Off-Label Marketing

Prior to a prescription drug becoming available for sale on the market, pharmaceutical companies must specify the intended uses of the drug in a New Drug Application (“NDA”) to the Food and Drug Administration (“FDA”) pursuant to the Food, Drug, and Cosmetics Act (“FDCA”) and submit the drug to years of clinical testing.  Pharmaceutical manufacturers cannot market their drugs in the United States unless the manufacturer demonstrates to the FDA through these trials that the drug is safe and effective for each of the uses proposed by the manufacturer.

The FDA does not approve drugs for general, but rather for treatment of a specific condition with a specific dose, for which the drug has been tested in patients.  The specifically approved use and dosage is called the “indication” or “on-label use” for which the drug may be prescribed.  A manufacturer seeking to market or promote an approved drug for uses that are not listed on the approved label must submit a Supplemental New Drug Application for the new use and resubmit the drug for another series of clinical trials similar to those for the initial approval.

Off-Label Use and Promotion

An unapproved use is considered to be an “off-label” use, unless and until the new use is approved by the FDA. The term “off-label” refers to the use of an approved drug for any purpose, or in any manner, other than what is described in the drug’s labeling. Off-label use includes treating a condition not indicated on the label.

After a drug has been approved for a particular use, the Food, Drug, and Cosmetic Act (“FDCA”) does not prohibit doctors from prescribing the drug off-label, but it does strictly prohibit drug manufacturers promoting a drug for a use that the FDA has not approved.  A manufacturer illegally “misbrands” a drug if the drug’s labeling—including all marketing and promotional materials relating to the drug—describes intended uses for the drug that have not been approved by the FDA.

These regulations protect patients and consumers by insuring that drug companies do not promote drugs for uses other than those found to be safe and effective by an independent, scientific governmental body, the FDA.  In addition to prohibiting manufacturers from directly marketing and promoting a product’s off-label uses, Congress and the FDA have also prohibited manufacturers from employing indirect methods to accomplish the same end.

Off-Label Marketing and Medicare/Medicaid Fraud

Off-label promotion by a drug manufacturer violates the False Claims Act because payment for off-label uses of prescription drugs by government-funded healthcare programs such as Medicare and Medicaid is highly regulated and restricted. Generally, drugs prescribed for off-label uses or dosages are not eligible for reimbursement under these programs.

Accordingly, when drug manufacturers promote their drugs off-label and persuade physicians to write off-label prescriptions for their drugs to beneficiaries of Medicare and Medicaid, the drug manufacturer has caused the submission of false claims for reimbursement for the drug to the government.

Commonly, pharmaceutical companies accomplish an off-label marketing scheme in the following ways:

  • Training sales representatives about off-label uses and dosages (typically higher than the approved dose)
  • Providing sales representatives with medical literature that endorses off-label uses
  • Providing financial incentives or kickbacks to physicians in exchange for writing off-label prescriptions
  • Paying physicians to promote off-label uses in speaking engagements or medical literature

Experienced Qui Tam Representation in Off-Label Marketing Cases

Kenney & McCafferty has a prominent track record of success in this area of False Claims Act litigation. Significant examples of successful off-label marketing cases brought by Kenney McCafferty include:

  • A $2.3 billion settlement with Pfizer
  • A $1.4 billion settlement with Eli Lilly
  • A $3 billion settlement with GlaxoSmithKline
  • A $520 million settlement with AstraZeneca
  • A $425 million settlement with Cephalon

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