FDA to Investigate Spousal Influence and DTC Drug Ads

The FDA is hoping that a study of spousal communication related to direct-to-consumer prescription drug advertising will help it make better recommendations for these ads.

The agency plans to study the effects of spousal influence on couples who are married or living together and where one has asthma. Participants will randomly be assigned to view an ad for a high-benefit and high-risk drug or a low-benefit and low-risk drug either alone or with a partner.

Those viewing the ad with a partner will have time to discuss it and then complete a questionnaire. Participants viewing alone will also answer the questionnaire.

The FDA believes that people make judgments about the drugs they see promoted on television in social contexts most of the time and that the presence of others can influence a person’s perceptions of a drug’s risks and benefits.

For example, the agency says in a notice in the Federal Register, the partner may reinforce negative perceptions about a drug’s risks or may emphasize the benefits of that drug over its risks. These may have larger consequences for public health if large numbers of patients are seeking prescriptions they don’t need, or deciding not to seek prescriptions they do need, CDER spokesman Stephen King said.

The FDA first proposed the study last November.

The agency has opened another comment period on docket no. FDA-2014-N-1819, which runs until June 26. Read the Federal Register notice at www.fdanews.com/05-22-15-spousalstudy.pdf. — Lena Freund