Are Drug Companies Using Medical Staff to Circumvent Off-Label Promo Rules?

<"">Drug companies may be using employees known as medical science liaisons (MSLs) to get around rules that prohibit the promotion of unapproved drug uses, The Wall Street Journal reported today. Because MSLs are considered medical – not sales staff – they are allowed to discuss off-label uses of medications with doctors and other health professionals.

According to the Journal, MSLs are often doctors or pharmacists. They call on doctors to discuss the science behind a medicine, including unapproved uses.

Drug companies maintain MSLs and sales reps have different functions, and often pharmaceutical companies don’t pay MSLs incentives for sales in their territories, as is the practice with sales reps. But according to the Journal, some are concerned that the line between MSLs and sales staff are often blurred.

Dr. Jane Chin, president of the MSL Institute, a company dedicated to the ethical training of MSLs, told the Journal that she quit being an MSL because she was asked to work more closely with the sales team than made her comfortable. She also expressed concerns about MSL training, and the ways they deal with off-label information.

Drug companies appear to be hiring more MSLs, the Journal said. According to data on 12 major pharmaceutical and biotech companies collected by a market research firm, there were 48 percent more MSLs on staff in 2008 than there were in 2003. Meanwhile, the number of drug sales reps dropped to 90,000 in 2008 from 106,000 in 2006.

While doctors are free to prescribe approved drugs in any way they see fit, drug companies are not allowed to promote off-label uses. However, according to The Wall Street Journal, the firms may respond to unsolicited requests for information from doctors, including off-label data, if they provide truthful, nonpromotional material.

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