My question to the DTC community is why can’t we come together with FDA and make DTC advertising more understandable.
I am not talking just about risks but also benefits and indications. We are all letting the approved label dictate how we say what we say. That label information is generally not consumer friendly. Consumers see advertising, not as a whole sales pitch, but merely the start of a buying process. DTC, because of regulations, seems to be treated as requiring an entire pitch where virtually everything must be discussed. Look at cancer advertising for example on non small cell lung cancer. I’ll use Keytruda as an example which is required to say it is indicated if PD-L1 is positive and there are tumors with no abnormal EGFR or ALK gene. Huh? Merck has to say it but does any consumer know what any of that means? I doubt it.
What we have are technically oriented government regulatory bureaucrats in a non-technical DTC world. They should spend their time making sure everything said is true but also understandable. Instead of forcing Merck to discuss abstract qualifications on who might benefit, consumers would be better served knowing more about clinical results. Wouldn’t it be better to say Keytruda only benefits a segment of lung cancer patients and only your doctor can say if you might benefit? After all, patients do not self diagnose PD-L1 or their gene abnormalities.
FDA can make the 60 or 90 second ads much more consumer friendly and increase comprehension if they acted more like common sense regulators. They know many ads are data crammed and difficult to follow but it is their view that the label is like the Ten Commandments. Thou shall not deviate. So we get required language that is just wasting valuable air time that might be redirected towards giving consumers information they need and more importantly understand. I know Merck would probably like to do that. I also think OPDP would like it that way because I know the people there are trying to do right. Do we really think Congress intended consumer confusion in the 1970s when they wrote the regs never contemplating DTC?
Has OPDP pushed back on the Congressional committee regulating drug promotion that we need new promotional regulations? We can recognize that consumers just want mass media advertising to inform them that something might help them. They do not need the whole story rather just enough information to ask their doctor or search the Internet. Using the excuse that the regulations require all this complexity is abdicating the role FDA should have. We want drug DTC claim ads to be accurate and disclose serious risks. Surely, there is a better way. It will take FDA, Congress and drug makers to collaborate to determine how to improve. This is simple really and FDA should lead that effort.
Does anyone feel that we have done the proper job educating consumers when arcane medical terms are dominating DTC? Regulators tick off required boxes on their label checklist for DTC knowing full well consumers are often left clueless. My suggestion is OPDP have hearings on how to completely over haul DTC communication for today’s media environment, instead of using the excuse that they are captive to regulations written almost 50 years ago.
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