As the needs of healthcare professionals, and the goals and regulations of the industry evolve, so do the role of—and expectations for—medical science liaisons (MSLs). Those changes have generated discussions about many aspects of the MSL profession, from appropriate responsibilities to how companies can use those professionals most effectively. A previous column discussed how executives demonstrate MSLs' value to their organizations. ("MSLs: Show the Value," December 2004.) This month's column highlights the potential issues concerning MSLs and the dissemination of off-label information.
This is a good time for companies to examine the topic, given that the Office of Inspector General (OIG) noted in its 2005 work plan that it intends to scrutinize off-label promotion. But even without that spotlight, regulatory authorities' investigations of off-label promotion regarding Genentech's Rituxan (rituximab), Johnson & Johnson's Topamax (topiramate), and—the granddaddy of all cases—Pfizer's Neurontin (gabapentin), should cause companies to re-examine areas that are potential liability hot spots.
Off-Label Sales Reps
MSL programs have been expanding across the industry, fueled in part by the diminishing effectiveness of field-based sales forces. Companies now deploy medical liaisons to discuss clinical data at a level that sales reps often cannot. However, because of US Code Title 21 Food and Drugs, Chapter 9, Subchapter V, Part D, Section 360aaa (amended by Section 551 of the FDA Modernization Act), which allows pharma manufacturers to respond to physicians' queries about off-label uses for drugs, the danger of using MSLs as "off-label sales reps" is real.
That problem is exacerbated because many executives believe that FDA's "safe harbor" clause somehow grants MSLs special privileges to proactively disseminate off-label information. The simple fact remains that nobody can promote off-label—not sales reps, MSLs, R&D directors, nor physicians who speak on behalf of pharma companies (whom OIG calls "white coat marketers"). Regulatory agencies do not scrutinize the job titles or identity of the personnel conducting the activities, only the activities themselves. In other words, circumstances of communication are what counts, not who does the communicating.
Joint visits. However, some companies gamble with a false notion of safe harbor for medical liaison activities. Take the example of joint visits. A rep, thinking the MSL has complete regulatory freedom to "promote" off-label, will greet the physician and say, "Here's our MSL who can tell you about the use of drug X in (a nonapproved indication)."
The very act of joint calls is no indication of impropriety, but some legal consultants label them as "warning signs." In response, many companies no longer require MSLs to make joint visits with sales reps. Still, executives need to understand the dynamics playing out in the field to understand where other abuses occur.
Order takers. One big problem for industry deals with MSLs acting as "order takers" for sales requests. This may potentially happen through the following sequence of actions: 1) the rep sees a doctor's numbers drop off for drug X or discerns that the doctor has not "maximized the use" of drug X; 2) the rep requests that the MSL visit the doctor to talk about concerns about the drug or "other uses" of the drug that the doctor may not have considered; 3) the MSL visits the doctor, thereby "fulfilling the order"; 4) the rep follows up on the doctor's prescribing behavior.