Marketing to Professionals: MSLs: Off-Label Promotion - Pharmaceutical Executive


Marketing to Professionals: MSLs: Off-Label Promotion
The "safe harbor" clause doesn't necessarily protect medical liaisons.

Pharmaceutical Executive

Some managers may ask MSLs to "see what they can do" for their sales colleagues if a product's sales have dropped, and they may coach liaisons to "be better partners" with their sales teams. This is technically not illegal, but it runs a risk—especially in companies where 360-degree feedback is used in personnel evaluations. Just imagine a sales manager measuring a MSL's performance and the pressures that creates for the liaison.

Fuzzy Lines Research and promotional intent do not have clear-cut definitions. Even though MSLs are focused on research and education, educational intent can sometimes assume a promotional air.

For example, a MSL may hold a research discussion with a physician that may fall within the category of "scientific exchange" but can easily migrate toward a promotional discussion. After all, "promotion" is a broad concept that applies to any affirmative representation of a drug, regardless of disclaimers. For example, stating, "This drug has shown some efficacy for this off-label use, but there is not enough data" may not get MSLs off the hook if they proactively initiated the discussion. Even when a liaison initiates a discussion about the science behind an off-label use, regulatory agencies may ask, "Why talk about the science behind the off-label use if your company is not intent on generating off-label sales?"

Only a discussion initiated by a physician's query about off-label information falls within the constructs of "safe harbor." However, it must truly be initiated from the professional. MSLs who employ elicitation techniques so that physicians ask questions about off-label uses may not have directly initiated the off-label discussion, but elicitation—no matter how cleverly it may be disguised or subtle—is still solicitation.

Companies need to carefully examine MSLs' and sales reps' activities and how they relate to off-label information. Whistle blowers are everywhere: most complaints to regulatory agencies come from irate physicians who were on the receiving end of an off-label discussion they believed posed safety concerns for patients. Competitors can also submit complaints about material perceived as off-label promotion, such as invitations to MSL-led dinner programs for a nonapproved drug use. Finally, MSLs themselves have contacted authorities with concerns about their own companies' subtle directives for off-label promotions. As OIG begins to make progress toward the goals set forth in its 2005 work plan, off-label scrutiny will gain even greater steam.

Acquisitions InChord Communications,a healthcare communications company, acquired Junction 11, a UK-based healthcare advertising agency. The new agency, which will be known as GSW Worldwide/Junction 11, will be based in London and will serve as the European hub for GSW Worldwide's global network. It will be led by Stephen Wheatley, who recently joined as president of the agency's UK operations. In a separate development, InChord acquired a 15 percent stake in Heart Reklanbyra, a Sweden-based healthcare advertising agency.

People Elaine Eisenhas been promoted to president of Corbett Accel Healthcare Group's Chicago office. A 12-year company veteran, Eisen had been executive vice-president and director of client services at the agency. Howard Jaffe has joined The Mattson Jack Group as vice-president, marketing research, and William Bagwell was promoted to the same position. The company focuses on business analytics, brand optimization, and corporate development services in the pharma and biotech markets. At Williams-Labadie, a Chicago-based healthcare communications and advertising agency, Cindy Miller was hired as vice-president, account management. Joe Soto, a long-time industry veteran, was named general manager of Dorland Global Health Communications' San Francisco office. Soto joined the company a year ago as executive vice-president. Phil Molinaro has joined Quadrant HealthCom as group publisher.

Launches MD Net Guidelaunched Cardiology eDigest, which will be issued bimonthly starting this year. Visit http://www.mdnetguidecom/. Vision Integration and Information Technology Professionals introduced a web-based technology that enables physicians to view and reply to pharma company-sponsored medical education events.

Jane Chin, PhD, is president of the Medical Science Liaison Institute.


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