Direct to consumer marketing of prescription drugs

I’m taking this class on drug and device law, where we get to say things like “MDUFA” (pronounced ‘mah-doo-fah’) and “PDUFA” (pronounced ‘pee-dee-ewe-eff-ay’ – haha, jk, it rhymes with “Paducah,” or “Palooka”) and where we have phrases like “adequate directions for intended use” and “intent to introduce into interstate commerce misbranded or adulterated drugs” drilled into our heads.

 

One of the questions the profs keep trying to engage the class on is, if you were designing a legal and regulatory scheme from the ground up, would you still have the most salient features of our system – premarket approval of new drugs, for example? Would you still have the same standard for labeling (indication) claims, and how would you handle off-label use of drugs or devices? All of which is interesting, and really, for people who are my age and who have spent a good chunk of their adult life in a world where prescription drug manufacturers spend eight or nine billion dollars annually on advertising, it’s hard to think back to what life must have been like before the restrictions of direct-to-consumer (DTC) marketing of prescription drugs.

 

When asked point blank whether this was a good thing or not, I said I supposed so, since I wouldn’t have known about “restless leg syndrome” without it, and the follow-up question – “is that a good thing or a bad thing?” - took me a little by surprise. Most people in the class reasoned that ultimately it’s not bad to inform patients of treatment options and of drugs that might help them with their treatments and that on the balance, the good outweighed the bad – not to mention that the historical proscription against DTC promotion might not survive a first amendment challenge today. But I kept coming back to the idea – the question, really – of why, if we all agree that the social or public utility here is about information, does Cymbalta have a theme? (It gets stuck in my head for days at a time.) Why are so many of the commercials designed to include emotional cues? Those commercials may ostensibly be about informing, but they’re also about creating an emotional connection with the viewer and are largely designed to titillate the senses, if you will. I know this is a fairly obvious point I’m making here, but wouldn’t the obvious conclusion, when watching these commercials, be that their intent is to sell a product rather than to inform?

 

None of the smartypants law students had an answer for me on that score. So I’m congratulating myself for judo-chopping your Socratic methodology, Georgetown Law Center. So. Crates.