FDA plans to study medication adherence claims, endorser effect in DTC advertising

Regulatory NewsRegulatory News | 22 September 2022 |  By 

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) said it plans to conduct two studies looking into patient and physician perceptions of medication adherence claims in online ads and how endorser status and actual-use disclosures impact viewers’ perception of drugs in television ads.
On 22 September, OPDP announced its plans to study how online advertisements for drugs that include claims of improved medication adherence are perceived by consumers and primary care physicians.
FDA noted that medication non-adherence is a well-known challenge in health care, and it is estimated that only half of the patients with chronic illnesses take their medication as prescribed. Pointing to recent research, the agency said that up to 100,000 people die preventable deaths each year due to medication non-adherence, resulting in $100 billion in added costs to the health care system.
“As attention to the public health issue of medication adherence has grown, OPDP has noted a corresponding increase in the number of claims and presentations in prescription drug promotion that focus, either directly or through implication, on a product’s potential to improve adherence to treatment regimens,” FDA said. “Many of these presentations include information about options and capabilities available to help patients track their medication usage.”
FDA said that many of those options use software connected to devices such as a patient’s smartphone to not only track but alert patients when they need to take their medication. However, they note that there isn’t enough data on how consumers perceive such capabilities.
“Very little is known about patient and health care provider perceptions of products that track medication use or that work in tandem with software to track medication use, with most commentaries having been largely theoretical,” said FDA. “The focus of the present study is to explore patient and health care provider perceptions of a fictitious prescription drug product that is accompanied by software that is intended to track medication use.”
FDA said it plans to run a two-part study that includes an initial study with 50 consumers and 50 primary care physicians who will be pretested using a web-based questionnaire. Afterwards, the agency will recruit 350 consumers who self-identify as having diabetes and 350 physicians who treat diabetes to evaluate five different consumer web pages for a fictitious prescription diabetes treatment that aims to understand the effect of drug-adherence claims.
Endorser status and ‘actual use’
FDA also plans to add to ongoing research into how different endorsers of drugs are perceived by consumers and health care providers. The ongoing study is set to complete in 2024 and looks at different types of DTC endorsers in print or on websites. Now, the agency wants to conduct an additional study that focuses on television ads titled, “Endorser Status and Actual Use in Direct-to-Consumer Television Ads.
The agency said that past research has shown that consumers are most likely to buy a drug if it has been endorsed by an expert physician or pharmacist, followed by endorsements from other consumers and lastly by a celebrity.
“The present research will specifically examine the influence of two independent variables – endorser type (patient, physician) and an actual-use disclosure (utilizer, actor, none) — in television advertisements,” said the FDA. “Dependent variables will include perceptions of the risks and benefits of the promoted prescription drug, attitudes toward and perceptions of the endorser, attention paid to the ad, and behavioral intentions.”
The agency also plans to study whether the age and education level of the consumer influences their perception of the ad.
The study will be broken into two parts. The first study will look at the perceptions of patients who have been diagnosed with diabetes and the second will be for patients with rheumatoid arthritis. In both studies, participants will be shown ads for a fictitious drug and will record their perceptions based on whether the endorser is a patient or a physician.
Pretests of each study will recruit 126 consumers who either self-identify as having diabetes or rheumatoid arthritis. Then, FDA will conduct main studies with similar cohorts with 648 self-identified patients in each disease area.
The studies are the latest in a series of research FDA is conducting to understand prescription drug promotion, including one proposed last year to investigate how claims, graphics and disclosures about targeted mechanisms of action (MoA) influence consumer and health care provider (HCP) perceptions. FDA announced that it plans to proceed with that study, with some revisions made based on input it received during the public comment period. (RELATED: OPDP plans more research on presentation of 'targeted' MoAs, Regulatory Focus 27 October 2021)


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