FDA Plans Huge Study on How Public Understands Drug Risk

Regulatory NewsRegulatory News
| 19 November 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) is out with yet another proposed study on direct-to-consumer prescription drug advertising—its third proposed study in as many weeks—this time focusing on how patients understand the risks and benefits of drug products.


FDA frequently studies consumer behavior as it relates 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.
November 2014Impact of Spouse on Understanding of Drug Risks, BenefitsStudy to assess the "social contexts" a drug advertisement is seen in, with a focus on how a spouse can affect risk perception.

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.

Seeking Objective Data

One of the most interesting findings from FDA's past research, it said, is that while measurements of risk and benefit are internally valid, the findings "tend to vary by study." In other words, a consumer might consider a drug to be safe in a study, but there's no way of telling if that assessment would be the same for other drugs or other conditions.

What FDA wants, it said, is a "pool of reliable and valid measurement items for assessing consumers' drug risk and benefit perceptions—as well as other elements of prescription drug decision making—consistently across studies."

"Research suggests that consumers struggle with the concepts of risk and efficacy and often overestimate drug efficacy," FDA explains in its Federal Register notice on the study. Regulators, it said, want to know "how consumers are making sense of this information and how it impacts decisions related to prescription drugs."

A Study on Risk

Its new study is meant to create that pool of reliable measurements, it said.

The proposed study will test more than 10,000 patients in a bid to examine how they assess drug risk independently of other products. FDA will test patients in eight groups (four chronic pain ads and four hypertension ads) split between a population of those with hypertension or chronic pain and those from a "general population."

Each 1,250-person study group will view either a print or television advertisements representing a drug that is either high-risk or low-risk, and has either a high or low level of benefits.

OPDP Study Design

Study participants will be asked to assess their feelings about the drug's benefits and risks, as well as their intentions and attitudes toward the drug, FDA said.

Regulators said they hoped the survey would help them to "understand and accurately measure how consumers are making sense of this [advertised] information and how it impacts decisions related to prescription drugs."


Proposed FDA Study


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