In a Federal Register Notice scheduled to publish on Monday April 6th, FDA outlines a proposal to study the comparative advertising of prescription drug products. In the notice, FDA states:
By their very nature, medical and health decisions are comparative (e.g., treat versus not treat). For consumers, these decisions may include the use of prescription drug products versus over the counter products versus herbal supplements, as well as one prescription brand versus another prescription brand. Similarly, advertising is often comparative. In prescription drug advertising, sponsors are permitted to include truthful, non-misleading information about the price of their products in promotion. This may extend to price comparison information, wherein sponsors may include information about the price of a competing product in order to make advantageous claims. Currently, when price comparisons are made, the advertisement (ad) should also include context that the two drugs may not be comparable in terms of efficacy and safety and that the acquisition costs presented do not necessarily reflect the actual prices paid by consumers, pharmacies, or third party payers. Despite the inclusion of this additional information, there is concern that adding contextual information about efficacy or safety is not sufficient to correct the impression that the products are interchangeable and that price is the main factor to consider. The Office of Prescription Drug Promotion plans to investigate, through empirical research, the impact of price comparison information and additional contextual information on prescription drug product perceptions. This will be investigated in direct-to consumer (DTC) and healthcare-directed professional advertising for prescription drugs.
OPDP outlies their proposed study design to incorporate the use of physicians and consumers. They will develop a fictional drug and scenario around the drug and will recruit actual patients suffering from the disease the fictional drug is supposed to treat. The Agency acknowledges that price comparison of two products is not a simple matter, as there are other obvious safety and efficacy considerations that must be factored into the assessment and evaluation. Hopefully, the study will be able to guide the Agency in understanding the benefit and pitfalls of such comparative data so they can develop a framework for such advertising.
The study design and details of the approach the Agency plans to take, as well as comments previously submitted to an initial FR notice on the topic, are discussed. The FR notice can be found here.