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Changes To Off-Label Drug Promotion Laws On The Horizon?



I’m not going to get into whether prescribing or using drugs for off-label purposes makes sense – you can decide that for yourself. However, what I will tell you is that it’s a hot topic in the industry right now. Pharmaceutical companies continue to lobby the FDA to eliminate any prohibition of off-label promotion by drug reps to physicians, as doing so could encroach on free speech. 

The current regulations state that physicians can prescribe drugs that are for medical conditions outside of the approved use(s) listed on the label; however, pharma companies can’t advertise or promote the use of their products for conditions not yet approved by the FDA.

According to WebMD, more than one in five outpatient prescriptions written in the U.S. is for off-label therapies. What’s more fascinating is that any one of us (you and me included), could have been prescribed medication for an off-label use and simply not know it, as physicians aren’t required to tell patients about a drug’s approved use(s).

Naturally, any rule change could significantly impact the industry and the patients it serves, so we’ll be watching this case closely.

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Eugene Sefanov

Director, Industry and Regional Marketing

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