For most patients living in the US, turning on the TV and seeing an advertisement for a drug or pharmaceutical product is a common occurrence. In fact, these commercials have become an accepted part of daily TV viewing, and the drug industry spends billions of dollars every year on this direct-to-consumer marketing.

However, visit almost any other country in the world, and you will find quite the opposite.

In every nation besides the US and New Zealand, these kinds of commercials are not allowed as governments have concluded that advertising drugs for complex diseases direct to consumers is not appropriate. They feel that the average TV viewer is not qualified enough to fully understand or appreciate the risks involved in taking powerful medication, and should receive treatment advice from a licensed physician only, not a TV ad.

Clearly, the US thinks differently. In fact, the US Food and Drug Administration (FDA) is now even considering a policy that would expand direct-to-consumer drug marketing by allowing companies to pitch off-label uses of their drugs.

When a drug receives approval for market use, it is given a FDA packing label which contains detailed instructions regarding the approved use of the drug. Off-label use refers to the use of a drug in a manner that is not specified in this FDA approved label. This can mean using a drug to treat a different illness or a different age group of patients, or it can mean using a drug in a different form or dosage.

Although doctors are authorized to prescribe drugs off-label, the current rules in the US deny pharmaceutical companies the ability to promote this.  However, some within the healthcare industry have argued that consumers are key players in their healthcare management and, as such, they have a right to information about all drug uses, not just those prescribed to them by their doctors. The feel, therefore, that consumers could benefit from exposure to information about off-label uses of drugs in the ads they see on TV.

Conversely, there are others who have criticized the FDA’s decision to consider this expansion of direct-to-consumer marketing. These critics do acknowledge that there are some very valid and important off-label uses of prescription drugs, especially in the rare disease space where many patients do not have access to an approved medication.

However, they believe that, even in those special cases, the decision to use an off-label drug is almost always made by a physician, or another healthcare expert who is in the best position to understand both the risks and the rewards involved. They are of the opinion that a 30-second TV advertisement cannot possibly convey the complexity of off-label use, nor the risks involved, and that these issues should never be addressed in such a slapdash or casual manner.

These critics have been appealing to the FDA since the new policy was unveiled in November of 2016, but the FDA has yet to make a decision, so watch this space.