An Off Way to Promote Off-Label?

Pharmaceutical companies can't market unapproved or "off-label" uses for their prescription drugs, under U.S. Food and Drug Administration (FDA) rules. But the same companies' medical science liaisons (MSLs), "who are considered medical rather than sales staff, have greater freedom than salespeople as they visit doctors offices to discuss the science behind a medicine, including unapproved uses," reports the Wall Street Journal. Moreover, the number of industry MSLs is increasing. Dr. Jane Chin, a former MSL for Aventis and Takeda Pharmaceuticals, quit after being "pressured to do more for the sales team. ... Some pharma companies have the impression if you just hire somebody [with a professional degree] and you call them an MSL, it doesn't matter what they say." She now heads the MSL Institute, which provides ethical training. Novartis, "which has one of the largest MSL staffs in the industry," says it buffers its MSLs from marketing pressures by not giving MSLs "incentives for sales in their territories." The FDA allows "drug companies to respond to unsolicited requests for information from doctors, including off-label data, if they provide truthful, nonpromotional material."