Author: Dee Mahoney
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:
- 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.
- 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.
- 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:
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.
- 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.
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.
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)
- Off-label marketing of medicines in the US is rife but difficult to control (physorg.com)
- Under Investigation: 180 Qui Tams for Pharma or Device Fraud (goodpromotionalpractices.com)
- Off-Label Whistleblower Suits: Slower and Subtler (goodpromotionalpractices.com)