the next step is to talk to an experienced attorney. The lawyer can help you understand your options under the law, and the best path for moving forward.

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