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Drug Co. MSLs Can Discuss Off-Label Use

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The Wall Street Journal has an interesting article about one of the ways drug companies could legally circumvent rules against off-label drug promotions.   The use of  medical science liaisons (MSLs) – personnel considered to be part of a drug firm’s medical staff – could allow companies to communicate information about off-label uses  to doctors in ways that traditional drug reps cannot.

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.

Often, MSLs are responsible for responding to such requests.  According to the Journal, MSLs are often doctors or pharmacists. They call on  doctors to discuss the  science behind a medicine, including unapproved uses.   But some fear the function could be abused.

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 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.

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.

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