Top Three Off-Label Marketing Strategies and Tactics


The most common strategies and tactics used by pharma companies to engage in off-label marketing is explored in detailed in “Strategies and Practices in Off-label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints,” by Aaron S. Kesselheim, Michelle M. Mello and David M. Studdert from Harvard  and Brigham and Women’s Hospital and published in PLoS Medicine

While physicians can legally use FDA-approved drugs “off-label,” manufacturers who promote their drugs for off-label uses can be held accountable for charges of marketing fraud. Despite regulatory restrictions, the practice of off-label marketing seems to be quite common. In recent years, the majority of reported off-label marketing fraud cases are brought to the attention of the government by whistleblowers.

The authors conducted structured reviews of unsealed whistleblower complaints related to off-label marketing against pharmaceutical companies filed between January 1996 and October 2010 that resulted in US federal fraud cases.

By examining this data, the authors uncovered the top three Off-Label Marketing Strategies:

  1. Expansion to unapproved disease entities
    The most prevalent strategy involves expanding use on the basis of diagnosis—that is, seeking off-label uses for disease entities distinct from those approved by the FDA. For example, selling a product that only has an indication for pain associated with osteoarthritis for general pain relief.
  2. Expansion to unapproved indications
    The second most common strategy is expanding the product’s use to different variations of the same condition. For example, a product specifically approved for a severe manifestation of a condition is promoted for milder forms.
  3. Expansion to unapproved dosing strategies
    The third most common strategy is promoting different dosing regimens than those approved by the FDA.

The authors also detailed the most common Off-Label Marketing Tactics:

  1. Prescriber-related
    According to the complaints, off-label use was frequently encouraged through self-serving presentations of scientific literature giving physicians false or unbalanced data supporting the unapproved use. For example, promoting unsubstantiated superiority claims and providing financial incentives.
  2. Company-wide internal
    All practices described were reported to be company-wide rather than the work of an individual manager or group of managers. For example, setting unrealistic sales goals and encouraging these practices at sales strategy meetings.
  3. Payer-related
    Reports of discussions with prescribers in complaints described efforts to educate them about how to manage the billing system to ensure that off-label prescriptions would be reimbursed, including advice on ways to bypass insurers’ restrictions on prescriptions of the product.
  4. Consumer-related
    The most common example involved identifying consumers who could be treated by this off-label use.

The authors conclude: “Off-label marketing has been ubiquitous in the health care system and features some behaviors and strategies that may be resistant to external regulatory approaches. Our findings suggest that no regulatory strategy will be complete and effective without physicians themselves serving as a bulwark against off-label promotion.” (i.e. Bad Ad Program)

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6 responses to “Top Three Off-Label Marketing Strategies and Tactics

  1. Pingback: Medical Device Executives Found Guilty | Good Promotional Practices

  2. Pingback: 4 Synthes Execs Indicted for Off-Label Promotion | Good Promotional Practices

  3. Pingback: 7 New Insights to Preventing Off-Label Sales Promotion | Good Promotional Practices

  4. Dee, I’ve just started working in publications for a device company. The last time I worked on the marketing side FDA has just begun regulating promotional activities more carefully, so I’m on a bit of a learning curve. My question today is about publications covering off-label uses. Is there any way industry can safely promote the dissemination of data on off-label use? Assuming it is balanced and industry follows the currently guidelines on how the manuscript is prepared, who is involved, etc. – can this be done? We do have a need to educate on performance of the therapy when different types of lesions are treated in different anatomies (often compromised).

    • Hi Lois,
      Thank you for your question. Companies may not “promote” products for off-label use. A representative from the company’s medical department my respond to an unsolicited request regarding off-label information. You should refer to a companies dissimenation of medical information policy regarding how to disseminate clinical data that is not in a product’s label.

  5. Pingback: Off-Label Promotion Analyzed, Fixes Involve Docs « Health and Medical News and Resources

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