It seems that federal prosecutors decided to throw the book (and then some) at the pharmaceutical giant Pfizer with a record-breaking $2.3 billion in fines for promoting so-called off-label uses of some of its drugs, most notably the arthritis drug Bextra. Pfizer was also called a repeating corporate cheat for illegal drug promotions that supplied doctors with free golf, massages, and resort junkets. The latter are indefensible, but the off-label prescribing issue deserves some reflection.
A drug is approved by the FDA for a very specific medical condition and companies are prohibited from promoting the drug for any other (unapproved) indications. So if a drug like Bextra is approved to treat arthritis the company cannot promote the drug for the treatment of post-surgical pain without FDA approval, even if there are data within scientific publications suggesting its possible benefits for this second indication. This is done often (though not always) for good reasons – avoiding the use of drugs with unknown effects (good or bad) in a new disease. But here is the kicker: physicians are allowed to prescribe any drug any time for any medical condition – whether the drug is approved or not for that condition. So the law permits drug companies to send information (mostly publications) on off-label effects of drugs only after physicians have requested it. The entire debate, then, in this off-label debate is where and how should physicians get the information that will enable them to prescribe drugs marketed for other uses, something they can do freely.
While there is a basic logic to the legislation (preserving physicians’ freedom but retaining reasonable regulation power to the FDA), this law seems too convoluted and can lead sometimes to ridiculous exchanges between physicians and pharmaceutical sales reps (who mentioned the off-label use first? Did the doc ask for a publication or did the rep volunteer to send it?). Any massive marketing campaign to promote an off-label use should, of course, be banned. Any one-on-one interaction between rep and doctor should be only of interest to regulators if the off-label use led to a serious harm, in which case the physician should be more liable than he otherwise would.
The amount that Pfizer has to pay, while “affordable,” is extensive and is designed to punish it, as well as deter others. With net income of $8.1 billion in 2008 (out of more than $48 billion revenues) this is a painful hit that will likely change Pfizer’s future behavior. On the other hand, one has to wonder whether applying $2.3 billion to R&D or investing it in other biotech drugs in development would have served our public better.