In a notice published in the Federal Register on May 7, 2014, the federal Food and Drug Administration (FDA) is soliciting comments on a proposed study entitled "Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements." The FDA's Office of Prescription Drug Promotion (OPDP) will investigate the impact of price comparison information to better understand how the information affects a reader's perception of a drug's overall safety and efficacy versus the comparator in direct-to-consumer and professional advertisements.
According to the FDA, when making pricing comparisons, advertisements should include contextual information asserting that the two drugs may not be comparable in terms of safety and efficacy. The ads should also state that the acquisition costs do not necessarily reflect the actual prices paid by consumers, pharmacies or third-party payers. The notice states, "[d]espite 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 study participants, recruited over the internet, will include general practice physicians (e.g., Family Practice, General Practice, Internal Medicine) and specialists (e.g., Endocrinology, Pain Management) and consumers who disclose that they have been diagnosed with diabetes. Study participants will view one of three different ads. One ad will provide information about the price of the product relative to a competitor for the same indication; a second will present the same information and include additional contextual information that the two drugs may not be comparable in terms of efficacy and safety, and that the acquisition costs do not necessarily reflect actual prices paid; and a third will provide claims about the price of the product but will not present information about the price relative to a competitor, and will act as a control.
After viewing the ads, participants will respond to questions assessing their perception and understanding of a product's safety and efficacy; their perception and understanding of the additional contextual information; their perception of comparative safety and efficacy; and their intention to seek more information about the product.
The FDA requests written comments regarding the proposed study by July 6, 2014. To access the May 7, 2014, Federal Register Notice, please click here.