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What is "Off-Label" Marketing?

Jason Reese

A lawsuit against GlaxoSmithKline PLC (GSK) is moving forward, alleging that the pharmaceutical company’s “off-label” marketing of their drug, Zofran, caused birth defects, including cleft palate, heart and kidney defects, musculoskeletal deformities, and fetal death. GSK had requested all claims be dismissed, but a judge has denied their motion.

When a drug company seeks approval under the Food, Drug, and Cosmetic Act, they must apply through the Food and Drug Administration (FDA). Part of this process is the submission of all intended uses for the drug. Once the drug is approved, it is illegal for the pharmaceutical company to advertise or otherwise market the drug for uses not specifically noted in its FDA application. The drug approval process is stringent and costly to pharmaceutical companies, both in terms of time and money. The result is that they often seek a way around the ban against “off-label” marketing if they believe their drug is appropriately indicated for a new use not previously approved by the FDA.

In most cases, it is fortunate for patients that physicians ARE allowed to prescribe medications for “off-label” purposes if they believe it is medically-appropriate and will not cause harm. This is common practice, especially with regard to the treatment of cancer, particularly pediatric cancer where the physical responses to the myriad of available treatments can be very individual. In general, providing doctors this freedom is beneficial to patients.

That said, the line begins to blur when pharmaceutical companies begin to find ways of influencing and incentivizing doctors to push their drugs for “off-label” purposes. Hundreds of millions of dollars have been paid by drug companies in cases related to illegal marketing, such as:

  • After the FDA rejected several “off-label” uses for Bextra, an anti-inflammatory medication, due to specific and identified concerns about the safety of the drug, Pfizer Inc. and its subsidiary, Pharmacia & Upjohn Company Inc., chose to actively promote the drug for the rejected uses anyway. Eventually, the two companies agreed to settle criminal and civil charges for a record-breaking settlement amount.
  • When Eli Lilly & Co. was forced to plead guilty to illegally marketing antipsychotic drug, Zyprex, for the treatment of dementia in elderly patients despite the fact that the drug had only been approved by the FDA for treatment of bipolar disorder and schizophrenia.

In some cases, doctors are even provided kickbacks for prescribing the drugs for “off-label” uses. Most “off-label” marketing suits are brought under the False Claims Act and hold criminal penalties for the companies. In many cases, the government is tipped off by former employees of the companies turned whistleblower. In even more tragic cases, the “off-label” uses of the drug causes significant injury to the patients, and in these cases, there is also the possibility of civil action and penalty.

Have you or a loved one been injured by Zofran or another drug prescribed to you by your doctor for an “off-label” use? If so, it is critically important that you seek the assistance of an experienced personal injury attorney who can help you navigate a complex medical and legal case and who will not back down from powerful drug companies. The Indianapolis-based attorneys at Wagner Reese have years of experience and can provide you the support you need to get the justice you deserve. Call us now for your FREE consultation: (888) 204-8440.


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