Does Your Spouse Affect How you Perceive Drug Safety? An FDA Study Aims to Find out

Regulatory NewsRegulatory News | 13 November 2014 |  By 

The US Food and Drug Administration (FDA) has announced another proposed study of consumers who watch drug advertising on TV—the second this week—this time trying to assess how spouses influence how consumers understand a drug's benefits and risks.


FDA frequently studies consumer behavior as it related to drug advertising. An overview of recent studies is as follows:

DateTopicStudy Summary
January 2012Corrective AdvertisingStudy to assess whether and how corrective advertising—used to correct information in a previous ad—works.
October 2012Promotional Ads and Healthcare ProfessionalsStudy to assess how advertisements and promotional materials affect prescribing habits.
May 2013Composite ScoresStudy to assess whether and how consumers understand "composite scores" used in DTC advertising.
July 2013Health Information AvailabilityAssessment of how consumers find health information about prescription medication
October 2013Adolescents and DTC AdvertisingStudy to assess how adolescents interpret drug risk in DTC advertising
February 2014Alternate Format for Major Risks in DTC Drug AdsProposed study of whether FDA should allow DTC ads to contain only the major risks associated with a drug.
May 2014Distractions in DTC AdvertisingStudy to assess whether "distractions" in DTC advertisements can make a drug seem safer than it is.
November 2014Effects of Repeated Exposure to DTC AdvertisingStudy to assess how repeated exposure to a single drug ad changes consumer behavior over time.

FDA's various studies have focused in large part on the ways in which consumers view DTC advertising, and how a wide range of factors can impact their assessment of a drug's benefits and risks.

New Study Proposed

Unlike most of the studies FDA has proposed since 2012, FDA's latest proposal focuses on the "social contexts" in which a direct-to-consumer advertisement is seen. Specifically, FDA notes that a "potential consumer and his or her spouse (e.g. marital or domestic partner) may view an ad together and discuss drug benefits, side effects and risks."

"These social interactions may result in unique reactions relative to consumers who view DTC prescription drug ads alone," FDA continues in its 13 November 2014 Federal Register notice. A person's spouse, for example, may express their concern about a particular risk posed by a drug, leading the person to take a more negative view of the drug.

To study whether spouses have an effect on how a drug's benefits and risks are perceived, FDA's Office of Prescription Drug Promotion (OPDP) plans to study participants under a variety of conditions.

Participants will be shown one of two advertisements: one which depicts a low-benefit and low-risk drug, and another depicting a high-benefit and high-risk drug. Patients will be randomly assigned to either view the ad alone or with their spouse, FDA said. Participants viewing the ad with their spouse will be given time to discuss the ad together before answering a survey.

The study will focus on patients with asthma. Spousal participants in the study should not have the condition, FDA said.


Federal Register notice


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