Off-label Use vs Off-label Marketing

Off-label Use and Off-label Marketing Are Different

Off-label use and off-label marketing, on the surface, sound similar but they are two distinct practices in the pharmaceutical industry and medical community.  Off-label use is a practice by which physicians prescribe an F.D.A-approved drug for an unapproved indication/dose/age/administration.  Sounds strange but off-label use has been widely and legally implemented in the medical community for a long period of time.  Off-label marketing, on the other hand, is a practice by a drug company to promote drug use in unapproved indications.  In other words, physicians are legally allowed to prescribe drugs for any purpose (based on their professional assessments), but companies are not allowed to promote drugs for unapproved uses by the F.D.A.

Off-label Use Example

An increasing number of antipsychotic drugs have been brought to market in recent years.  The earlier version of the antipsychotic drugs (aka typical or first generation antipsychotics) are mainly to treat schizophrenia, bipolar disorder, and delusional disorder.  Nowadays, more and more non-psychotic symptoms, like depression, anxiety, autism, obsessive compulsive, just to name a few, are treated more prevalently with newer version of antipsychotic drugs (aka atypical or second generation antipsychotics).  A recent research by groups at the Stanford University and University of Chicago showed that atypical antipsychotic drugs are prescribed frequently for non-FDA approved use that lack strong evidence to actually benefit patients.  This widespread post-market off-label use of the FDA-approved second generation antipsychotics needs to be monitored more closely should unknown side effects outweigh the benefits.  Aside from unproven benefits of off-label use, medicare and private insurance companies often deny coverage for off-label prescription.

Off-label Marketing Example

In September 2010, Novartis has agreed to pay a hefty $422.5 million fine for off-label marketing over six drugs (Trileptal, Diovan, Exforge, Sandostatin, Tekturna and Zelnorm).  One of the off-label marketing practices (blood-pressure drug Diovan) was revealed and kind of shocking as this marketing gimmick went too far that highlighted the unethical medical practices due to greed.

In recent months, Pfizer has been ordered to pay a $142.1 million fine for violating federal racketeering laws in the marketing of Neurontin (gabapentin), an anticonvulsant drug approved by the F.D.A. in 1993 for epilepsy indication.  Neurontin was marketed to be effective in treating bipolar disorder and migraines and was hidden for suicide risk.

On 28 February 2011, Elan Pharmaceuticals pleaded guilty of violating the Food Drug and Cosmetic Act for off-label marketing on its epilepsy drug Zonegran approved by the F.D.A. in April 2000.  Again, a hefty criminal fine of $97 million was paid.

Along the same line, several companies had faced serious legal and financial consequences from off-label marketing.  In the past few years, a handful of pharmaceutical companies had settled with federal government on their health care fraud, and here they are:

  • Pfizer: $2.3 billion
  • Eli Lilly: $1.4 billion
  • Allergan: $600 million
  • AstraZeneca: $520 million
  • Bristol-Myers Squibb: $515 million
  • Forest Laboratories: $313 million

Some Thoughts

One psychiatrist once told me that she has stopped using free pens given by drug companies as she later noticed that she wrote more prescriptions from the drug companies that brilliantly use their freebies to subconsciously influence a physician’s professional judgment.  How can a patient assure that a physician is not materialized in any way making prescription recommendation?  Is the drug prescribed based on the best interest/benefit for patient or off-label use for empirical reason or off-label marketing for kickback?  That said, with internet available at your fingertip, it is worth self-educating and doing due diligence on one’s prescribed drug.

Until next post, keep on reading and writing!!

About fdabiomed
I love to read and write about biomedical science and turn it into something memorable. I am passionate to learn new knowledge and information related to the Food and Drug Administration, specifically its decision and announcement on drugs that can impact human welfare and company's valuation.

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