TREAD CAREFULLY when it comes to off-label discussion: That was the message that came through loud and clear in a 90-minute audioconference called, “Off-Label: Compliance Lessons for Marketing, Sales, and Medical Science Liaisons,” held in early March by HCPro, Marblehead, Mass. As presenter Jane Chin, PhD, said, today's regulatory and legal climate “gives a new meaning to ‘clinical trial.’ Now it's clinical trial by jury.” Chin is president, Medical Science Liaison Institute, and managing partner, MSL International Enterprises, a consulting organization based in Redondo Beach, Calif. Companies need to train their medical science liaisons, or MSLs, and sales reps about what is and is not going to land them — and their companies — in hot water with the feds, she said.
Despite regulations including the Federal Food, Drug, and Cosmetic Act and the Food and Drug Administration Modernization Act in 1997, there still are a lot of gray areas when it comes to off-label drug promotion, said panelist Bruce Armon, Esq., a partner in law firm Saul Ewing LLP's business department in Philadelphia. In addition to last spring's judgment against Pfizer for its Neurontin marketing practices, the feds also are investigating Johnson & Johnson, Wyeth, AstraZeneca, and Eli Lilly, as well as biotech companies including Cephalon and Genentech.
And it's not just the feds: States also are taking an interest in investigating off-label promotion. Then throw in product liability, commercial liability, and even physician liability for improperly prescribing and failure to warn, and the landscape looks even bleaker for those who don't train their sales reps and MSLs on where to draw the line between promotion and education.
According to Chin, the role of MSLs, many of whom have extensive healthcare training and often MD or PhD degrees, is to serve as peer-to-peer relationship-builders with physician thought leaders. The inherent danger in their position as scientific educators is, she said, “where does scientific exchange end and promotional exchange begin?” — especially since they often work in conjunction with the sales force. “Their role must be clearly defined.”
Debunking the Myths
The misconceptions about what MSLs can and can't do are legion, Chin said. “The FDA doesn't regulate by job title.” Sales reps need to know that MSLs can only discuss off-label uses when a physician's request for the information is truly unsolicited. “MSLs are thought to be able to sway doctors toward asking about off-label use, but solicitation, no matter how clever, is solicitation. It won't get you off the hook.”
William Janssen, Esq., the chair of Saul Ewing's Life Sciences Industry Service Team and a member of its Litigation Department, added that the intent is key for investigators. If a rep notices a drop-off in doctor X's drug Y prescribing, then asks an MSL to visit the doc to talk about “other uses” of the drug, the intent is pretty clearly to promote drug Y's use in a market that's declining, not to educate the physician.
“Sales reps need to be continually re-educated on how MSLs and reps can interact safely,” said Chin. But it starts at the top, said Armon. Companies need to develop — and continually update and monitor — guidelines, and make sure there is accountability at all levels Chin added that companies should not look at MSLs as their sales force of the future. “MSL deliverables are relationships, intangibles, unlike sales deliverables, which are tangible.” As one MSL told Armon when he asked her how MSLs affect return on investment, “‘We don't. We contribute to return on education.’”
When asked if only MSLs can address unsolicited off-label questions, the panelists said that technically and legally, anyone can respond. How-ever, said Armon, “many companies are very specific about sales reps not responding to off-label questions.” Chin added, “Most companies don't want to assume that risk, even if they can.” Some MSLs in the audience also worried that having two physically separate booths for sales and education at aisn't enough of a firewall. “As long as the question asked is unsolicited, it's OK” for a salesperson to send a physician to the MSL booth to learn about off-label usage, said Chin.
Janssen said that, when in doubt, ask yourself this question: “‘If what I do was displayed on a two-foot-by-four-foot poster in front of a jury, would I wince?’ If so, don't do it.”